fpp presentation in pregnancy

Breech, posterior, transverse lie: What position is my baby in?

Fetal presentation, or how your baby is situated in your womb at birth, is determined by the body part that's positioned to come out first, and it can affect the way you deliver. At the time of delivery, 97 percent of babies are head-down (cephalic presentation). But there are several other possibilities, including feet or bottom first (breech) as well as sideways (transverse lie) and diagonal (oblique lie).

Fetal presentation and position

During the last trimester of your pregnancy, your provider will check your baby's presentation by feeling your belly to locate the head, bottom, and back. If it's unclear, your provider may do an ultrasound or an internal exam to feel what part of the baby is in your pelvis.

Fetal position refers to whether the baby is facing your spine (anterior position) or facing your belly (posterior position). Fetal position can change often: Your baby may be face up at the beginning of labor and face down at delivery.

Here are the many possibilities for fetal presentation and position in the womb.

Medical illustrations by Jonathan Dimes

Head down, facing down (anterior position)

A baby who is head down and facing your spine is in the anterior position. This is the most common fetal presentation and the easiest position for a vaginal delivery.

This position is also known as "occiput anterior" because the back of your baby's skull (occipital bone) is in the front (anterior) of your pelvis.

Head down, facing up (posterior position)

In the posterior position , your baby is head down and facing your belly. You may also hear it called "sunny-side up" because babies who stay in this position are born facing up. But many babies who are facing up during labor rotate to the easier face down (anterior) position before birth.

Posterior position is formally known as "occiput posterior" because the back of your baby's skull (occipital bone) is in the back (posterior) of your pelvis.

Frank breech

In the frank breech presentation, both the baby's legs are extended so that the feet are up near the face. This is the most common type of breech presentation. Breech babies are difficult to deliver vaginally, so most arrive by c-section .

Some providers will attempt to turn your baby manually to the head down position by applying pressure to your belly. This is called an external cephalic version , and it has a 58 percent success rate for turning breech babies. For more information, see our article on breech birth .

Complete breech

A complete breech is when your baby is bottom down with hips and knees bent in a tuck or cross-legged position. If your baby is in a complete breech, you may feel kicking in your lower abdomen.

Incomplete breech

In an incomplete breech, one of the baby's knees is bent so that the foot is tucked next to the bottom with the other leg extended, positioning that foot closer to the face.

Single footling breech

In the single footling breech presentation, one of the baby's feet is pointed toward your cervix.

Double footling breech

In the double footling breech presentation, both of the baby's feet are pointed toward your cervix.

Transverse lie

In a transverse lie, the baby is lying horizontally in your uterus and may be facing up toward your head or down toward your feet. Babies settle this way less than 1 percent of the time, but it happens more commonly if you're carrying multiples or deliver before your due date.

If your baby stays in a transverse lie until the end of your pregnancy, it can be dangerous for delivery. Your provider will likely schedule a c-section or attempt an external cephalic version , which is highly successful for turning babies in this position.

Oblique lie

In rare cases, your baby may lie diagonally in your uterus, with his rump facing the side of your body at an angle.

Like the transverse lie, this position is more common earlier in pregnancy, and it's likely your provider will intervene if your baby is still in the oblique lie at the end of your third trimester.

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What to know if your baby is breech

What's a sunny-side up baby?

What happens to your baby right after birth

A newborn baby wrapped in a receiving blanket in the hospital.

How your twins’ fetal positions affect labor and delivery

illustration of twin babies head down in utero

BabyCenter's editorial team is committed to providing the most helpful and trustworthy pregnancy and parenting information in the world. When creating and updating content, we rely on credible sources: respected health organizations, professional groups of doctors and other experts, and published studies in peer-reviewed journals. We believe you should always know the source of the information you're seeing. Learn more about our editorial and medical review policies .

Ahmad A et al. 2014. Association of fetal position at onset of labor and mode of delivery: A prospective cohort study. Ultrasound in obstetrics & gynecology 43(2):176-182. https://www.ncbi.nlm.nih.gov/pubmed/23929533 Opens a new window [Accessed September 2021]

Gray CJ and Shanahan MM. 2019. Breech presentation. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK448063/ Opens a new window [Accessed September 2021]

Hankins GD. 1990. Transverse lie. American Journal of Perinatology 7(1):66-70. https://www.ncbi.nlm.nih.gov/pubmed/2131781 Opens a new window [Accessed September 2021]

Medline Plus. 2020. Your baby in the birth canal. U.S. National Library of Medicine. https://medlineplus.gov/ency/article/002060.htm Opens a new window [Accessed September 2021]

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Fetal Presentation, Position, and Lie (Including Breech Presentation)

, MD, Children's Hospital of Philadelphia

Variations in Fetal Position and Presentation

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Presentation refers to the part of the fetus’s body that leads the way out through the birth canal (called the presenting part). Usually, the head leads the way, but sometimes the buttocks (breech presentation), shoulder, or face leads the way.

Position refers to whether the fetus is facing backward (occiput anterior) or forward (occiput posterior). The occiput is a bone at the back of the baby's head. Therefore, facing backward is called occiput anterior (facing the mother’s back and facing down when the mother lies on her back). Facing forward is called occiput posterior (facing toward the mother's pubic bone and facing up when the mother lies on her back).

Lie refers to the angle of the fetus in relation to the mother and the uterus. Up-and-down (with the baby's spine parallel to mother's spine, called longitudinal) is normal, but sometimes the lie is sideways (transverse) or at an angle (oblique).

For these aspects of fetal positioning, the combination that is the most common, safest, and easiest for the mother to deliver is the following:

Head first (called vertex or cephalic presentation)

Facing backward (occiput anterior position)

Spine parallel to mother's spine (longitudinal lie)

Neck bent forward with chin tucked

Arms folded across the chest

If the fetus is in a different position, lie, or presentation, labor may be more difficult, and a normal vaginal delivery may not be possible.

Variations in fetal presentation, position, or lie may occur when

The fetus is too large for the mother's pelvis (fetopelvic disproportion).

The fetus has a birth defect Overview of Birth Defects Birth defects, also called congenital anomalies, are physical abnormalities that occur before a baby is born. They are usually obvious within the first year of life. The cause of many birth... read more .

There is more than one fetus (multiple gestation).

Position and Presentation of the Fetus

Some variations in position and presentation that make delivery difficult occur frequently.

Occiput posterior position

In occiput posterior position (sometimes called sunny-side up), the fetus is head first (vertex presentation) but is facing forward (toward the mother's pubic bone—that is, facing up when the mother lies on her back). This is a very common position that is not abnormal, but it makes delivery more difficult than when the fetus is in the occiput anterior position (facing toward the mother's spine—that is facing down when the mother lies on her back).

Breech presentation

In breech presentation, the baby's buttocks or sometimes the feet are positioned to deliver first (before the head).

When delivered vaginally, babies that present buttocks first are more at risk of injury or even death than those that present head first.

The reason for the risks to babies in breech presentation is that the baby's hips and buttocks are not as wide as the head. Therefore, when the hips and buttocks pass through the cervix first, the passageway may not be wide enough for the head to pass through. In addition, when the head follows the buttocks, the neck may be bent slightly backwards. The neck being bent backward increases the width required for delivery as compared to when the head is angled forward with the chin tucked, which is the position that is easiest for delivery. Thus, the baby’s body may be delivered and then the head may get caught and not be able to pass through the birth canal. When the baby’s head is caught, this puts pressure on the umbilical cord in the birth canal, so that very little oxygen can reach the baby. Brain damage due to lack of oxygen is more common among breech babies than among those presenting head first.

Breech presentation is more likely to occur in the following circumstances:

Labor starts too soon (preterm labor).

Sometimes the doctor can turn the fetus to be head first before labor begins by doing a procedure that involves pressing on the pregnant woman’s abdomen and trying to turn the baby around. Trying to turn the baby is called an external cephalic version and is usually done at 37 or 38 weeks of pregnancy. Sometimes women are given a medication (such as terbutaline ) during the procedure to prevent contractions.

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Eliza Chakravarty 1 ,
Megan E B Clowse 2 ,
Daphnee S Pushparajah 3 ,
Sarah Mertens 3 ,
Caroline Gordon 4
1 Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma , USA
2 Duke University Medical Center, Durham, North Carolina , USA
3 UCB Pharma, Brussels , Belgium
4 School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham , UK
Correspondence to Dr Eliza Chakravarty; Eliza-Chakravarty{at}omrf.org

Objectives To identify family planning and pregnancy (FPP) issues for female patients of childbearing age living with a chronic inflammatory disease and to assess whether current clinical practice routinely provides adequate support to alleviate these concerns.

Setting Multinational survey and an analysis of online patient activity.

Participants Premenopausal women (aged 20–45 years; N=969) were surveyed in the USA, the UK, Germany, France, Italy and Spain. Rheumatologists were surveyed in Germany (N=50), France (N=50), Italy (N=50) and the USA (N=100), and gastroenterologists were also surveyed in the USA (N=100).

Primary and secondary outcome measures Two online surveys were undertaken to identify FPP issues for physicians and patients. The surveys examined the frequency of dialogue on these topics between physicians and patients, alongside assessment of patient satisfaction regarding these conversations. Online analysis identified key themes for patient discussion outside their doctors’ office/clinic/surgery.

Results 32–56% of physicians spontaneously reported having talked about FPP with their female patients of childbearing age. When prompted, the majority of rheumatologists (74–92%) and gastroenterologists (74%) reported having discussed conception/pregnancy with female patients; however, less than half reported consulting their patient's treating general practitioner/gynaecologist about these topics. The majority of patients reported their FPP-related concerns are not adequately addressed/settled during their medical appointments. Furthermore, only 30–40% of patients considered advice/information to be consistent across multiple healthcare professionals. Key online FPP-related patient discussions included disease state, adverse effects, treatment, switch behaviour and wash-out requirements.

Conclusions Female patients who live with chronic inflammatory disease have important FPP concerns. The majority of patients, however, do not feel that their FPP concerns are adequately addressed in current clinical practice and report that they receive inconsistent advice from the various healthcare professionals who manage different aspects of their care. There is a clear need for provision of up-to-date and consistent information/support to female patients.

Autoimmune disease
Inflammatory disease
Family Planning

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjopen-2013-004081

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Strengths and limitations of this study

Strength: Investigation of patient and physician perspectives.

Strength: Involvement of specialties from different areas of interest.

Strength: Cross-cultural investigation.

Weakness: Absence of formal survey validation.

Weakness: Reliance on patient self-reporting.

Introduction

Autoimmune and inflammatory diseases often affect women of reproductive age. Although rheumatoid arthritis (RA) becomes more common as patients age, 1 women are increasingly choosing to start their family later in life and treatments to control RA are now often started at a younger age. Moreover, even though only a minority proportion of patients with RA are women of childbearing age, 2 the high prevalence of the disease means that it does impact a significant number of young women. Many other inflammatory diseases, including ankylosing spondylitis, 3 , 4 Crohn's disease (CD), 5 , 6 inflammatory bowel disease (IBD) 7 and systemic lupus erythematosus (SLE), 8 also affect a younger population and thus have a direct effect on women of childbearing age.

Pregnancy and child rearing are important facets of life for most women. Now that improved therapies for inflammatory diseases have enabled better physical function and quality of life, many women who previously would have felt too ill to consider child bearing are now better able to fulfil desires for family life. Family planning and pregnancy (FPP) are also important issues for this patient population as these disease states have been linked to an increased risk of adverse pregnancy outcomes, 9–11 including increased risk of preterm birth, 12 difficulty carrying to full term 13 and a possible reduction in fertility, 14 , 15 although there is conflicting evidence regarding the impact of inflammatory diseases on fertility. 16 , 17 Owing to the impact on pregnancy outcomes, expert advice is to achieve and maintain stable low disease activity prior to conception and throughout pregnancy. 18–20 Some anti-inflammatory treatment options can be potentially hazardous for pregnant women to take as drugs can pass across the placenta and may affect the fetus. 21 Methotrexate, a common RA treatment, can be damaging to fetal development (at least at high doses) 22 , 23 while other disease-modifying antirheumatic drugs such as leflunomide have been shown to cause malformations in animal studies. 24

However, use of medications during pregnancy is not always contraindicated and an individual risk–benefit discussion should be undertaken between the patient and expert physician to provide the best management of the disease and the pregnancy. 25 Inadequate dissemination of appropriate advice describing which drugs may be continued can lead to women unnecessarily forgoing potentially helpful medications and thus suffering throughout pregnancy, with the increased risk of further complications to both mother and child due to the effects of active disease. 26 Furthermore, patients are increasingly seeking additional information on the internet, 27 while a recent analysis of information regarding medication safety on active internet sites has noted an inadequate evidence base for the advice often provided and inconsistent guidance. 28 It is clear that communication of reliable and consistent information is required to enable the correct treatment of these women before and during pregnancy, and while breastfeeding. Education and information should be shared by healthcare professionals dealing with these diseases, medications and situations on a daily basis. Accurate, consistent information must be communicated to women considering or entering pregnancy in order to support patients through this delicate journey.

Two surveys were undertaken to investigate some of these issues, one for physicians and another for female patients, to identify the key concerns of both groups related to the topics of FPP in inflammatory disease. The surveys were designed to gauge whether there is a gap in the communication between what healthcare professionals provide in terms of information/support and what patients feel that they receive. The patient survey also investigated where patients go to seek additional information. Two key objectives of the study were to examine the proportion of physicians who discuss FPP issues with their female patients of childbearing age and the proportion of patients who have discussed these topics, in the context of their condition, with their healthcare professional. The survey also assessed the proportion of patients who feel that their concerns on this topic have been satisfactorily addressed by these discussions. We aim to communicate the insights gained from this investigation to clinicians treating women of childbearing age, who live with chronic inflammatory conditions, in order to provide advice on how best to support these patients.

This study complied with the ICC/ESOMAR, EphMRA, ABPI, MRS and BHBIA market research codes of conduct, ensuring the anonymity and confidentiality of all participants. Respondents were paid a nominal amount, calculated using fair market value guidance, to compensate for the time and effort of completing the survey.

Physician survey

The online physician questionnaire was delivered in two phases, the first phase (baseline) was distributed in July 2012 (Europe) and September 2012 (USA), and the second phase was distributed in November 2012 in Europe and the USA. The survey was delivered in the local language and translations were checked for consistency against the original in English by native speakers with fluency in both languages (the complete Physician Questionnaire can be found in online supplementary appendix 1). The questionnaire was designed to elicit spontaneous (open-ended question) and prompted (closed question in which FPP topics were an option among other answering categories) responses. Participants were recruited from the WorldOne Physician Panel. Rheumatologists were surveyed in four countries: Germany (N=50), France (N=50), Italy (N=50) and the USA (N=100). Gastroenterologists were surveyed in the USA (N=100). Responses were compared between phases using two-sided z-tests with significance level 0.05, which corresponds to a CI of 95%.

Participating physicians had to meet the following criteria: 3–30 years of experience, ≥50% patient-facing time, had not participated in medical research within their specialist area in the past month, were not currently a clinical investigator for a pharmaceutical manufacturer and were not currently active in medical research or advertising (to avoid inclusion of respondents motivated only by receipt of payment). Physicians with rheumatology as their primary specialty had to meet the following additional criteria: treat ≥20 RA patients/month and have ≥10 patients on biologics/month. Physicians with gastroenterology as their primary specialty had to meet the following additional criteria: treat ≥8 CD patients per/month and have ≥2 patients on biologics/month. These selection criteria were applied to ensure participating physicians had sufficient experience treating patients with systemic inflammatory disease in order to provide informative results, while also seeking to include physicians with a range of experience in order to investigate routine clinical practice.

Patient survey

The online patient questionnaire was designed according to standard market research survey methodology, including scaling questions and avoiding skewed questions. The questionnaire was delivered in the local language and translations were checked for consistency against the original in English by native speakers with fluency in both languages (the complete Patient Questionnaire can be found in online supplementary appendix 2). The questionnaire was targeted at premenopausal women (age was self-declared and the survey excluded women under 20 and over 45 years of age; see Question 3 Patient Survey). A professional recruitment agency was used to recruit patients from the GlobalTestMarket and MySurvey online survey panels. Respondents were screened according to age, gender and disease (all self-reported) and those who were <20 or >45 years old, male, or not suffering from RA, CD or lupus were excluded. Recruited patients were then sent a link to an online survey, which was followed up by a short telephone interview at a prearranged time.

The patient questionnaire was delivered in two phases and was distributed in six countries (the USA, the UK, Germany, France, Italy and Spain). The first phase (baseline) consisted of 16 questions and was disseminated to patients between 17 July 2012 and 15 August 2012. There were 1069 respondents to the first phase which covered patients with RA, SLE, CD and ulcerative colitis (UC). The second phase consisted of the original 16 questions from the first phase plus an additional 8 questions included in order to avoid so-called false positives (ie, covered topics included in other questions to test consistency of response) and to provide greater insight into patients’ experience in terms of medical care and needs. The second phase elicited 969 responses and was distributed between 13 October 2012 and 16November 2012 to patients with axial spondyloarthritis and psoriatic arthritis, in addition to patients with RA, SLE, CD and UC. All responses were anonymous. The patients who were invited to participate in the two survey phases were not identical, although there may have been some overlap (responses were anonymous therefore the extent of overlap could not be determined).

Netnography research

Online discussions (English language only) relating to FPP issues were investigated using two approaches: social media monitoring and search engine landscape/content analysis (SELA).

Social media monitoring was undertaken by identifying categories of interest (defined as: ‘ulcerative colitis’, ‘systemic lupus erythematosus’, ‘rheumatoid arthritis’, ‘colitis ulcerosa’, ‘lupus’, ‘regional enteritis’ and ‘Crohn's disease’) and keywords of interest (defined as: ‘pregnancy’, ‘miscarriage’, ‘birth control’, ‘miscarriages’, ‘fertile’, ‘family planning’, ‘gestation’, ‘pregnant’, ‘fertility’, ‘pregnancy disease evolution’, ‘disease transfer to baby’, ‘breastfeeding’, ‘breast feeding’, ‘conception’, ‘conceived’ and ‘placental transfer’), and then combining keywords together with the categories of interest to ensure coverage of all topics of interest.

SELA methodology involved identification of keywords (including generic keywords/keyword phrases and specific keywords/keyword phrases), assessment of keyword search volume and ranking of individual sites in search engine results. The ‘click through rate’ was combined with the ‘monthly search volume’ to estimate the ‘share of attention index’. The final keyword pool included the categories ‘colitis ulcerosa’, ‘ulcerative colitis’, ‘Crohn's disease’, ‘lupus’, ‘rheumatoid arthritis’, ‘regional enteritis’ and ‘systemic lupus erythematosus’, and the following FPP-related keywords ‘gestation’, ‘birth control’, ‘pregnancy’, ‘fertility’, ‘miscarriage’ and ‘family planning’.

Many rheumatologists and gastroenterologists spontaneously reported having discussed FPP-related topics with their female patients of childbearing age; reports were consistent across all countries studied ( figure 1 A). Interestingly, the number of US gastroenterologists who discussed these topics with their female patients increased significantly between the first and second phases of the survey ( figure 1 A). This was particularly true for fertility, pregnancy and/or family planning issues specifically, in which the percentage of US gastroenterologists discussing these topics increased from 67% to 79% between the two phases (significant difference, 95% confidence level; N=100 for both survey phases); however, there was no difference in European practice, with levels remaining at 60%.

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Frequency of physician-initiated discussions regarding family planning and pregnancy issues with female patients and their general practitioners or gynaecologists (survey phase 2 data shown in B and C). Ga, gastroenterologist; Rh, rheumatologist. *p<0.05 compared to phase 1 (two-sided z-test with significance level 0.05).

When prompted, the majority of rheumatologists (74–92%) and gastroenterologists (74%) reported having discussed conception/pregnancy with female patients of childbearing age. However, less than half of these physicians discussed FPP-related issues with their patient's treating general practitioner (GP; ie, primary care physician) or gynaecologist ( figure 1 B,C; survey phase 2 data shown; see Questions 20 and 21 Physician Survey online supplementary appendix 1).

When seeking additional information regarding FPP, community rheumatologists and gastroenterologists reported currently relying on presentations and educational events at congresses, other healthcare professionals and key opinion leaders as their preferred sources of information.

Patient survey and netnography analysis

Patients reported that the frequency of FPP-related conversations during their medical appointments was lower than their discussions about emotional well-being and employment ( figure 2 A), although most female patients of childbearing age reported discussing these issues at some point during their care pathway ( figure 2 B).

Patient-reported (patient survey) topics of discussion with specialist physicians, the frequency of patient-initiated family planning and pregnancy (FPP) discussion and the importance of FPP issues stratified by patient age (data from survey phase 2 shown in C).

Patients currently on medication for the treatment of their condition reported being more concerned about FPP issues than those not receiving medication, with 63% of those on medication reporting that pregnancy was a concern compared with only 32% of patients not receiving medication. In addition, the female age group with most concerns related to FPP was between the ages of 30 and 34 ( figure 2 C; survey phase 2 data shown, similar trend observed in phase 1). Concern was high between the ages of 25 and 39 but decreased in patients aged between 40 and 45.

Patients were asked when they would prefer to discuss the topics of FPP. The survey revealed patients prefer to discuss these issues in the context of their disease and treatment whenever a decision is made that could have an impact on their family planning or ability to become pregnant ( figure 3 A). Approximately a quarter feel that one conversation with their healthcare professional on this topic is enough, although some would like to discuss these topics at every visit. Furthermore, approximately a third of patients prefer to initiate conversations on this topic themselves or to obtain information from their healthcare professional when appropriate to their individual situation.

Patient preference for frequency of discussions relating to family planning and pregnancy issues and identification of issues that prevented discussion (data from patient survey phase 2 shown).

Patients gave a range of reasons for not discussing FPP concerns with their healthcare provider, with the most common reason being that they forgot to mention it ( figure 3 B). Other important reasons identified as barriers for discussing FPP was the impression that the healthcare professional either did not have time for discussions or that they were not the correct physician to provide advice on these topics. Importantly, some patients also reported that they choose to not discuss FPP issues as they were reluctant to change medication. Very few patients felt that their healthcare professional was reluctant to discuss these topics. Over a quarter of respondents indicated that they had ‘other’ reasons for not discussing these issues with their doctor ( figure 3 B). A higher proportion (39%) of patients aged 40–45 years recorded ‘other’ reasons for not discussing FPP issues with their doctor, compared with younger patients (‘other’ was recorded by 21.7% of 20–24, 18.3% of 25–29, 18.7% of 30–34 and 25.6% 35–39-year-olds).

Patients report a preference for seeking information regarding FPP from their gynaecologist ( figure 4 A), whereas disease specialists (eg, rheumatologist or gastroenterologist) are their key contact point for management of their chronic condition ( figure 4 B). GPs/primary care physicians were also identified by patients as central to their discussions of both FPP and their chronic condition ( figure 4 A–B). It should be noted, however, that patient reports of a preference for one specialist over another regarding FPP discussions could be expected to vary by country given differences in treatment practices. For example, in the USA patients may commonly visit a gynaecologist/obstetrician for all pregnancy care, whereas in the UK the patient's GP and local midwife may oversee most of their pregnancy planning and management. In addition, when responding to the survey some, but not all, patients may have regarded the terms ‘obstetrician’ and ‘gynaecologist’ as interchangeable based on their own experience.

Patient preference for choice of healthcare provider for discussions of their condition and family planning and pregnancy (FPP) issues, and their preferred source of additional information (outside doctors’ office/clinic/surgery) relating to their condition and FPP issues (data from patient survey phase 2 shown). GP, general practitioner.

Other than their doctors’ office/clinic/surgery, patients reported researching and discussing information regarding FPP through multiple channels ( figure 4 C): predominantly on disease-related websites and with family and friends. In addition, patients reported that specific condition-related forums/patient organisations did not play a prominent part in their search for online information on these topics. A number of key themes, such as discussions around disease state, adverse effects, treatment, switch behaviour and wash-out requirements, emerged after following online patient activity. Other themes noted were patient emotions and feelings, interactions with healthcare professionals, how best to identify the correct healthcare professional for their treatment, concerns about inconsistent advice, infertility, sexuality and conception, disease carry-over to the baby, placental transfer of treatments, and breastfeeding.

Importantly, approximately 30–55% of female patients reported that their concerns relating to FPP are not adequately addressed or settled during their medical appointments (data from patient survey phase 2). Some variability in this response was observed across countries, with 30% of patients from the USA, 34% from Italy, 35% from Spain, 39% from the UK, 43% from France and 54% from Germany reporting that their concerns were not settled (data from patient survey phase 2). Patients also reported that consistency of advice and information given by multiple healthcare professionals, including nurses, was low with only about 30–40% of patients reporting consistent advice. Again, responses to this question varied across countries with 33% of patients from Spain and the UK reporting consistent advice, 36% from Germany and Italy, 40% from the USA and 41% from France (data from patient survey phase 2). Inconsistent advice was reported by about 30–50% of patients overall: 27% from Italy, 32% from Spain, 38% from France, 41% from the USA, 44% from Germany and 49% from the UK (remaining patients selected a neutral response to this question; data from patient survey phase 2).

The investigation described here was carried out to illuminate some of the issues surrounding FPP for female patients of childbearing age who live with chronic inflammatory diseases. Recently it was reported that almost half of female patients with IBD feel their disease and/or treatment influences their decisions about FPP but despite this about two-thirds had not discussed these issues with their doctor. 29 The results from the current study confirmed that FPP are considered important issues by this group of female patients and that there are key gaps in communication which result in inconsistent advice and subsequent patient concern/confusion. Importantly, the majority of female patients of childbearing age reported that current clinical practice does not adequately address their concerns related to FPP in inflammatory disease.

Some clinical recommendations for the management of inflammatory disease during pregnancy have been published 18–20 , 25 , 30 and advise that clinical remission/stable low disease activity be achieved prior to conception and maintained throughout pregnancy using appropriate therapy as needed. However, in the current study few patients reported discussing FPP at the point their condition was stable enough to become pregnant, suggesting a gap in necessary communication from physicians to patients regarding the need to control disease activity prior to conception, the impact of disease activity on pregnancy outcomes and the need to adjust medications during pregnancy. Indeed, a general lack of patient knowledge regarding continued use of medication during pregnancy was highlighted recently by a survey of female patients with IBD which revealed a widespread, but inaccurate, belief that all medications needed to be stopped during pregnancy. 29 Respondents to the current patient survey also reported that inconsistencies in advice regarding the use of anti-inflammatory and immunosuppressive medications during pregnancy are common. Together, these results suggest a need for continuing education of all specialists involved in the care of women with inflammatory disease in order to ensure women understand the implications of their condition and treatment on FPP. Congress presentations and associated education events were identified by physicians, specifically rheumatologists and gastroenterologists, as their currently preferred source of information and continuing education—which may also be applicable to other specialists. As such, these events should be actively targeted to maximise and improve continued education. This could, for example, include hosting discussion forums between specialists involved in different aspects of care for these patients at international and national congresses. Timely discussion of FPP issues is also an important consideration given that a high percentage of pregnancies are unplanned. 31

GPs/primary care physicians and gynaecologists were identified by patients as frequently central to their discussions on FPP issues, although research has previously shown that 41% of GPs do not initiate discussion of FPP with female patients affected by IBD. 29 Importantly a gap in communication was identified between these physicians and the specialists who treat chronic inflammatory diseases. As such, improved cross-specialty communication should be strongly encouraged, particularly for discussions regarding planning and treatment guidelines. This could involve establishment of cross-specialty teams within hospitals/centres of excellence to co-ordinate care of pregnant women living with systemic inflammatory disease. A recent survey of GPs in Ireland did show that the majority of GPs report seeking additional advice on FPP issues, in relation to their female patients with IBD, from tertiary specialists 29 so improved education for all specialties, and fostering communication should assist dissemination of information and consistent advice for patients. Furthermore, all of those involved in the care of female patients of childbearing age who live with chronic inflammatory disease, not only the immunological disease specialists, should be exposed to continued education on this topic. Another recent survey of rheumatologists and obstetricians showed that there is variability in advice given to patients concerning the use of specific medication during pregnancy. 32 This highlights a need for consistency among clinicians to achieve quality patient care. Development of cross-specialty international guidelines/consensus papers by relevant expert physicians may help bridge these gaps in communication. Furthermore, publication of evidence-based discussions of the risks and benefits of medication use and disease activity control during pregnancy in women with inflammatory diseases, by relevant medical societies, could provide an easily accessible resource for physicians and patients alike. These could be in the form of ‘white papers’ and accompanying patient information pieces, published in the scientific literature and online, to provide consistent education and advice for cross-specialty physicians and their patients.

In order to improve the dissemination of information regarding FPP to patients, it is important to identify when patients prefer to receive such information and also why this information may not be adequately communicated. Patient preference regarding timing of discussions about FPP varied. This variability may be due to the personal nature of this topic, differences in retention of information and differences in healthcare services/societal norms across different countries. Patients did, however, generally report that they wished to discuss FPP-related issues with their specialist physician (ie, rheumatologist or gastroenterologist) every time a decision was made that could impact on their FPP. As such, healthcare professionals should routinely consider any issues that affect fertility or pregnancy and offer to have a conversation with their patient regarding these issues at every clinic visit, unless it is known not to be relevant. It may also be useful to clarify patient expectations for support and advice during these discussions. Patients on medication were more concerned about FPP issues than those not receiving medication, as were female patients between the ages of approximately 25 and 40. The high level of concern in both of these groups highlights these patients as key populations requiring additional consideration, although it could be argued that all women of childbearing age should be targeted for such communications.

The most common reason patients offered to explain why they did not raise FPP with their healthcare provider was that they forgot to mention it during their consultation. Many also stated they avoided such discussion as they did not want to change their medication, implying that a fear of destabilising their disease could influence the preparedness of patients to discuss FPP topics. Other key reasons identified were the impression that their physician did not have time for the discussion or that they felt their treating physician was not the correct physician to consult on these topics. Consequently, physicians should consider periodically raising the issue themselves, particularly when treatment decisions or disease activity could impact FPP plans. Notably over a quarter of respondents indicated that they had ‘other’ reasons for not discussing these issues with their doctor. It is possible that this high response was due to patient demographics (eg, age, social background or current use of contraception) and patients considering their family already complete. Indeed, a higher proportion of older patients recorded ‘other’ reasons for not discussing FPP issues with their doctor compared with younger patients. Patient emotions was an important theme identified for online discussions, perhaps particularly relevant for those with a history of miscarriage/stillbirth or infertility problems, and it should also be considered that such associations could be a factor underlying why some patients reported that they did not discuss FPP with their physician for ‘other’ reasons.

Of key importance, many female patients of childbearing age reported that they did not feel that their concerns relating to FPP in the context of their disease were adequately addressed during their medical appointments. There was some variability in patient response across countries to this question, suggesting that cultural differences and differences in healthcare system structure may contribute to the variability in patient satisfaction. However, it is clear that there can be a definite improvement in the response to these issues and all healthcare professionals should consider how they could increase such communication and support to their patients. This could include provision of better patient educational material and advice on reliable and up-to-date websites containing FPP-related information. Indeed, patients reported that they frequently sought information online, although specific condition-related forums/patient organisations did not appear to be common sources of this information. Furthermore, the online landscape was fragmented by disease area, with no specific resource (beyond ‘Motherisk’; http://www.motherisk.org ) that provides FPP guidance on common autoimmune conditions and medication use affecting women in the reproductive age group. As such, development of a single site with consistent up-to-date guidance covering topics identified by patients as key interests would probably be of great value. Alternatively, patient and/or physician organisations could incorporate more detailed information and advice on their websites to offer improved support to concerned patients and the various physicians involved in their care during pregnancy. Another key improvement would be increased dialogue, by telephone, letters or email, between the varied physicians involved in an individual patient's care in order to provide coordinated advice and support. Together these measures would aim to improve patient support and satisfaction.

It should be noted that this study does have some limitations. Two important limitations of the patient survey were an absence of formal survey validation and the reliance on self-reporting of diagnosis by patients. It should also be considered that patients who are willing and motivated to complete a questionnaire may differ significantly from the overall patient population. Furthermore, even though the surveys were translated into local languages, differences in terminology and healthcare system structure exist across countries which could impact pooling of results; for example, the terms obstetrician and gynaecologist could be understood as being interchangeable in some countries but distinctly different specialties in others, meaning patient interpretation of the survey could vary. The physician survey may also suffer related issues. In addition, the physician survey was only delivered to gastroenterologists in the USA and did not investigate the activities of these physicians in other countries. The range of experience among physicians was also broad which, although providing good coverage of routine clinical practice, could be complicated by differences in attitudes between physicians of different generations. A limitation of the current study is an inability to tease out any potential influence these factors may have on variation in the results. The netnography research may have been limited by use of keywords common to one country/region but different in others (eg, ‘fertility’ vs ‘infertility’) which could have restricted comprehensive analysis of the online landscape and patient discussions. Finally, this study did not investigate the related concerns of men suffering from inflammatory disease who may be using chronic medication and also considering a family; indeed this population is often understudied and may need improved support.

In summary, FPP are extremely important issues for female patients of childbearing age who live with chronic inflammatory disease. A summary of key considerations, highlighted by the results from the current study, for all physicians involved in the treatment of this often neglected group of patients is presented in figure 5 . It is clear that female patients of childbearing age do wish to discuss these issues with their physicians, although expectations regarding frequency of discussion and their preferred physician for advice vary considerably. Currently it appears that more can be done to provide these patients with consistent and co-ordinated information regarding their disease and how it, and associated treatments, could affect conception or pregnancy. Results from this study suggest physicians should regularly initiate discussion of these topics with their female patients of childbearing age, particularly those on chronic medication or when changes to the treatment plan could impact pregnancy outcome, in order to improve patient support. In addition, greater cross-specialty communication between physicians involved in different aspects of the patient's care, from gastroenterologists and rheumatologists to gynaecologists/obstetricians and GPs, is needed to improve the consistency of advice offered to this often overlooked patient population.

Family planning and pregnancy-related considerations for practicing physicians treating female patients of childbearing age who live with chronic inflammatory disease: key messages from the survey of current clinical practice and patient perceptions.

Acknowledgments

This publication has been funded by UCB Pharma. The authors acknowledge InSites Consulting and ACROSS HEALTH for survey development, management and analysis. The authors also acknowledge Costello Medical Consulting for editorial and administrative support.

Symmons D ,
Carbone LD ,
Michet CJ ,
Gollop JH ,
Phillips SF ,
Melton LJ ,
Loftus EV Jr. .
Lapinski RH ,
Morales M ,
Narendranathan M ,
van Dunne FM ,
Jawaheer D ,
Mayberry JF ,
Weterman IT
Navarro-Llavat M ,
Vermeire S ,
Carbonnel F ,
Coulie PG ,
Mahadevan U ,
Cucchiara S ,
Mahadevan U
Ostensen M ,
Paxton JW ,
Buckley LM ,
Bullaboy CA ,
Leichtman L ,
McElhatton P ,
Chakravarty EF ,
Sanchez-Yamamoto D ,
Langen ES ,
Liaquat M ,
Hameen-Anttila K ,
Peters SL ,
Humphrey JR ,
van der Woude CJ ,
Kolacek S ,
Panchal S ,
Moorthy A ,

Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Files in this Data Supplement:

Data supplement 1 - Online supplement

Contributors EC, MEBC, CG and DSP were involved in substantial contribution to conception and design, interpretation of the data, drafting and critical revision of the manuscript, and final approval of the manuscript for submission. SM was involved in substantial contribution to conception and design, acquisition, analysis and interpretation of the data, critical revision of the manuscript and final approval of the manuscript for submission.

Funding This work was supported by UCB Pharma.

Competing interests EC has previously been reimbursed by UCB Pharma for consultation services; MEBC has previously been reimbursed by UCB Pharma for consultation services; DSP is an employee of UCB Pharma; SM is an employee of UCB Pharma.

Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement No additional data are available.

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Fetal and umbilical Doppler ultrasound in normal pregnancy

Zarko alfirevic.

1 School of Reproductive and Developmental Medicine, Division of Perinatal and Reproductive Medicine, The University of Liverpool, Liverpool, UK.

Tamara Stampalija

2 Department of Obstetrics and Gynaecology, Children’s Hospital “V. Buzzi”, Milano, Italy.

Gillian ML Gyte

3 Cochrane Pregnancy and Childbirth Group, School of Reproductive and Developmental Medicine, Division of Perinatal and Reproductive Medicine, The University of Liverpool, Liverpool, UK

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 8, 2010.

Review content assessed as up-to-date: 30 May 2010.

One of the main aims of routine antenatal care is to identify the ‘at risk’ fetus in order to apply clinical interventions which could result in reduced perinatal morbidity and mortality. Doppler ultrasound study of umbilical artery waveforms helps to identify the compromised fetus in ‘high-risk’ pregnancies and, therefore, deserves assessment as a screening test in ‘low-risk’ pregnancies.

To assess the effects on obstetric practice and pregnancy outcome of routine fetal and umbilical Doppler ultrasound in unselected and low-risk pregnancies.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group Trials Register (May 2010).

Selection criteria

Randomised and quasi-randomised controlled trials of Doppler ultrasound for the investigation of umbilical and fetal vessels waveforms in unselected pregnancies compared to no Doppler ultrasound. Studies where uterine vessels have been assessed together with fetal and umbilical vessels have been included.

Data collection and analysis

Two authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction.

Main results

We included five trials involving 14,185 women. The methodological quality of the trials was generally unclear because of insufficient data included in the reports.

Routine fetal and umbilical Doppler ultrasound examination in low-risk or unselected populations did not result in increased antenatal, obstetric and neonatal interventions, and no overall differences were detected for substantive short term clinical outcomes such as perinatal mortality. There is no available evidence to assess the effect on substantive long term outcomes such as childhood neurodevelopment and no data to assess maternal outcomes, particularly psychological effects.

Authors’ conclusions

Existing evidence does not provide conclusive evidence that the use of routine umbilical artery Doppler ultrasound, or combination of umbilical and uterine artery Doppler ultrasound in low-risk or unselected populations benefits either mother or baby. Future studies should be designed to address small changes in perinatal outcome, and should focus on potentially preventable deaths.

Description of the condition

One of the main aims of routine antenatal care is to identify the ‘at risk’ fetus in order to apply clinical interventions which could result in reduced perinatal morbidity and mortality ( RCOG 1997 ). The routine use of a screening test should be based on proven clinical effectiveness, to avoid subjecting a large group of normal women to anxiety and inappropriate intervention with subsequent risk of iatrogenic morbidity and mortality.

In majority of cases the fetal death can be attributed to a ‘known’ cause such as maternal disorder (hypertension, diabetes and others), fetal pathology (congenital abnormalities, intrauterine growth restrictions (IUGR)), placental pathologies or intrapartum complications. The rate of unexplained fetal deaths decreased from 3.5 per 1000 total births in the 1960s to 1.1 to 1.9 per 1000 in the 1990s ( Chibber 2005 ; Fretts 1992 ; Huang 2000 ). Unrecognised IUGR remains the main cause of unexplained stillbirths in otherwise uncomplicated pregnancy. Two recent studies identified the fetal growth restriction in 43% ( Gardosi 2005 ) and 52% ( Froen 2004 ) of unexplained stillbirth respectively, concluding that the IUGR was the strongest risk factor for an unexplained intrauterine death.

It is important to highlight that the fetal growth restriction is often confused with the concept of being small-for-gestational age. Some fetuses are constitutionally small and they do not have increased perinatal mortality or morbidity. Inability to distinguish easily between small but healthy fetuses and those who are failing to reach their growth potential has hampered attempts to find appropriate treatment for growth restriction ( Soothill 1993 ). Growth restricted fetuses are at increased risk of mortality and morbidity ( Bernstein 2000 ; Fisk 2001 ). The serious morbidity includes intraventricular haemorrhage, bronchopulmonary dysplasia, necrotising enterocolitis, infection, pulmonary haemorrhage, hypothermia and hypoglycaemia ( Fisk 2001 ). Early antenatal detection, treatment where appropriate, and timely delivery could minimise the risks significantly.

Description of the intervention

Doppler ultrasound technology is based on the Doppler shift, a physical principle of the change of ultrasound frequency when aimed at the moving object (e.g. red cell) ( Campbell 1983 ; Fitzgerald 1977 ; Nelson 1988 ; Owen 2001 ). Different Doppler methods are used in obstetrics: continuous-wave, pulsed-wave, colour and power Doppler flow ( Eik-Nes 1980 ; Mires 2000 ).

Doppler ultrasound examination can be performed as a part of a more detailed ultrasound assessment that includes fetal biometry and anatomical survey or as a separate ultrasound examination. Flow of the umbilical and fetal arteries is most often quantified either by pulsatility index or resistant index ( Burns 1993 ; Nelson 1988 ). These indices reflect the down stream vascular resistance by quantifying the differences between the peak systolic and the enddiastolic velocity within blood vessels of interest in each cardiac cycle. A high ratio in umbilical artery indicates a high vascular impedance and possible feto-placental compromise. In extreme circumstance the blood flow at the end of diastole may be absent or even reversed (Figure 2 - we plan to insert a scan picture in a final version).

Initial Doppler studies have been restricted to the umbilical artery, but other fetal vessels have recently become a focus of interest including middle cerebral artery and ductus venosus.

How the intervention might work

Although stillbirths and fetal complications related to placental problems are rare in uncomplicated pregnancy, the impact is devastating. Current methods for the assessment of fetal well-being and detection of compromised fetus in the routine antenatal care include: symphysis fundal height measurement from the 24th week ( Neilson 1998a ; NICE 2008 ), fetal movements charts ( Mangesi 2007 ) and antenatal cardiotocography ( Pattison 1999 ). None of them, however, have proven ability to make an impact on perinatal mortality and morbidity.

Observational and longitudinal studies of Doppler ultrasound in unselected or low-risk pregnancies have raised doubts about its efficacy and authors have cautioned against its introduction into obstetric practice without supportive evidence from randomised trials ( Beattie 1989 ; Goffinet 1997 ; Sijoms 1989 ). The relatively low incidence of preventable adverse perinatal outcomes in low-risk and unselected populations present a challenge in evaluating the clinical effectiveness of routine Doppler ultrasound, as large numbers are required to provide definitive evidence.

Why it is important to do this review

Any screening test has not only potential for benefit, but also for harm ( Barnett 1995 ). Subjecting a large group of low-risk patients to a screening test with relatively high false positive rate is likely to cause anxiety and lead to inappropriate intervention and subsequent risk of iatrogenic morbidity and mortality.

Although the epidemiological studies and Cochrane review have found no correlation between the use of fetal Doppler ultrasound and adverse neurological outcome in childhood development, childhood malignancies and birth weight ( Neilson 1998b ; Salvesen 2007 ), some concern about the association between the left-handedness in males and exposure to Doppler ultrasound has been expressed ( Kieler 2001 ; Kieler 2002 ; Salvesen 1999 ).

Considering that no recent studies have been done regarding the fetal exposure to Doppler ultrasound and the fact that the acoustic output of a modern equipment has increased ( Barnett 2001 ; Duck 1991 ; Henderson 1997 ) indicates that Doppler ultrasound in obstetrics should be used only if of proven value (in terms of improved outcome, good specificity and sensitivity).

The continuous assessment of the evidence to provide the balanced view of effectiveness, safety and cost effectiveness is, therefore, essential. In this review, we will focus on fetal and umbilical Doppler ultrasound in low-risk and unselected pregnancies. There are other reviews on ‘Fetal and umbilical Doppler ultrasound in high-risk pregnancies’ ( Alfirevic 2009 ) and on ‘Utero-placental Doppler ultrasound for improving pregnancy outcome’ (a Cochrane review in progress).

To assess the effects of routine fetal and umbilical Doppler ultrasound, or a combination of uterine Doppler ultrasound and umbilical Doppler ultrasound, in unselected and low-risk pregnancies on obstetric practice and pregnancy.

A low-risk population is defined as a population where those considered at risk have been excluded. Criteria of ‘at risk’ are defined variably and this is taken into consideration.

In the context of this review ‘unselected’ pregnant population refers to a mixture of pregnant women with no identified risk factors and those who may have some risk factors but the trialists have not reported them separately.

Criteria for considering studies for this review

Types of studies.

All randomised controlled trials of routine fetal and umbilical Doppler ultrasound, or a combination of uterine Doppler ultrasound and umbilical Doppler ultrasound, in unselected or low-risk pregnancies. We included quasi-randomised trials, but planned to undertake sensitivity analysis by trial quality. Had we identified studies that were published as conference abstracts only, we would have tried to contact the authors for further details. We would have included them but undertaken sensitivity analyses of trial quality (see Sensitivity analysis ).

Types of participants

Pregnant women in both unselected and low-risk populations.

Types of interventions

Routine Doppler ultrasound of the fetal and umbilical artery circulation in pregnancy in unselected or low-risk populations. We included studies that considered the combination of utero-placental Doppler and fetal or umbilical Doppler in normal pregnancies in this review.

If appropriate, we performed stratified analyses of all outcome measures in the following comparisons:

all routine Doppler versus no Doppler/concealed Doppler examinations (i.e. caregivers not aware of results);
single Doppler measurement versus no Doppler/concealed Doppler examinations;
multiple Doppler measurement versus no Doppler/concealed Doppler examinations.

Types of outcome measures

We have selected outcome measures with the help of a proposed core data set of outcome measures ( Devane 2007 ).

Primary outcomes

Any perinatal death after randomisation.
Serious neonatal morbidity - composite outcome including hypoxic ischaemic encephalopathy, intraventricular haemorrhage, bronchopulmonary dysplasia, necrotising enterocolitis.

Secondary outcomes

Stillbirth.
Neonatal death.
Any potentially preventable perinatal death after randomisation (excluding congenital malformations, chromosomal abnormalities, termination of pregnancy).
Fetal acidosis.
Apgar score less than seven at five minutes.
Caesarean section (both elective and emergency).
Elective caesarean section.
Emergency caesarean section.
Spontaneous vaginal birth.
Operative vaginal birth.
Induction of labour.
Neonatal resuscitation required.
Infant requiring intubation/ventilation.
Neonatal fitting/seizures.
Preterm birth (before 37 completed weeks of pregnancy).
Infant respiratory distress syndrome.
Meconium aspiration.
Neonatal admission to special care or intensive care unit, or both.
Infant birthweight.
Gestational age at birth.
Length of infant hospital stay.
Long-term infant/child neurodevelopmental outcome.
Women’s views of care/satisfaction.

We have reported non-prespecified outcomes if we consider them to be important.

Search methods for identification of studies

Electronic searches.

We have contacted the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group’s Trials Register (May 2010).

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from:

quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
weekly searches of MEDLINE;
handsearches of 30 journals and the proceedings of major conferences;
weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group.

Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords.

Searching other resources

We have looked for additional studies in the reference lists of the studies identified.

We have not applied any language restrictions.

The methodology for data collection and analysis was based on the Cochrane Handbook of Systematic Reviews of Interventions ( Higgins 2009a ).

Selection of studies

Two review authors have independently assessed for inclusion all the potential studies we identified as a result of the search strategy. We have resolved any disagreement through discussion; there was no need to consult the third author.

Data extraction and management

We have designed a form to extract data. Two review authors have extracted the data using the agreed form. We have resolved discrepancies through discussion. We have entered data into Review Manager software ( RevMan 2008 ), and checked for accuracy. We did not contact authors of the included studies for additional information.

Assessment of risk of bias in included studies

Two review authors have independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions ( Higgins 2009a ). We have resolved any disagreement through discussion.

1) Sequence generation (checking for possible selection bias)

We have described the methods used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We have assessed the methods as:

adequate (any truly random process, e.g. random number table; computer random-number generator);
inadequate (any non-random process, e.g. odd or even date of birth; hospital or clinic record number); or

2) Allocation concealment (checking for possible selection bias)

We have described the methods used to conceal the allocation sequence in sufficient detail and determine whether intervention allocation could have been foreseen in advance of, or during, recruitment.

adequate (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
inadequate (open random allocation; alternation; date of birth);

3) Blinding (checking for possible performance bias)

We have described all the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We have also provided any information relating to whether the intended blinding was effective. Where blinding was not possible, we have assessed whether the lack of blinding was likely to have introduced bias. We have assessed blinding separately for different outcomes or classes of outcomes.

adequate, inadequate or unclear for participants;
adequate, inadequate or unclear for personnel;
adequate inadequate or unclear for outcome assessors.

4) Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations)

We have described the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. We have stated whether attrition and exclusions were reported, the numbers (compared with the total randomised participants), reasons for attrition/exclusion where reported, and any re-inclusions in analyses which we undertook.

Had there been loss of data greater than 20% we would have considered whether this missing data might impact on outcomes acknowledging that with long-term follow up, complete data are difficult to attain.

5) Selective reporting bias

We have described how the possibility of selective outcome reporting bias was examined by us and what we found.

adequate (where it is clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported);
inadequate (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);

6) Other sources of bias

We have described any important concerns we have about other possible sources of bias.

We have assessed whether each study was free of other problems that could put it at risk of bias:

7) Overall risk of bias

We have made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Cochrane Handbook of Systematic Reviews of Interventions ( Higgins 2009a ). With reference to (1) to (6) above, we have assessed the likely magnitude and direction of the bias and whether we considered it was likely to impact on the findings. We would have explored the impact of the level of bias through undertaking sensitivity analyses ( see Sensitivity analysis ) but there were insufficient high-quality studies.

Measures of treatment effect

Where there were multiple pregnancies, we have used the number of women who are randomised as the denominator for maternal outcomes, and the number of babies of women who are randomised as the denominator for neonatal outcomes.

We have also used as the denominator the number of babies of women who were randomised even though some babies could not have attained the outcome; for example, if there was a stillbirth then this baby would not have been able to attain the outcome of ‘Admission to special care baby unit’.

None of the studies reported data on twins, with three studies specifically excluding multiple pregnancies ( Davies 1992 ; Mason 1993 ; Whittle 1994 ). We would have contacted a statistician concerning how to deal with the non-independence of this data for multiple pregnancies had it been necessary.

Dichotomous data

For dichotomous data, we have presented results as summary risk ratio with 95% confidence intervals.

Continuous data

For continuous data, we have used the mean difference if outcomes were measured in the same way between trials. We have used the standardised mean difference to combine trials that measure the same outcome, but used different methods.

Unit of analysis issues

If there had been several time points for assessment of an outcome, we would have performed separate analyses. In studies including multiple pregnancies because of non-independence, we would have used cluster trial methods in these situations and consulted a statistician to help with the analyses.

Dealing with missing data

For included studies, we have noted levels of attrition. We have explored the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis.

For all outcomes, we have carried out analyses, as far as possible, on an intention-to-treat basis: i.e. we have attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised, minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We have assessed statistical heterogeneity in each meta-analysis using the T 2 (tau-squared), I 2 and Chi 2 statistics. We have regarded heterogeneity as substantial if T 2 was greater than zero and either I 2 was greater than 30% or there was a low P-value (less than 0.10) in the Chi 2 test for heterogeneity. Where we found heterogeneity and used random-effects, we have reported the average risk ratio, or average mean difference or average standard mean difference.

Assessment of reporting biases

If there had been 10 or more studies in a meta-analysis, we would have investigated reporting biases (such as publication bias) using funnel plots. We would have assessed funnel plot asymmetry visually, and would have used formal tests for funnel plot asymmetry. For continuous outcomes, we would have used the test proposed by Egger 1997 , and for dichotomous outcomes we would have used the tests proposed by Peters 2006 . If we had detected asymmetry by any of these tests or by a visual assessment, we would have performed exploratory analyses to investigate it.

Had there been sufficient studies of high quality we would, where we have suspected reporting bias ( see ‘Selective reporting bias’ above), have attempted to contact study authors asking them to provide missing outcome data. Where this was not possible, and the missing data were thought to introduce serious bias, we have explored the impact of including such studies in the overall assessment of results by a sensitivity analysis.

Data synthesis

We have carried out statistical analysis using the Review Manager software ( RevMan 2008 ). We have used fixed-effect meta-analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect: i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar. If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we have used random-effects analysis to produce an overall summary, if this was considered clinically meaningful. If an average treatment effect across trials was not clinically meaningful, we have not combined heterogeneous trials. If we used random-effects analyses, the results have been presented as the average treatment effect and its 95% confidence interval, the 95% prediction interval for the underlying treatment effect, and the estimates of T 2 and I 2 ( Higgins 2009b ).

Subgroup analysis and investigation of heterogeneity

We planned to carry out the following a priori subgroup analyses on all outcomes:

umbilical Doppler ultrasound only or umbilical and uteroplacental Doppler ultrasound.

For fixed-effect meta-analyses, we would have conducted the planned subgroup analyses classifying whole trials by interaction tests as described by Deeks 2001 . For random-effects meta-analyses, we would have assessed differences between subgroups by inspection of the subgroups’ confidence intervals; non-overlapping confidence intervals indicate a statistically significant difference in treatment effect between the subgroups.

Sensitivity analysis

We were to carry out sensitivity analysis to explore the effect of trial quality for the primary outcomes in the review; however, there was only one study ( Whittle 1994 ) of sufficient quality in terms of low risk of bias for sequence generation and concealment allocation although it did suffer from other potential bias ( Figure 1 ). Where there was risk of bias associated with a particular aspect of study quality (e.g. inadequate allocation concealment), we were to explore this by sensitivity analysis.

An external file that holds a picture, illustration, etc.
Object name is emss-57120-f0001.jpg

Methodological quality summary: review authors’ judgements about each methodological quality item for each included study.

Publication bias

An assessment of publication bias was desired but considered inappropriate here as only five studies were identified, and it is generally recommended that 10 studies are required for publication bias assessments.

Description of studies

See: Characteristics of included studies ; Characteristics of excluded studies .

Results of the search

The search identified 20 publications, of which we have included five studies involving 14,185 women and 26 meta-analyses. We have excluded eight studies. For further details of trial characteristics, please refer to the tables of Characteristics of included studies and Characteristics of excluded studies .

Included studies

The five included studies were all undertaken in the 1990s. Three studies used fetal/umbilical vessels only ( French Doppler 1997 ; Mason 1993 ; Whittle 1994 ). Two studies used both uterine vessels and umbilical vessels ( Davies 1992 ; Newnham 1993 ). One study looked at a single assessment at 28 to 34 weeks ( French Doppler 1997 ), three studies looked more than one assessment ( Davies 1992 ; Mason 1993 ; Newnham 1993 ) and one study had a mixture of some women receiving a single assessment and others more than one assessment ( Whittle 1994 ).

Excluded studies

We excluded five studies because they studied uterine Doppler ultrasound only and not fetal and umbilical Doppler or a combination of uterine plus fetal and umbilical Doppler ( Ellwood 1997 ; Goffinet 2001 ; Snaith 2006 ; Subtil 2000 ; Subtil 2003 ). These studies will be assessed in a separate review on ‘Utero-placental Doppler ultrasound for improving pregnancy outcome’. We excluded two studies because the previous review authors had tried to contact these authors for information needed for studies to be included and had received no response ( Gonsoulin 1991 ; Schneider 1992 ). We excluded one study because it had high risk of bias; we needed further information before being able to include it and it only reported one outcome relevant to the review (induction of labour) ( Scholler 1993 ).

Risk of bias in included studies

We assessed risk of bias of each included study according to the Cochrane Handbook of Systematic Reviews of Interventions ( Higgins 2009a ) and summarised in Figure 1 .

Only one study had adequate sequence generation and allocation concealment ( Whittle 1994 ), although the imbalance between the number of women allocated to the two groups (1642 to the intervention group and 1344 to the control group) would suggest a problem with the randomisation process. Two studies had adequate sequence generation but unclear allocation concealment ( Mason 1993 ; Newnham 1993 ) and two studies had unclear sequence generation and allocation concealment ( Davies 1992 ; French Doppler 1997 ).

None of the studies could be blinded for clinicians and only ones that had concealed versus revealed groups could be blinded for the women.

Incomplete outcome data

Four studies showed minimal loss of data either by withdrawal after randomisation or by loss to follow up less than 6% ( Davies 1992 ; French Doppler 1997 ; Mason 1993 ; Newnham 1993 ). The fifth study reported no loss of outcome data ( Whittle 1994 ).

Selective reporting

Since we did not assess the trial protocols of the included studies, we cannot comment on whether all the pre-specified outcomes are reported on.

Other potential sources of bias

Three studies appeared to be free from other potential biases ( Davies 1992 ; French Doppler 1997 ; Newnham 1993 ) and for one study this seemed unclear ( Mason 1993 ). The fifth study was assessed as having high risk of bias in that there was a considerable difference in the numbers of women allocated to the two groups (1642 and 1344) which probably indicates a problem with the randomisation ( Whittle 1994 ). This was discussed and explained by the authors as “…due to secretarial error in preparation of the envelopes…previously used random numbers had been ‘recycled’ through the study.” This was considered to be a possible high risk of bias in this study.

Effects of interventions

1) all routine doppler ultrasound versus no doppler ultrasound (five studies, 14,185 women).

Five studies addressed this comparison ( Davies 1992 ; French Doppler 1997 ; Mason 1993 ; Newnham 1993 ; Whittle 1994 ).

1) Any perinatal death after randomisation

Due to the large heterogeneity for this outcome (Tau 2 = 0.18, Chi 2 P = 0.10, I 2 = 51%; ), we used a random-effects meta-analysis. The average risk ratio (RR) across studies was 0.85 (95% confidence interval (CI) 0.47 to 1.54; four studies, 11,190 women, Analysis 1.1), indicating that on average there is no statistically significant reduction identified in the risk of perinatal death when Doppler ultrasound is used. A prediction interval for the underlying relative risk in any future study is also very wide (95% prediction interval = 0.09 to 8.01), reflecting the large heterogeneity identified and the small number of studies.

Based on a single study, there was no significant difference identified in serious neonatal morbidity (RR 0.99, 95% CI 0.06 to 15.75; one study, 2016 woman, Analysis 1.2).

We found no significant differences in either the average intervention effect estimate across studies where a random-effects meta-analysis was used, nor in the pooled estimate of the intervention effect from a fixed-effect meta-analysis for the whole range of the secondary outcomes (Analyses 1.3 to 1.21). These included Apgar scores less than seven at five minutes, caesarean section, operative vaginal births, spontaneous vaginal births, induction of labour, neonatal resuscitation and preterm birth.

When looking further into outcomes with substantive heterogeneity, we found the following.

Stillbirths: there was no evidence of between-study heterogeneity (Tau 2 = 0). Overall, no effect was discernable (Analysis 1.3).
Neonatal death: there was only one study assessing fetal vessels only, showing no statistically significant difference ( French Doppler 1997 ) and two studies using a combination of fetal and utero-placental Doppler ( Davies 1992 ; Newnham 1993 ) showing large heterogeneity (Analysis 1.4).
Potentially preventable neonatal deaths: there was extremely large heterogeneity for this outcome and the average intervention effect across studies from a random-effects meta-analysis was not significant (average RR 0.82, 95% CI 0.15 to 4.67; three studies, 9395 babies, random effects (Tau 2 = 1.87, Chi 2 P < 0.01, I 2 = 80%), Analysis 1.5). This was despite one subgroup appearing to make a difference.

In subgroup analysis with two studies that assessed Doppler ultrasound used only in fetal/umbilical vessels, the heterogeneity disappeared and, in a fixed-effect meta-analysis, there was a statistically significant reduction potentially preventable perinatal deaths (pooled RR 0.35, 95% CI 0.12 to 0.99; two studies, 6884 women, Analysis 1.5.1).

By contrast, in the one study that used a combination of fetal/umbilical vessels and uterine vessels Doppler assessment there was a statistically significant increase potentially preventable perinatal mortality (RR 3.95, 95% CI 1.32 to 11.77; one study, 2475 women, Analysis 1.5.2). Again, caution is strongly advised here as these are subgroup analyses of secondary outcomes containing small number of studies.

Preterm birth: the subgroup analysis failed to provide an explanation of significant heterogeneity for this outcome. (Analysis 1.17).

2) Single Doppler ultrasound assessment versus no Doppler ultrasound (one study, 3898 women)

One study addressed this comparison ( French Doppler 1997 ).

Based on a single study, there was no statistically significant difference identified in any perinatal death after randomisation (RR 0.33, 95% CI 0.09 to 1.23; one study, 3898 women, Analysis 2.1). Serious neonatal morbidity was not assessed.

There were no statistically significant differences identified in any of the secondary outcomes which were assessed (Graphs 2.3 to 2.21).

3) Multiple Doppler ultrasound assessments versus no Doppler ultrasound (three studies, 7301 women)

Three studies addressed this comparison ( Davies 1992 ; Mason 1993 ; Newnham 1993 ). One study combined the data from women having one assessment and some having more than one assessment ( Whittle 1994 ); these data are only included in Comparison 1 - ‘All routine Doppler ultrasound versus no Doppler routine ultrasound’.

Perinatal deaths showed large heterogeneity (Tau 2 = 0.13, Chi 2 P = 0.14, I 2 = 49%). A random-effects meta-analysis showed that the average intervention effect across studies was not statistically significant (average RR 1.00, 95% CI: 0.55 to 1.80; three studies, 7292 women, Analysis 3.1); the prediction interval for the intervention effect in any future study was an even wider 95% CI. From a single study, for the serious neonatal morbidity outcome the intervention effect was again clearly not significant (RR 0.99, 95% CI 0.06 to 15.75; one study, 2016 women, Analysis 3.2) ( Mason 1993 ).

There were no statistically significant differences identified in any of the secondary outcomes which were assessed (Analyses 3.3 to 3.21).

This review includes data from 14,185 women from five studies ( Davies 1992 ; French Doppler 1997 ; Mason 1993 ; Newnham 1993 ; Whittle 1994 ). No differences in perinatal mortality were demonstrated, although there was considerable heterogeneity and the number of participants remains too small to detect small but potentially significant changes in perinatal outcome ( Chalmers 1989 ).

The pooled data from two studies using umbilical artery Doppler showed a significant reduction in potentially preventable perinatal mortality ( French Doppler 1997 ; Whittle 1994 ). However, the results from Davies suggested that routine Doppler ultrasound in unselected pregnancies assessing both umbilical and uterine artery Doppler may do more harm than good, but authors acknowledged that increase in perinatal deaths was an unexpected finding which may have occurred by chance ( Davies 1992 ). Furthermore, they state that the study was not designed to test the ability of routine Doppler ultrasound examinations to reduce perinatal mortality, as a much larger number of women would need to be included in a such a trial to test this hypothesis.

In the Perth study ( Newnham 1993 ), there was an unexpected finding of a greater risk of intrauterine growth restriction in the serial ultrasound and Doppler examination group (i.e. the intensive monitoring group). The authors report “A written diagnosis of intrauterine growth restriction was observed more frequently in the medical records of women in the intensive group than in the regular group (relative risk 2.07; 95% CI 1.34 to 3.21)” but they do not provide data in a format in which we can include in our review (we have written to the authors and Lancet to try to obtain this data). The authors state that multiple logistic regression analyses indicated that this was probably not a chance effect, and it is possible that frequent exposure to ultrasound may have influenced fetal growth. This finding was not associated with increased perinatal morbidity and mortality, and follow up of these children at one year of age found that the difference in growth was no longer discernible ( Newnham 1996 ). This is, however, a further finding which suggests more harm than good, and the authors stress the need for further investigation of the effects of frequent ultrasound exposure on fetal growth.

AUTHORS’ CONCLUSIONS

Implications for practice.

Existing data do not provide conclusive evidence that the use of routine umbilical artery Doppler ultrasound, or combination of umbilical and uterine artery Doppler ultrasound in low-risk or unselected populations benefits either mother or baby. At present, Doppler ultrasound examination should be reserved for use in high-risk pregnancies ( Alfirevic 2009 ).

Implications for research

If there is to be future research into fetal and umbilical Doppler ultrasound examination in low-risk or unselected populations, a large trial with adequate power to test hypotheses related to perinatal outcome is required. Trials should focus on potentially preventable deaths and inclusion criteria should reflect that. It would be also important to include assessment of neurodevelopment assessment of maternal outcomes and psychological effects on mother.

PLAIN LANGUAGE SUMMARY

Doppler ultrasound of fetal blood vessels in normal pregnancies.

One of the main aims of routine antenatal care is to identify babies who are not thriving in the womb. It is possible that medical interventions might improve outcomes for these babies, if they can be identified. Doppler ultrasound uses sound waves to detect the movement of blood in vessels. It is used in pregnancy to study blood circulation in the baby, uterus and placenta. Using it in high-risk pregnancies, where there is concern about baby’s condition, shows benefits. However, its value as a screening tool in all pregnancies needs to be assessed as there is a possibility of unnecessary interventions and adverse effects. The review of trials of routine Doppler ultrasound of the baby’s vessels in pregnancy identified five studies involving more than 14,000 women and babies. The studies were not of high quality and were all undertaken in the 1990s. There were no improvements identified for either the baby or the mother, though more data would be needed to prove whether it is effective or not for improving outcomes.

ACKNOWLEDGEMENTS

We are grateful to Professor AM Weindling (Professor of Perinatal Medicine, University of Liverpool) for advice on neonatal outcomes to the authors of the original version of this review ( Bricker 2007 ). Also to Dr JA Davies, and to Professor J Newnham and Dr Sharon Evans for also providing further information on their trials ( Davies 1992 ; Newnham 1993 ) to the authors of the original version of this review ( Bricker 2007 ).

Our thanks to Leanne Bricker and James P Neilson for their work on the previous version of this review.

Richard Riley who provided help with the statistical analysis, in particular with the random-effects analyses and prediction intervals.

SOURCES OF SUPPORT

Internal sources

The University of Liverpool, UK.

External sources

National Institute for Health Research, UK.

NIHR NHS Cochrane Collaboration Programme Grant Scheme award for NHS-prioritised centrally-managed, pregnancy and childbirth systematic reviews: CPGS02

CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study id].

Davies 1992

French Doppler 1997

Newnham 1993

Whittle 1994

AN: antenatal

BP: blood pressure

CTG: cardiotocography

ITT: intention to treat

IUGR: intrauterine growth restriction

NICU: neonatal intensive care unit

PIH: pregnancy-induced hypertension

PNM: perinatal mortality

SCBU: special care baby unit

SGA: small-for-gestational age

US: ultrasound

Characteristics of excluded studies [ordered by study ID]

RCT: randomised controlled trial

DATA AND ANALYSES

Comparison 1.

All routine Doppler ultrasound versus no Doppler ultrasound

Comparison 2

Single Doppler ultrasound assessment versus no Doppler ultrasound

Comparison 3

Multiple Doppler ultrasound assessments versus no Doppler ultrasound

Protocol first published: Issue 2, 1999

Review first published: Issue 2, 2000

DIFFERENCES BETWEEN PROTOCOL AND REVIEW

We updated the Background and Methods sections and changed the title from ‘Routine Doppler ultrasound in normal pregnancy’ to ‘Fetal and umbilical Doppler ultrasound in normal pregnancy’.

We changed the outcome of ‘Preterm labour (onset of labour before 37 weeks)’ to ‘Preterm birth (birth less than 37 weeks)’ because this was the outcome reported in the studies.

We have modified the wording in the methods sections for Assessment of heterogeneity , Assessment of reporting biases and Data synthesis to update them with the new methods being used by the group, developed in conjunction with the group’s statisticians, Simon Gates and Richard Riley. We have used these new methods in the review.

WHAT’S NEW

Last assessed as up-to-date: 30 May 2010.

DECLARATIONS OF INTEREST None known.

References to studies included in this review

References to studies excluded from this review, additional references, references to other published versions of this review.

DAVID S. GREGORY, MD, VELYN WU, MD, AND PREYASHA TULADHAR, MD

This is a corrected version of the article that appeared in print.

Am Fam Physician. 2018;98(9):595-602

Author disclosure: No relevant financial affiliations.

Women often see their primary care physicians for common acute conditions during pregnancy. These conditions may be caused by pregnancy (obstetric problems) or worsened by pregnancy (obstetrically aggravated problems), or they may require special consideration during pregnancy because of maternal or fetal risks (nonobstetric problems). Primary care physicians should know the differential diagnosis for common conditions during pregnancy and recognize the important findings of obstetric and urgent nonobstetric problems. The family physician can evaluate and treat most nonobstetric problems, although obstetric problems require referral to a primary maternity care clinician. A tiered approach, including routinely looking for all-cause red flag symptoms and signs, while remaining aware of estimated gestational age, allows for high-quality care and shared decision making between the family physician and the pregnant patient. When treating common causes of nausea and epigastric pain/gastroesophageal reflux, lifestyle modifications are considered the safest and first-choice therapy, followed by well-established low-risk therapies, such as vitamin B 6 (pyridoxine) and doxylamine for nausea, and antacids not containing salicylates (found in bismuth combination products) for gastroesophageal reflux. Other common conditions during pregnancy are best treated with low-risk therapies, such as using antihistamines or topical steroids for rashes, first-generation cephalosporins or amoxicillin for cystitis, and physical therapy and acetaminophen for low back pain and headaches.

Women often see their primary care physicians for common acute conditions during pregnancy, even if they are not the primary maternity care clinician. Some conditions are caused directly by pregnancy (obstetric problems) or are worsened by pregnancy (obstetrically aggravated problems), and others require special consideration during pregnancy because of maternal or fetal risks (nonobstetric problems). 1 Table 1 outlines the causes of common symptoms during pregnancy.

General Considerations for Pregnant Patients

To ensure appropriate evaluation and treatment, an accurate calculation of the estimated gestational age is essential. Some symptoms are trimester-specific, whereas others (e.g., abdominal pain, vaginal bleeding) may present throughout the pregnancy ( Table 2 ) . Symptoms and signs may vary in importance depending on whether they are caused by pregnancy or are simply common acute findings that may be unrelated to the pregnancy.

Physiologic changes in pregnancy lead to predictable problems that may impact the patient's function and health, such as musculoskeletal aches and pains, nasal congestion, and nausea. Given the potential risks of some treatments to the fetus, as well as possible maternal adverse effects, the decision of whether and how to treat is based on benefits vs. potential harms. 2

The U.S. Food and Drug Administration's new labeling system for safety of medications during pregnancy and breastfeeding no longer uses alphabetical ratings (A, B, C, D, and X) and provides more guidance on risks, including information based on gestational age and lactation and reproductive risks. 3 , 4 After identifying the risks and benefits of treatments, family physicians can engage in shared decision making with their pregnant patients. Table 3 summarizes the evaluation and treatment of common symptoms during pregnancy. 5 – 42

Common Symptoms During Pregnancy

Nausea and vomiting.

About one-half of pregnant women have nausea and vomiting during pregnancy. 43 Nausea and vomiting in pregnancy increases the risk of dehydration, poor function, poor weight gain, and, if severe, acute renal failure and impaired fetal growth. Benign nausea and vomiting of pregnancy is the most common obstetric cause and tends to begin by four weeks estimated gestational age and resolve by the end of 12 weeks estimated gestational age. 5 If it begins or ends outside of these intervals or is severe or refractory, less common obstetric causes (e.g., multiple gestation, molar pregnancy) and nonobstetric causes (e.g., gallbladder problems, thyroid disease) should be considered. 6

Despite increased availability of prescription therapies for nausea in pregnancy, not all women require prescription antiemetics, and the safety of these therapies is not as clear as conservative treatments. 7 , 8 First-line treatments include low-risk lifestyle modifications, such as eating frequent small meals throughout the day to keep the stomach from becoming too empty or full, and avoiding foods that further slow gastric emptying (high-protein or fatty foods) or have intense smells or tastes. 7 , 8 If these conservative approaches are ineffective, other therapies, including vitamin B 6 (pyridoxine), over-the-counter antihistamines such as doxylamine, and natural ginger (less than 1,500 mg per day), can be added in a stepwise fashion. 7 , 9 , 10 There is weak evidence that P6 acupressure can also be a treatment option 7 (a video of this therapy is available at https://www.mskcc.org/cancer-care/patient-education/acupressure-nausea-and-vomiting ). [corrected]

Combination doxylamine 10 mg/pyridoxine 10 mg (Diclegis) is approved by the U.S. Food and Drug Administration for the prevention of nausea and vomiting in pregnancy. The combination may improve compliance because it includes fewer pills but can also be much more expensive than each medication alone.

Prescribed antiemetics such as metoclopramide (Reglan) and trimethobenzamide (Tigan) are reserved for severe or refractory cases. 9 , 10 However, there are safety concerns with some prescribed antiemetics, such as promethazine, which has a risk of neonatal respiratory depression near term or during labor, and ondansetron (Zofran), which physicians should consider avoiding in the first trimester because of conflicting data on the risk of teratogenicity. 9 – 11

EPIGASTRIC PAIN/GASTROESOPHAGEAL REFLUX

Gastroesophageal reflux disease is common in pregnancy and is attributed to progesterone-mediated relaxation of the lower esophageal sphincter, which increases the frequency and severity of gastric reflux. Other conditions that present as heartburn-like discomfort during pregnancy include peptic ulcer disease, preeclampsia (i.e., HELLP [hemolysis, elevated liver enzymes, and low platelet count] syndrome), 12 cholecystitis, and acute fatty liver of pregnancy.

If the discomfort is atypical for reflux, persistent, or severe, or if it begins after 20 weeks estimated gestational age in combination with other concerning symptoms ( Table 3 5 – 42 ) , the patient should be evaluated for conditions other than reflux.

An elevated alkaline phosphatase level is normal during pregnancy. However, an elevated lipase, bilirubin, or transaminase level requires ultrasound evaluation for cholecystitis, especially in the presence of severe colicky abdominal pain or other suggestive findings (e.g., positive Murphy sign, leukocytosis, fever). Peptic ulcer disease should be considered if results of laboratory tests such as complete blood count, liver panel, and lipase level are normal and reflux therapies are ineffective.

No one therapy for gastroesophageal reflux has been proven superior; therefore, prioritizing therapy depends on relative risks and adverse effects. 13 Initial therapies for gastroesophageal reflux of pregnancy include low-risk lifestyle interventions such as eating frequent small meals and avoiding smoking, caffeine, peppermint, and chocolate. Next choices generally include over-the-counter antacids that do not contain salicylates (found in bismuth combination products) and over-the-counter cimetidine (Tagamet), famotidine (Pepcid), or ranitidine (Zantac). Proton pump inhibitors are reserved for severe or refractory cases because of cautions advised during pregnancy and should be considered only in consultation with a primary maternity care clinician. 14 – 16 Whatever the suspected cause, an esophagogastroduodenoscopy should be performed only for serious indications, such as significant gastrointestinal bleeding, and is safer in the second trimester compared with the first. 44

Apart from physiologic rhinitis of pregnancy, upper respiratory tract conditions are not usually caused by the normal hormonal, anatomic, and circulatory effects of pregnancy. 45 In patients with preexisting chronic conditions, such as asthma, management of the condition is similar during pregnancy, although therapies can be adjusted based on safety data. 46 , 47 Evaluation of acute cough should consider acute asthma exacerbation, allergic reaction, and viral and bacterial infections. 17 Although cough alone is not indicative of pulmonary embolism, because of the increased risk of pulmonary embolism in pregnancy, the condition should be considered whenever cough is associated with chest pain or shortness of breath.

Common symptoms associated with cough include nasal congestion, rhinorrhea, pharyngitis, shortness of breath, and chest discomfort. In the absence of a concerning diagnosis, the symptoms can be treated with the usual prescription and over-the-counter therapies. 20 , 21 Prevention of upper respiratory tract illnesses through hand/cough hygiene and the inactivated influenza and Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccines is essential. Although a case-control study found a possible relationship between the influenza vaccine and miscarriage in a subset of patients, current evidence supports the safety of the vaccine in pregnancy. 18 , 19

Skin conditions that arise or worsen during pregnancy can be due to hormonal and other physiologic changes of pregnancy. 48 , 49 Most of these conditions do not impact pregnancy outcomes. 50 , 51 Benign skin conditions of pregnancy include melasma ( eFigure A ) and striae gravidarum ( eFigure B ) . Signs and symptoms of dermatoses in pregnancy include pruritus, papules, and plaques. Notably, pruritic urticarial papules and plaques of pregnancy spare the umbilicus ( eFigure C ) . Treatment of skin conditions in pregnancy typically involves antihistamines, topical steroids, or oral steroid tapers. 22 – 27

Intrahepatic cholestasis of pregnancy, which causes pruritus without a rash, has been associated with increased fetal mortality, warranting antenatal surveillance in consultation with a primary maternity care clinician. Intrahepatic cholestasis of pregnancy is treated with ursodiol (Actigall) in consultation with a primary maternity care clinician, although the therapy leads to only slightly better fetal and maternal outcomes than placebo. Cholestyramine (Questran) has been used, but it only reduces pruritus. 28 Delivery by 35 to 37 weeks estimated gestational age may be warranted if bile acid levels are more than 16.3 mcg per mL (40 μmol per L). 29

Although frequency and urgency are normal as the uterus enlarges in the later stages of pregnancy, dysuria may be a result of cystitis, pyelonephritis, or sexually transmitted infections, which can lead to maternal and fetal morbidity. 30 , 31 In pregnant women who have more than 100,000 colony-forming units of one bacterial species on urine culture, starting antibiotics early is necessary to reduce the risk of pyelonephritis, even in those who are asymptomatic. 32 – 34

The choice of an appropriate oral antibiotic (e.g., penicillins, such as amoxicillin; first-generation cephalosporins; erythromycin; nitrofurantoin) is based on known drug risks during pregnancy, patient drug allergies, and bacterial resistance patterns. 35 Nitrofurantoin is not used at term because of the risk of severe hemolytic anemia following birth. Trimethoprim/sulfamethoxazole is generally not recommended for use in pregnancy because of risks of neural tube defects in early pregnancy, as well as kernicterus in the newborn and permanent neonatal neurologic damage. [corrected] A systematic review found that of the nonantibiotic measures taken to prevent urinary tract infections during pregnancy, only genital hygiene can be recommended in practice. 52

Because bacteriuria increases the risk of preterm labor, urinary cultures should be checked after treatment for asymptomatic bacteriuria, cystitis, or pyelonephritis to ensure bacteriuria resolves and does not recur. A follow-up urinary culture should be performed for test of cure. It is prudent to repeat follow-up cultures periodically.

LOW BACK PAIN

Low back pain often occurs during pregnancy because of musculoskeletal strain from increased lordosis and soft tissue laxity. However, urologic and neurologic red flags ( Table 1 ) should be identified and treated. Acute low back pain should be more rigorously evaluated when associated with a history of trauma, vaginal bleeding, severe abdominal pain, loss of fluid, uterine contractions, uterine tenderness, change in fetal movement, or urinary tract symptoms. This evaluation (in consultation with a primary maternity care clinician) should be focused on ruling out obstetric complications of trauma, such as abruption, combined with systematic monitoring for uterine contractions and fetal heart rate, and possibly fetal ultrasonography. 36

Treatment of back pain in pregnant women targets alleviating musculoskeletal strain with exercises and physical therapy. Additional therapy such as acetaminophen, acupuncture, support devices, warm baths, or epidural steroids may be needed. 36 , 37 A systematic review found that osteopathic manipulative treatment may improve function and reduce pelvic girdle and low back pain during and after pregnancy. 53

New-onset headaches or a new type of headache in pregnancy warrants further evaluation to distinguish urgent or emergent causes (e.g., meningitis, subarachnoid hemorrhage) from common preexisting conditions (e.g., sinusitis, tension or migraine headaches). 38 , 40 , 42 Preeclampsia must be ruled out in all pregnant women with headache who are more than 20 weeks' gestation by monitoring serial blood pressures and assessing urine for protein in consultation with a primary maternity care clinician. 40 , 42

Tension and migraine headaches can lead to significant morbidity. 42 Acetaminophen is an initial, low-risk therapy. Other drugs such as sumatriptan (Imitrex), dexamethasone (brief, isolated use; avoid during the first trimester), and ketorolac (second trimester only) can be used with caution, after the potential risks are explained to the patient, for severe or refractory headaches that significantly affect the patient's nutrition, hydration, or functioning. When headaches are associated with sudden onset, focal neurologic symptoms and findings, fever, or neck stiffness, further emergent workup, initially with shielded head computed tomography and possibly lumbar puncture, is warranted. 39 – 41

Data Sources: The authors searched the Cochrane database, National Guideline Clearinghouse, UpToDate, and Ovid/PubMed, as well as references within these sources. Key words included pregnancy, rash, skin, asthma, upper respiratory infection, infection, nonobstetric complaints, nausea, dyspepsia, heartburn, low back pain, headache, urinary tract infection, back pain, and lumbar pain. Search dates: March 1 to November 7, 2016, and June 19 to July 3, 2018.

Coco A. How often do physicians address other medical problems while providing prenatal care?. Ann Fam Med. 2009;7(2):134-138.

Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976–2008. Am J Obstet Gynecol. 2011;205(1):51.e1-51.e8.

Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation . 11th ed. Philadelphia, Pa.: Lippincott Williams and Wilkins; 2017.

U.S. Department of Health and Human Services. Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products—content and format. Guidance for industry. June 2015. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450636.pdf . Accessed May 22, 2018.

Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy [published correction appears in Br J Gen Pract . 1993;43(373):325]. Br J Gen Pract. 1993;43(371):245-248.

Zielinski R, Searing K, Deibel M. Gastrointestinal distress in pregnancy. J Perinat Neonatal Nurs. 2015;29(1):23-31.

Matthews A, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015(9):CD007575.

Boelig RC, Barton SJ, Saccone G, et al. Interventions for treating hyper-emesis gravidarum. Cochrane Database Syst Rev. 2016(5):CD010607.

Herrell HE. Nausea and vomiting of pregnancy. Am Fam Physician. 2014;89(12):965-970.

McParlin C, O'Donnell A, Robson SC, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy. JAMA. 2016;316(13):1392-1401.

Lavecchia M, Chari R, et al. Ondansetron in pregnancy and the risk of congenital malformations. J Obstet Gynaecol Can. 2018;40(7):910-918.

American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.

Phupong V, Hanprasertpong T. Interventions for heartburn in pregnancy. Cochrane Database Syst Rev. 2015(9):CD011379.

Pasternak B, Hviid A. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med. 2010;363(22):2114-2123.

Gerson LB. Treatment of gastroesophageal reflux disease during pregnancy. Gastroenterol Hepatol (N.Y.). 2012;8(11):763-764.

Gill SK, O'Brien L, et al. The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis. Am J Gastroenterol. 2009;104(6):1541-1545.

Hameed AB. Cardiac and pulmonary disorders in pregnancy. In: DeCherney AH, ed. Current Diagnosis and Treatment: Obstetrics and Gynecology . 11th ed. New York, NY: McGraw-Hill/Medical; 2013.

Donahue JG, Kieke BA, King JP, et al. Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010–11 and 2011–12. Vaccine. 2017;35(40):5314-5322.

Meijer WJ, van Noortwijk AG, Bruinse HW, et al. Influenza virus infection in pregnancy. Acta Obstet Gynecol Scand. 2015;94(8):797-819.

Laibl V, Sheffield J. The management of respiratory infections during pregnancy. Immunol Allergy Clin North Am. 2006;26(1):155-172.

Servey J, Chang J. Over-the-counter medications in pregnancy [published correction appears in Am Fam Physician . 2015;92(5):332]. Am Fam Physician. 2014;90(8):548-555.

Tunzi M, Gray GR. Common skin conditions during pregnancy. Am Fam Physician. 2007;75(2):211-218.

Stephenson-Famy A, Gardella C. Herpes simplex virus infection during pregnancy. Obstet Gynecol Clin North Am. 2014;41(4):601-614.

DiCarlo A, Amon E, et al. Eczema herpeticum in pregnancy and neonatal herpes infection. Obstet Gynecol. 2008;112(2 pt 2):455-457.

Müllegger RR, Häring NS, Glatz M. Skin infections in pregnancy. Clin Dermatol. 2016;34(3):368-377.

Tyler KH. Dermatologic therapy in pregnancy. Clin Obstet Gynecol. 2015;58(1):112-118.

Danesh M, Pomeranz MK, McMeniman E, Murase JE. Dermatoses of pregnancy. Clin Dermatol. 2016;34(3):314-319.

Reyes H, Sjövall J. Bile acids and progesterone metabolites in intrahepatic cholestasis of pregnancy. Ann Med. 2000;32(2):94-106.

Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes. Hepatology. 2014;59(4):1482-1491.

Smaill FM, Vazquez JC. Antibiotics for asymptomatic bacteriuria in pregnancy. Cochrane Database Syst Rev. 2015(8):CD000490.

Mittendorf R, Williams MA, Kass EH. Prevention of preterm delivery and low birth weight associated with asymptomatic bacteriuria. Clin Infect Dis. 1992;14(4):927-932.

Widmer M, Lopez I, et al. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. 2015(11):CD000491.

Vazquez JC, Abalos E. Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database Syst Rev. 2011(1):CD002256.

Schneeberger C, Geerlings SE, Middleton P, Crowther CA. Interventions for preventing recurrent urinary tract infection during pregnancy. Cochrane Database Syst Rev. 2015(7):CD009279.

Delzell JE, LeFevre ML. Urinary tract infections during pregnancy [published correction appears in Am Fam Physician . 2000;61(12): 3567]. Am Fam Physician. 2000;61(3):713-721.

Sabino J, Grauer JN. Pregnancy and low back pain. Curr Rev Musculoskelet Med. 2008;1(2):137-141.

Liddle S, et al. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015(9):CD001139.

Sperling J, Dahlke JD, Huber WJ, Sibai BM. The role of headache in the classification and management of hypertensive disorders in pregnancy. Obstet Gynecol. 2015;126(2):297-302.

Schoen JC, Campbell RL, Sadosty AT. Headache in pregnancy. West J Emerg Med. 2015;16(2):291-301.

Ramchandren S, Cross BJ, Liebeskind DS. Emergent headaches during pregnancy: correlation between neurologic examination and neuroimaging. AJNR Am J Neuroradiol. 2007;28(6):1085-1087.

Raffaelli B, Siebert E, Körner J, et al. Characteristics and diagnoses of acute headache in pregnant women. J Headache Pain. 2017;18(1):114.

Robbins M, Farmakidis C, Dayal AK, Lipton RB. Acute headache diagnosis in pregnant women. Neurology. 2015;85(12):1024-1030.

ACOG. Practice bulletin 189. Nausea and vomiting of pregnancy. 2018.

Shergill AK, Ben-Menachem T, et al. Guidelines for endoscopy in pregnant and lactating women [published correction appears in Gastrointest Endosc . 2013;77(5):833]. Gastrointest Endosc. 2012;76(1):18-24.

Hegewald MJ, Crapo RO. Respiratory physiology in pregnancy. Clin Chest Med. 2011;32(1):1-13.

Kelly W, Massoumi A, Lazarus A. Asthma in pregnancy: physiology, diagnosis, and management. Postgrad Med. 2015;127(4):349-358.

Vanders RL, Murphy VE. Maternal complications and the management of asthma in pregnancy. Womens Health (Lond). 2015;11(2):183-191.

Vora RV, Gupta R, Mehta MJ, et al. Pregnancy and skin. J Family Med Prim Care. 2014;3(4):318-324.

Winkel AF. Dermatologic disorders in pregnancy. In: DeCherney AH, ed. Current Diagnosis and Treatment: Obstetrics and Gynecology . 11th ed. New York, NY: McGraw-Hill/Medical; 2013.

Elston CA, Elston DM. Treatment of common skin infections and infestations during pregnancy. Dermatol Ther. 2013;26(4):312-320.

Adler H, Lambert JS. Clinical focus: infections in pregnancy. Hosp Pract (1995). 2014;42(2):108-124.

Ghouri F, Hollywood A, Ryan K. A systematic review of non-antibiotic measures for the prevention of urinary tract infections in pregnancy. BMC Pregnancy Childbirth. 2018;18(1):99.

Franke H, Franke JD, et al. Osteopathic manipulative treatment for low back and pelvic girdle pain during and after pregnancy. J Bodyw Mov Ther. 2017;21(4):752-762.

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More in AFP

Alpha-Fetoprotein Test (AFP)

The Alpha-Fetoprotein Test (AFT) test is a screening test that examines the level of alpha-fetoprotein in the mother’s blood during pregnancy. This is not a diagnostic test. It is often part of the triple screen test that assesses whether further diagnostic testing may be needed.

What is a screening test and how is it done?

Screening tests, like the Alpha-Fetoprotein Test do not look only at results from the blood test. They compare a number of different factors (including age, ethnicity, results from blood tests , etc…) and then estimate what a person’s chances are of having an abnormality. These tests DO NOT diagnose a problem; they only signal that further testing should be done.

To perform the AFP test, blood is drawn from veins in the mother’s arm and sent off to a laboratory for analysis. Results are usually returned between one and two weeks.

When is the Alpha-Fetoprotein Test Test performed?

The AFP test may be performed between the 14th and 22nd weeks of pregnancy , however, it seems to be most accurate during the 16th to 18th week . Your levels of AFP vary during pregnancy so accurate pregnancy dating is imperative for more reliable screening results.

All pregnant women should be offered the AFP screening, but it is especially recommended for:

Women who have a family history of birth defects
Women who are 35 years or older
Women who used possible harmful medications or drugs during pregnancy
Women who have diabetes

What does the AFP test look for?

Alpha-fetoprotein (AFP) is found in both fetal serum and also amniotic fluid. This protein is produced early in gestation by the fetal yolk sac and then later in the liver and gastrointestinal tract. The true function of AFP is unknown. We do know that this protein’s level increases and decreases during certain weeks of pregnancy which is why accurate pregnancy dating is crucial.

The AFP test is measuring high and low levels of alpha-fetoprotein. The results are combined with the mother’s age and ethnicity in order to assess the probabilities of potential genetic disorders.

High levels of AFP may suggest the developing baby has a neural tube defect such as spina bifida or anencephaly. High levels of AFP may also suggest defects with the esophagus or failure of your baby’s abdomen to close. However, the most common reason for elevated AFP levels is inaccurate dating of the pregnancy.

Low levels of AFP and abnormal levels of hCG and estriol may indicate the developing baby has Trisomy 21( Down syndrome) , Trisomy 18 (Edwards Syndrome) or another type of chromosome abnormality.

Abnormal levels may also be a result of the following:

A multiples pregnancy
Pregnancies that are more or less advanced than thought

What do Alpha-Fetoprotein Test results mean?

It is important to remember that the AFP is a screening test and not a diagnostic test. This test only notes that a mother is at risk of carrying a baby with a potential disorder.

There are approximately 25 to 50 abnormal test AFP results for every 1,000 pregnancies tested. Of these abnormal results, only 1 in 16 to 1 in 33 will actually have a baby that has been affected by a neural tube defect or other condition.

75% to 90% of babies with neural tube #defects are discovered through AFP screening.

Abnormal test results warrant additional testing for making a diagnosis.

A more conservative approach involves performing a second MSAFP or complete triple screen test followed by a high definition ultrasound.

If the testing still maintains abnormal results, a more invasive procedure such as amniocentesis may be performed. Invasive procedures should be discussed thoroughly with your healthcare provider. It is also important to talk through further testing with your partner. Additional counseling and discussions with a counselor, social worker or minister may prove helpful.

What are the risks and side effects of AFP to the mother or baby?

Except for the discomfort of drawing blood, there are no risks or side effects associated with the AFP.

What about further testing?

The Alpha-fetoprotein test is not an invasive procedure and poses no known risks to the mother or baby. The AFP results may warrant additional testing.

The reasons to pursue further testing or not may vary from person to person and couple to couple. Performing further testing allows you to confirm a diagnosis and then provides you with certain opportunities:

Pursue potential medical interventions that may exist
Begin planning for a child with special needs
Start addressing anticipated lifestyle changes
Identify support groups and resources
Make a decision about carrying the child to term

Some individuals or couples may elect not to pursue further testing for various reasons:

They are comfortable with the results no matter what the outcome is
Because of personal, moral, or religious reasons, making a decision about carrying the child to term is not an option
Some parents choose not to allow any testing that poses any risk of harming the developing baby

It is important to discuss the risks and benefits of further testing thoroughly with your healthcare provider. Your healthcare provider will help you evaluate if the benefits from the results could outweigh any risks from the procedure.

Want to Know More?

Your First Prenatal Visit
Bonding With Your Baby: Making the Most of the First Six Weeks
7 Common Discomforts of Pregnancy
Nightfood Nighttime Ice Cream: Formulated to be pregnancy friendly

Compiled using information from the following sources:

1. William’s Obstetrics Twenty-Second Ed. Cunningham, F. Gary, et al, Ch. 13.

2. Mayo Clinic Complete Book of Pregnancy & Baby’s First Year Johnson, Robert V., et al, Ch. 6.

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Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence

Published: 27 August 2004
Volume 13 , pages 575–589, ( 2004 )

Cite this article

W. H. Wu 1 , 2 , 5 ,
O. G. Meijer 2 ,
K. Uegaki 1 , 2 ,
J. M. A. Mens 3 ,
J. H. van Dieën 2 ,
P. I. J. M. Wuisman 1 &
H. C. Östgaard 4

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392 Citations

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Pregnancy-related lumbopelvic pain has puzzled medicine for a long time. The present systematic review focuses on terminology, clinical presentation, and prevalence. Numerous terms are used, as if they indicated one and the same entity. We propose “pregnancy-related pelvic girdle pain (PPP)”, and “pregnancy-related low back pain (PLBP)”, present evidence that the two add up to “lumbopelvic pain”, and show that they are distinct entities (although underlying mechanisms may be similar). Average pain intensity during pregnancy is 50 mm on a visual analogue scale; postpartum, pain is less. During pregnancy, serious pain occurs in about 25%, and severe disability in about 8% of patients. After pregnancy, problems are serious in about 7%. The mechanisms behind disabilities remain unclear, and constitute an important research priority. Changes in muscle activity, unusual perceptions of the leg when moving it, and altered motor coordination were observed but remain poorly understood. Published prevalence for PPP and/or PLBP varies widely. Quantitative analysis was used to explain the differences. Overall, about 45% of all pregnant women and 25% of all women postpartum suffer from PPP and/or PLBP. These values decrease by about 20% if one excludes mild complaints. Strenuous work, previous low back pain, and previous PPP and/or PLBP are risk factors, and the inclusion/exclusion of high-risk subgroups influences prevalence. Of all patients, about one-half have PPP, one-third PLBP, and one-sixth both conditions combined. Overall, the literature reveals that PPP deserves serious attention from the clinical and research communities, at all times and in all countries.

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Predictors and consequences of long-term pregnancy-related pelvic girdle pain: a longitudinal follow-up study

Helen Elden, Annelie Gutke, … Hans-Christian Ostgaard

Treatment, Bracing, and Modalities in Pelvic Girdle Pain

Abramson D, Roberts SM, Wilson PD (1934) Relaxation of the pelvic joints in pregnancy. Surg Gynecol Obstet 58:595–613

Google Scholar

Albert H, Godskesen M, Westergaard J (2000) Evaluation of clinical tests used in classification procedures in pregnancy-related pelvic joint pain. Eur Spine J 9:161–166

Article CAS PubMed Google Scholar

Albert H, Godskesen M, Westergaard J (2001) Prognosis in four syndromes of pregnancy-related pelvic pain. Acta Obstet Gynecol Scand 80:505–510

Altman DG (1993) Practical statistics for medical research. Chapman & Hall, London

Alvarez R, Stokes IA, Asprinio DE, Trevino S, Braun T (1988) Dimensional changes of the feet in pregnancy. J Bone Joint Surg Am 70:271–274

CAS PubMed Google Scholar

Berezin D (1954) Pelvic insufficiency during pregnancy and after parturition. Acta Obstet Gynecol Scand 33 [Suppl 3]:1–101

Berg G, Hammar M, Möller-Nielsen J, Lindén U, Thorblad J (1988) Low back pain during pregnancy. Obstet Gynecol 71:71–75

Bird AR, Menz HB, Hyde CC (1999) The effect of pregnancy on footprint parameters: A prospective investigation. J Am Podiatr Med Assoc 89:405–409

Björklund K, Bergström S (2000) Is pelvic pain in pregnancy a welfare complaint? Acta Obstet Gynecol Scand 79:24–30

Article PubMed Google Scholar

Björklund K, Naessén T, Nordström ML, Bergström S (1999) Pregnancy-related back and pelvic pain and changes in bone density. Acta Obstet Gynecol Scand 78:681–685

Björklund K, Nordström ML, Odlind V (2000) Combined oral contraceptives do not increase the risk of back and pelvic pain during pregnancy or after delivery. Acta Obstet Gynecol Scand 79:979–983

Bombardier C, Kerr MS, Shannon HS, Frank JW (1994) A guide to interpreting epidemiologic studies on the etiology of back pain. Spine 19:2,047S–2,056S

Breen TW, Ransil BJ, Groves PA, Oriol NE (1994) Factors associated with back pain after childbirth. Anesthesiology 81:29–34

Brynhildsen J, Ekblad S, Hammar M (1995) Oral contraceptives and low back pain: Attitudes among physicians, midwives and physiotherapists. Acta Obstet Gynecol Scand 74:714–717

Brynhildsen J, Hansson Å, Persson A, Hammar M (1998) Follow-up of patients with low back pain during pregnancy. Obstet Gynecol 91:182–186

Bullock JE, Jull GA, Bullock MI (1987) The relationship of low back pain to postural changes during pregnancy. Aust J Physiother 33:10–17

Butler R, Fuller J (1998) Back pain following epidural anaesthesia in labour. Can J Anaesth 45:724–728

Carson RG, Swinnen SP (2002) Coordination and movement pathology: Models of structure and function. Acta Psychol (Amst) 110:357–364

Cherry N (1987) Physical demands of work and health complaints among women working late in pregnancy. Ergonomics 30:689–701

Commissaris DA, Nilsson-Wikmar LB, Van Dieën JH, Hirschfeld H (2002) Joint coordination during whole-body lifting in women with low back pain after pregnancy. Arch Phys Med Rehabil 83:1279–1289

Cooper H, Hedges LV (1994) The handbook of research synthesis. Russell Sage, New York

Crawford JS (1972) Lumbar epidural block in labour: A clinical analysis. Br J Anaesth 44:66–74

Damen L, Buyruk HM, Guler-Uysal F, Lotgering FK, Snijders CJ, Stam HJ (2001) Pelvic pain during pregnancy is associated with asymmetric laxity of the sacroiliac joints. Acta Obstet Gynecol Scand 80:1019–1024

Deyo RA (2000) Personal communication

Dietrichs E, Kogstad O (1991) “Pelvic girdle relaxation”: Suggested new nomenclature. Scand J Rheumatol 20 [Suppl 88 ]:3

Driessen F (1987) Postpartum pelvic arthropathy with unusual features. Br J Obstet Gynaecol 94:870–872

Dumas GA, Reid JG, Wolfe LA, Griffin MP, McGrath MJ (1995) Exercise, posture, and back pain during pregnancy. Clin Biomech (Bristol, Avon) 10:104–109

Endresen EH (1995) Pelvic pain and low back pain in pregnant women: An epidemiological study. Scand J Rheumatol 24:135–141

Erici I, Sjövall A (1963) Lumbago-sciatica and pregnancy. Acta Obstet Gynecol Scand 42 [Suppl 6]:42

Farbrot E (1952) The relationship of the effect and pain of pregnancy to the anatomy of the pelvis. Acta Radiol 38:403–407

Fast A, Shapiro D, Ducommun EJ, Friedmann LW, Bouklas T, Floman Y (1987) Low-back pain in pregnancy. Spine 12:368–371

Fast A, Weiss L, Parikh S, Hertz G (1989) Night backache in pregnancy: Hypothetical pathophysiological mechanisms. Am J Phys Med Rehabil 68:227–229

Fast A, Weiss L, Ducommun EJ, Medina E, Butler JG (1990) Low-back pain in pregnancy: Abdominal muscles, sit-up performance, and back pain. Spine 15:28–30

Foti T, Davids JR, Bagley A (2000) A biomechanical analysis of gait during pregnancy. J Bone Joint Surg Am 82:625–632

Fung BK, Kwong CM, Ho ES (1993) Low back pain of women during pregnancy in the mountainous district of central Taiwan. Chin Med J (Taipei) 51:103–106

Genell S (1949) Studies on insufficientia pelvis (gravidarum et puerperarum). Acta Obstet Gynecol Scand 28:1–37

Golomer E, Ducher D, Arfi GS, Sud R (1991) [Simple locomotion during load carrying in pregnant women]. J Gynecol Obstet Biol Reprod (Paris) 20:406–412

Grove LH (1973) Backache, headache and bladder dysfunction after delivery. Br J Anaesth 45:1,147–1,149

Hainline B (1994) Low-back pain in pregnancy. Adv Neurol 64:65–76

Hansen A, Jensen DV, Wormslev M, Minck H, Johansen S, Larsen EC, Wilken-Jensen C, Davidsen M, Hansen TM (1999) Symptom-giving pelvic girdle relaxation in pregnancy, II: Symptoms and clinical signs. Acta Obstet Gynecol Scand 78:111–115

Heckman JD, Sassard R (1994) Musculoskeletal considerations in pregnancy. J Bone Joint Surg Am 76:1,720–1,730

Howell CJ, Kidd C, Roberts W, Upton P, Lucking L, Jones PW, Johanson RB (2001) A randomised controlled trial of epidural compared with non-epidural analgesia in labour. BJOG 108:27–33

Howell CJ, Dean T, Lucking L, Dziedzic K, Jones PW, Johanson RB (2002) Randomised study of long-term outcome after epidural versus non-epidural analgesia during labour. BMJ 325:357

Kristiansson P, Svärdsudd K (1996) Discriminatory power of tests applied in back pain during pregnancy. Spine 21:2,337–2,343; [discussion 2,343]

Article Google Scholar

Kristiansson P, Svärdsudd K, Von Schoultz B (1996) Back pain during pregnancy: A prospective study. Spine 21:702–709

LaBan MM, Rapp NS (1996) Low back pain of pregnancy: Etiology, diagnosis, and treatment. Phys Med Rehabil Clin N Am 7:473–486

Lamoth CJ, Meijer OG, Wuisman PI, Van Dieën JH, Levin MF, Beek PJ (2002) Pelvis-thorax coordination in the transverse plane during walking in persons with nonspecific low back pain. Spine 27:E92–E99

Larsen EC, Wilken-Jensen C, Hansen A, Jensen DV, Johansen S, Minck H, Wormslev M, Davidsen M, Hansen TM (1999) Symptom-giving pelvic girdle relaxation in pregnancy, I: Prevalence and risk factors. Acta Obstet Gynecol Scand 78:105–110

Lindsel H, Irgens S (1984) [Pelvic instability: It is all about relief and avoiding pain]. Sygeplejersken (Danish) 84:4–8

Lynch FW (1920) The pelvic articulations during pregnancy, labor, and the puerperium: An X-ray study. Surg Gynecol Obstet 30:575–580

MacArthur A, MacArthur C, Weeks S (1995) Epidural anaesthesia and low back pain after delivery: A prospective cohort study. BMJ 311:1,336–1,339

PubMed Google Scholar

MacArthur AJ, MacArthur C, Weeks SK (1997) Is epidural anesthesia in labor associated with chronic low back pain? A prospective cohort study. Anesth Analg 85:1,066–1,070

MacArthur C, Lewis M, Knox EG, Crawford JS (1990) Epidural anaesthesia and long-term backache after childbirth. BMJ 301:9–12

MacArthur C, Knox G, Lewis M (1993) Epidural analgesia during childbirth: Association with backache is real. BMJ 307:64

CAS Google Scholar

MacEvilly M, Buggy D (1996) Back pain and pregnancy: A review. Pain 64:405–414

MacLennan AH, MacLennan SC, The Norwegian Association for Women with Pelvic Girdle Relaxation (Landforeningen for Kvinner Med Bekkenløsningsplager) (1997) Symptom-giving pelvic girdle relaxation of pregnancy, postnatal pelvic joint syndrome and developmental dysplasia of the hip. Acta Obstet Gynecol Scand 76:760–764

Mannion AF, Taimela S, Munterer M, Dvorak J (2001) Active therapy for chronic low back pain, Part I: Effects of back muscle activation, fatigability, and strength. Spine 26:897–908

Mannion AF, Taimela S, Munterer M, Dvorak J (2001) Poor back muscle endurance: A psychological or physiological limitation? Abstracts of the 28th Annual Meeting of the International Society for the Study of the Lumbar Spine, Edinburgh, Scotland, June 19–23, 2001, pp 147

Mantle MJ, Greenwood RM, Currey HL (1977) Backache in pregnancy. Rheumatol Rehabil 16:95–101

Mantle MJ, Holmes J, Currey HL (1981) Backache in pregnancy, II: Prophylactic influence of back care classes. Rheumatol Rehabil 20:227–232

Melzack R, Bélanger E (1989) Labour pain: Correlations with menstrual pain and acute low-back pain before and during pregnancy. Pain 36:225–229

Melzack R, Schaffelberg D (1987) Low-back pain during labor. Am J Obstet Gynecol 156:901–905

Mens JM, Vleeming A, Stoeckart R, Stam HJ, Snijders CJ (1996) Understanding peripartum pelvic pain: Implications of a patient survey. Spine 21:1,363–1,369; [discussion 1,369–1,370]

Mens JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ (2001) Reliability and validity of the active straight leg raise test in posterior pelvic pain since pregnancy. Spine 26:1167–1171

Mens JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ (2002) Validity of the active straight leg raise test for measuring disease severity in patients with posterior pelvic pain after pregnancy. Spine 27:196–200

Mens JM, Vleeming A, Snijders CJ, Ronchetti I, Ginai AZ, Stam HJ (2002) Responsiveness of outcome measurements in rehabilitation of patients with posterior pelvic pain since pregnancy. Spine 27:1,110–1,115

Mens JM, Vleeming A, Snijders CJ, Ronchetti I, Stam HJ (2002) Reliability and validity of hip adduction strength to measure disease severity in posterior pelvic pain since pregnancy. Spine 27:1,674–1,679

Mens JMA (2000) Pregnancy-related low back pain. Erasmus University, Rotterdam, The Netherlands

Moir DD, Davidson S (1972) Postpartum complications of forceps delivery performed under epidural and pudendal nerve block. Br J Anaesth 44:1197–1199

Moon WN, Kim MY, Oh HJ, Suh SW, Kim IC, Choi YH, Ahn JY (2000) [Incidence and risk factors of pelvic pain in pregnancy]. J Korea Spine Surg (Korean) 7:259–263

Mooney V, Pozos R, Vleeming A, Gulick J, Swenski D (2001) Exercise treatment for sacroiliac pain. Orthopedics 24:29–32

Mulholland RC (1999) Reviewer’s comment. Eur Spine J 8:474

Nagy LE, King JC (1983) Energy expenditure of pregnant women at rest or walking self-paced. Am J Clin Nutr 38:369–376

Nilsson-Wikmar L, Harms-Ringdahl K, Pilo C, Pahlback M (1999) Back pain in women post-partum is not a unitary concept. Physiother Res Int 4:201–213

Norén L, Östgaard S, Johansson G, Östgaard HC (2002) Lumbar back and posterior pelvic pain during pregnancy: A 3-year follow-up. Eur Spine J 11:267–271

Nwuga VCB (1982) Pregnancy and back pain among upper-class Nigerian women. Aust J Physiother 28:8–11

Nyska M, Sofer D, Porat A, Howard CB, Levi A, Meizner I (1997) Plantar foot pressures in pregnant women. Isr J Med Sci 33:139–146

Orvieto R, Achiron A, Ben-Rafael Z, Gelernter I, Achiron R (1994) Low-back pain of pregnancy. Acta Obstet Gynecol Scand 73:209–214

Östgaard HC (1996) Assessment and treatment of low back pain in working pregnant women. Semin Perinatol 20:61–69

Östgaard HC, Andersson GB (1991) Previous back pain and risk of developing back pain in a future pregnancy. Spine 16:432–436

Östgaard HC, Andersson GB (1992) Postpartum low-back pain. Spine 17:53–55

Östgaard HC, Andersson GB, Karlsson K (1991) Prevalence of back pain in pregnancy. Spine 16:549–552

Östgaard HC, Andersson GB, Wennergren M (1991) The impact of low back and pelvic pain in pregnancy on the pregnancy outcome. Acta Obstet Gynecol Scand 70:21–24

Östgaard HC, Zetherström G, Roos-Hansson E (1994) The Posterior Pelvic Pain Provocation test in pregnant women. Eur Spine J 3:258–260

Östgaard HC, Zetherström G, Roos-Hansson E, Svanberg B (1994) Reduction of back and posterior pelvic pain in pregnancy. Spine 19:894–900

Östgaard HC, Roos-Hansson E, Zetherström G (1996) Regression of back and posterior pelvic pain after pregnancy. Spine 21:2,777–2,780

O’Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A (2002) Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine 27:E1–E8

Padua L, Padua R, Bondi R, Ceccarelli E, Caliandro P, D’Amico P, Mazza O, Tonali P (2002) Patient-oriented assessment of back pain in pregnancy. Eur Spine J 11:272–275

Paul JA, Van Dijk FJ, Frings-Dresen MH (1994) Work load and musculoskeletal complaints during pregnancy. Scand J Work Environ Health 20:153–159

Percy-Lancaster R (1969) Pelvic arthropathy. S Afr Med J 43:551–557

Perkins J, Hammer RL, Loubert PV (1998) Identification and management of pregnancy-related low back pain. J Nurse Midwifery 43:331–340

Renckens CN (2000) Between hysteria and quackery: Some reflections on the Dutch epidemic of obstetric ‘pelvic instability’. J Psychosom Obstet Gynaecol 21:235–239

Reynolds F, Russell R (1998) Epidural analgesia does not cause long-term backache. BMJ 316:69–70

Rungee JL (1993) Low back pain during pregnancy. Orthopedics 16:1,339–1,344

Russell R, Groves P, Taub N, O’Dowd J, Reynolds F (1993) Assessing long-term backache after childbirth. BMJ 306:1,299–1,303

Russell R, Dundas R, Reynolds F (1996) Long-term backache after childbirth: Prospective search for causative factors. BMJ 312:1,384–1,388

Sands RX (1958) Backache of pregnancy: A method of treatment. Obstet Gynecol 12:670–676

Saugstad LF (1991) Is persistent pelvic pain and pelvic joint instability associated with early menarche and with oral contraceptives? Eur J Obstet Gynecol Reprod Biol 41:203–206

Saugstad LF (1991) Persistent pelvic pain and pelvic joint instability. Eur J Obstet Gynecol Reprod Biol 41:197–201

Sihvonen T, Huttunen M, Makkonen M, Airaksinen O (1998) Functional changes in back muscle activity correlate with pain intensity and prediction of low back pain during pregnancy. Arch Phys Med Rehabil 79:1,210–1,212

Slate WG (1960) Pelvic girdle relaxation. Obstet Gynecol 16:625–670

Snelling FG (1870) Relaxation of the pelvic symphyses during pregnancy and parturition. Am J Obstet Dis Women Child 2:1–37

Sturesson B, Udén G, Udén A (1997) Pain pattern in pregnancy and “catching” of the leg in pregnant women with posterior pelvic pain. Spine 22:1,880–1,883; [discussion 1,884]

Suputtitada A, Wacharapreechanont T, Chaisayan P (2002) Effect of the “sitting pelvic tilt exercise” during the third trimester in primigravidas on back pain. J Med Assoc Thai 85 [Suppl 1]:S170-S179

Svensson HO, Andersson GB, Hagstad A, Jansson PO (1990) The relationship of low-back pain to pregnancy and gynecologic factors. Spine 15:371–375

Taves C, Charteris J, Wall JC (1982) The kinematics of treadmill walking during pregnancy. Physiother Can 34:321–324

Thomas IL, Nicklin J, Pollock H, Faulkner K (1989) Evaluation of a maternity cushion (Ozzlo pillow) for backache and insomnia in late pregnancy. Aust N Z J Obstet Gynaecol 29:133–138

Thompson JF, Roberts CL, Currie M, Ellwood DA (2002) Prevalence and persistence of health problems after childbirth: Associations with parity and method of birth. Birth 29:83–94

Turgut F, Turgut M, Çetinsahin M (1998) A prospective study of persistent back pain after pregnancy. Eur J Obstet Gynecol Reprod Biol 80:45–48

Van Dongen PW, De Boer M, Lemmens WA, Theron GB (1999) Hypermobility and peripartum pelvic pain syndrome in pregnant South African women. Eur J Obstet Gynecol Reprod Biol 84:77–82

Vleeming A, De Vries HJ, Mens JM, Van Wingerden JP (2002) Possible role of the long dorsal sacroiliac ligament in women with peripartum pelvic pain. Acta Obstet Gynecol Scand 81:430–436

Wagenaar RC, Van Emmerik REA (1996) Dynamics of movement disorders. Hum Mov Sci 15:161–175

Wergeland E, Strand K (1998) Work pace control and pregnancy health in a population-based sample of employed women in Norway. Scand J Work Environ Health 24:206–212

Wickstrom J, Haslam ET, Hutchinson RT (1955) Backache during pregnancy: Its etiology and management. J La State Med Soc 107:490–494

Wormslev M, Juul AM, Marques B, Minck H, Bentzen L, Hansen TM (1994) Clinical examination of pelvic insufficiency during pregnancy: An evaluation of the interobserver variation, the relation between clinical signs and pain and the relation between clinical signs and physical disability. Scand J Rheumatol 23:96–102

Wu W, Meijer OG, Jutte PC, Uegaki K, Lamoth CJ, De Wolf SG, Van Dieën JH, Wuisman PI, Kwakkel G, De Vries JI, Beek PJ (2002) Gait in patients with pregnancy-related pain in the pelvis: An emphasis on the coordination of transverse pelvic and thoracic rotations. Clin Biomech (Bristol, Avon) 17:678–686

Young G, Jewell D (2002) Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev CD:001139

Young J (1939) Pelvic osteo-arthropathy of pregnancy. Proc R Soc Med 32:1591–1597

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Acknowledgements

Financial support was obtained from Stryker/Howmedica, the Dutch Society of Exercise Therapists Mensendieck (NVOM), and the Mensendieck Development Foundation (SOM). An earlier version of this paper was published in the Nederlands Tijdschrift voor Oefentherapie-Mensendieck [Dutch Journal for Exercise Therapy Mensendieck], 2001 (1), pp 25–34, and the authors thank the editors for their permission to use the material, Lisette Hamersma (Amsterdam) and Rolf van den Langenberg (Amsterdam) for their contribution to this earlier version, as well as Claudine J.C. Lamoth (Amsterdam), G. Sander de Wolf (Amsterdam), Richard A. Deyo (Seattle), and Liesbeth van der Weerd (Zeist) for their comments on an earlier draft of the present paper

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Department of Orthopaedics, Vrije Universiteit Medical Centre (VUMC), Amsterdam, The Netherlands

W. H. Wu, K. Uegaki & P. I. J. M. Wuisman

Faculty of Human Movement Sciences, Vrije Universiteit, Room D 656, Van der Boechorststraat 9, 1081 BT , Amsterdam, The Netherlands

W. H. Wu, O. G. Meijer, K. Uegaki & J. H. van Dieën

Department of Rehabilitation Medicine, Erasmus Medical Centre, P.O. Box 1738, 3000 DR, Rotterdam, The Netherlands

J. M. A. Mens

Department of Orthopaedics, Sahlgren University Hospital, 43180, Mölndal, Sweden

H. C. Östgaard

Department of Orthopaedics, Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian Province, People’s Republic of China

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Correspondence to O. G. Meijer .

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Wu, W.H., Meijer, O.G., Uegaki, K. et al. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J 13 , 575–589 (2004). https://doi.org/10.1007/s00586-003-0615-y

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Received : 28 April 2003

Accepted : 25 July 2003

Published : 27 August 2004

Issue Date : November 2004

DOI : https://doi.org/10.1007/s00586-003-0615-y

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Multisource Generic FPPs

Classification of variations and assessment timelines.

The WHO variation guidelines classify four types of variation:

annual notification (AN)
immediate notification (IN)
minor variation (Vmin)
major variation (Vmaj).

A variation is classified according to its potential adverse effect on the quality, safety and/or efficacy of the product concerned. Each type of variation has its own approval mechanism and timeline. Applicants must satisfy themselves that they meet all of the prescribed conditions for the change and submit all required documentation with the variation application.

Variations approval mechanism and timelines (PDF)

A variation is classified as major (Vmaj) if it could have major effects on the overall quality, safety and efficacy of the finished pharmaceutical product (FPP). If a change is not described in the WHO guidelines, it is considered to be a major variation by default.

The general principle for determining the category of any given change is to start by determining whether the conditions and documentation requirements for the least significant category (AN → IN → Vmin) can be met. If the change does not comply with those conditions, the applicant should proceed to check compliance with the next category. Should the change not meet the conditions of either the AN or IN or Vmin category it will be considered to be a major variation (Vmaj) by default.

The list of variations described in the variation guidelines is not exhaustive. If a change is not described, please refer to FAQ: variation document (under point 8) for detailed instructions on how to handle such an unclassified change.

The variation guidelines explain the potential impacts on product quality of the different changes and are therefore useful as a risk management tool for promoting or enhancing best practices.

Grouping of changes (variations) for submission

In general, each change requires submission of a separate variation. Grouping of variations is acceptable only under the following circumstances.

the variations are consequential to each other, e.g. introduction of a new impurity specification that requires a new test method
the same change affects multiple FPPs from the same applicant e.g. addition of a new active pharmaceutial ingredient (API) manufacturing site for multiple FPPs
each of the changes is of the AN type.

For the purpose of classification, an application involving two or more types of variation will be considered as of the highest risk type. For example, a variation submission that includes both a minor variation (Vmin) and a major variation (Vmaj) will be classified as a major variation (Vmaj).

Care should be exercised whenever several changes to the same FPP are envisaged. Although individual changes may be classified as of a particular reporting type, classification in a higher risk category may be warranted as a result of the composite effect of these changes. In such cases, applicants are advised to contact WHO for guidance, before submission of the variation application.

API-related changes

An API manufacturer that makes a change to the preparation and/or control of any of its APIs should inform FPP manufacturers that incorporate any of those APIs in their own products. In the case of a prequalified FPP, it is the responsibility of the FPP applicant to submit a variation application to PQTm. However, the notification requirements for API-related changes differ depending on which of the four options for submitting information relating to the API was selected when the application for FPP prequalification was made:

option 1: by referring to an API that had already been prequalified
option 2: by submitting a copy of a European Pharmacopoeia Certificate of Suitability (CEP) issued by European Directorate for the Quality of Medicines and HealthCare (EDQM) for an API
option 3: through use of the APIMF procedure
option 4: through provision of a full description within the FPP dossier.

A scenario is given below for each option, for illustrative purposes.

Scenario 1: A prequalified FPP supported by a prequalified API (CPQ)

The API supplier is responsible for seeking approval for an API-related change from WHO. The API supplier is also responsible for informing any FPP manufacturer using its API of any changes it has made to its preparation and control. Manufacturers of prequalified APIs should refer to the amendment guidance.

The FPP applicant does not need to make a variation submission to WHO unless the associated Confirmation of API prequalification document (CPQ) issued by WHO has been revised. (Please refer to variation number 6 of the guidelines.) However, any changes to API details not covered by the CPQ — such as particle size or polymorphic form — should be submitted as a variation by the FPP manufacturer, in accordance with the variation categories described in the variation guidelines.

Scenario 2: A prequalified FPP supported by a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)

The API supplier is responsible for seeking approval from the EDQM for any change to the API . The API supplier is also responsible for informing any FPP manufacturer using its API of any changes it has made to its preparation and control.

The FPP applicant does not need to make a variation submission to WHO unless the associated CEP has been revised. (Please refer to variation number 5 the guidelines.) However, any changes to API details not covered by the CEP — such as particle size, polymorphic form or retest period, if applicable — should be submitted as a variation by the FPP manufacturer, in accordance with the variation categories described in the variation guidelines .

Scenario 3: Prequalified FPP supported by an associated APIMF

If an FPP has been prequalified upon the basis of an APIMF that has been accepted by WHO, the APIMF holder should notify WHO of any changes in API details, in the form of an amendment to the APIMF. A variation should not be submitted by the FPP manufacturer until the amendment has been accepted.

Upon acceptance of the APIMF amendment, the FPP manufacturer should submit the type of variation required as defined in the variation guidelines. In some instances, though — for example, if the APIMF amendment related to the restricted part (confidential information) part of the APIMF — submission of a variation may be unnecessary.

API manufacturers should refer to the amendment guidance.

Scenario 4: A prequalified FPP for which API information was provided in full, within the FPP dossier

If the prequalified FPP does not rely upon a prequalified API or CEP or APIMF, any change to the preparation and control of the API is the responsibility of the FPP manufacturer and must be submitted to WHO as a variation, in accordance with the categories described in the variation guidelines.

New applications/extension applications

Certain changes alter the terms of the accepted FPP dossier. In these cases a new FPP dossier must be submitted. Examples of such changes are listed in Appendix 1 of the WHO Guidelines on variations to a prequalified product .

Labelling information

In the case of any change to product information (summary of product characteristics, patient information leaflet or labelling) not covered by the variation categories described in the WHO variation guidelines (see below), the revised labelling should be submitted toWHO. An email acknowledging receipt will be sent to the applicant within 7 calendar days following receipt. Acceptance by WHO required before any changes can be implemented. The timeline for assessment will vary depending on the nature of the changes.

This information is intended for FPP manufacturers who submitted complete active pharmaceutical ingredient (API) information with their finished pharmaceutical product (FPP) dossier at the time of prequalification.

FPP manufacturers who submitted API information through the APIMF procedure or that use a prequalified API typically will not be required to take any action. The API manufacturer themselves are responsible for submitting an amendment to their APIMF to introduce a new source of non-plant-derived-artemisinin (refer to Clarification: Introduction of a supplier of non-plant-derived-artemisinin below and in the Amendments to APIMFs section).

Manufacturers of non-plant-derived-artemisinin should refer to the prequalification guidance Clarification on the process for introducing a supplier of non-plant-derived artemisinin .

FPP manufacturers who wish to introduce a source of non-plant-derived-artemisinin should submit an amendment as per the standard variation procedure.

The following documentation should be submitted with the application.

A copy of the letter of access provided by the supplier of the non-plant-derived artemisinin.
The name and address of the manufacturing site producing the non-plant-derived-artemisinin.
A brief description of the preparation of the non-plant derived artemisinin, but including, at a minimum, all reaction intermediates, reagents and solvents.
A single harmonized set of specifications, issued by the active pharmaceutical ingredient (API) manufacturer for the control of artemisinin (irrespective of source) and a justification for these specifications.
A certificate of analysis for a batch of non-plant-derived-artemisinin issued by the artemisinin supplier and issued by the API manufacturer upon re-testing.
Data verifying that the use of non-plant-derived-artemisinin affords the target API, or a preceding intermediate of the same quality and does not lead to carry-over of unacceptable impurity content.
A revised FPP dossier to include details of the new supplier. Note that despite being considered, in principle, an API intermediate, it is suggested that information on this substance be included in section 3.2.S.2.3 (and applicable annexes), as would be expected when including information on any other additional API starting material supplier. Additionally, it is suggested that the information be included in section 3.2.S.2.3 rather than in section 3.2.S.2.4 given the advantages in maintaining information on all sources of artemisinin in a single place within the dossier.

Currently accepted supplier of non-plant-derived-artemisinin

The following company has been accepted as a supplier of non-plant-derived-artemisinin:

Company: Sanofi-Aventis SpA

Manufacturing site: Huvepharma Italia S.r.l. Via R Lepetit 142 Garessio 12075 Italy

Date of acceptance by WHO: 7 May 2013

Guidelines on variations to a prequalified product (2013)

Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for WHO prequalification: quality part (2012)

Guidelines on submission of documentation for a multisource (generic) finished product. Preparation of product dossiers in CTD format (2011)

Clarification on the process for introducing a supplier of non-plant derived artemisinin (1 November 2016)

EDQM Certificate of suitability

M Medicines

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Fetal presentation: Breech, posterior, transverse lie, and more
Fetal presentation, or how your baby is situated in your womb at birth, is determined by the body part that's positioned to come out first, and it can affect the way you deliver. ... Like the transverse lie, this position is more common earlier in pregnancy, and it's likely your provider will intervene if your baby is still in the oblique lie ...
Family Planning
FP Teen Presentation 2023. FP Teen Presentation 2023. National Clinical Training Center for Family Planning - NCTCFP ... NMDOH FPP 2021 Title X Orientation Non-Clinical Training. ... including adolescent pregnancy, family planning, and sterilization, as well as other population issues.
Utility of Doppler parameters at 36-42 weeks' gestation in the
Introduction. Doppler ultrasound is used to assess the flow in umbilical artery (UA) and fetal middle cerebral artery (MCA). The pulsatility index (PI) is used to calculate the cerebroplacental ratio (CPR), which is used for the assessment of fetal oxygenation (2-3).Abnormal Doppler findings in the third trimester are typically associated with adverse perinatal outcome (4-6).
Fetal Presentation, Position, and Lie (Including Breech Presentation)
Normally, the presentation is vertex (head first), and the position is occiput anterior (facing toward the pregnant person's spine) and with the face and body angled to one side and the neck flexed. Variations in fetal presentations include face, brow, breech, and shoulder.
Family planning and pregnancy issues for women with systemic ...
Objectives To identify family planning and pregnancy (FPP) issues for female patients of childbearing age living with a chronic inflammatory disease and to assess whether current clinical practice routinely provides adequate support to alleviate these concerns. Setting Multinational survey and an analysis of online patient activity. Participants Premenopausal women (aged 20-45 years; N=969 ...
West Virginia Family Planning Program
WV's Family Planning Program provides outreach and education through the Adolescent Pregnancy Prevention Initiative (APPI). Outreach and education are accomplished by: •. Working with public schools to provide student education through classroom. presentations, parent education and reproductive health professional. development for educators.
Family planning and pregnancy issues for women with systemic ...
Objectives: To identify family planning and pregnancy (FPP) issues for female patients of childbearing age living with a chronic inflammatory disease and to assess whether current clinical practice routinely provides adequate support to alleviate these concerns. Setting: Multinational survey and an analysis of online patient activity.
West Virginia Adolescent Pregnancy Prevention Initiative (APPI ...
The Adolescent Pregnancy Prevention Initiative (APPI) is responsible for community outreach and education for West Virginia's Title X Family Planning Program. APPI provides statewide development, oversight, and coordination of adolescent pregnancy prevention activities. The mission of this Initiative is to support teens as they explore and ...
A Radiologist's Guide to the Performance and Interpretation of
Doppler US provides a unique window to the fetoplacental circulation, allowing assessment of fetal well-being. Doppler US of the umbilical artery is an integral component of managing the fetus with growth restriction; and Doppler US of the middle cerebral artery, as a noninvasive means of detecting fetal anemia, has revolutionized the management of pregnancies complicated by alloimmunization ...
Fetal and umbilical Doppler ultrasound in normal pregnancy
Doppler ultrasound uses sound waves to detect the movement of blood in vessels. It is used in pregnancy to study blood circulation in the baby, uterus and placenta. Using it in high-risk pregnancies, where there is concern about baby's condition, shows benefits.
The Pregnant Patient: Managing Common Acute Medical Problems
Signs and symptoms of dermatoses in pregnancy include pruritus, papules, and plaques. Notably, pruritic urticarial papules and plaques of pregnancy spare the umbilicus ( eFigure C). Treatment of ...
PDF Common Terms and Abbreviations Used in Pregnancy Care
G6P1132 = the woman is currently pregnant with her sixth pregnancy. She had one full-term delivery, one premature delivery, three abortions or miscarriages, and has two living children (the full term and preterm babies). G3P2002 - the woman is pregnant with her third pregnancy and has two living kids who were born full term.
Awareness and Expectations Surrounding Family Planning and Pregnancy
Here, we report on the access to family planning and pregnancy (FPP) information and the concerns among patients in Denmark with CIDs. Methods: Patients aged 18-50 years with CIDs participated in an online survey. Patients were recruited through patient advocacy groups and were asked to report information on their diagnosis, concerns related to ...
Alpha-Fetoprotein Test
The AFP test is measuring high and low levels of alpha-fetoprotein. The results are combined with the mother's age and ethnicity in order to assess the probabilities of potential genetic disorders. High levels of AFP may suggest the developing baby has a neural tube defect such as spina bifida or anencephaly. High levels of AFP may also ...
West Virginia Adolescent Pregnancy Prevention Initiative (APPI ...
The Adolescent Pregnancy Prevention Initiative works to increase public awareness about problems resulting from early sexual activity and childbearing. APPI collaborates with existing community organizations to promote local activities. APPI provides abstinence-based education but includes information about contraception and access to family ...
Family planning with inflammatory bowel disease: the challenge of
Accordingly, concerns about family planning and pregnancy (FPP) are common. Poor knowledge regarding FPP might contribute to increased childlessness in patients with IBD. Methods: The Crohn's and Colitis Pregnancy Knowledge Score (CCPKnow, 17 multiple-choice questions) was translated into German and then used for a web-based survey ...
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FPP grantees must follow the algorithms for the management of the specific type of abnormal result and in consideration of special populations (for example, pregnant women and clients 20 years and younger or at high risk). 5720 Breast Cancer Screening. Revision 23-4; Effective Nov. 17, 2023
Alpha-Fetoprotein (AFP) Screening Test: Purpose, Procedure, Results
You do a maternal serum alpha-fetoprotein test when you're about 4 months pregnant. A technician uses a needle to take a small sample of blood from a vein in your hand or arm. You may feel a small ...
Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical
Pregnancy-related lumbopelvic pain has puzzled medicine for a long time. The present systematic review focuses on terminology, clinical presentation, and prevalence. Numerous terms are used, as if they indicated one and the same entity. We propose "pregnancy-related pelvic girdle pain (PPP)", and "pregnancy-related low back pain (PLBP)", present evidence that the two add up to ...
NM Department of Health Family Planning Program (FPP) Title X Annual
• By the end of the presentation, participants will be able to: To provide participants with pertinent updates in the Title X Family Planning Program (FPP) grant administration in 2024. Understand the changes in the FPP staff training requirements. Recognize the major changes in the FPP Protocol revisions.
Multisource Generic FPPs
In the case of a prequalified FPP, it is the responsibility of the FPP applicant to submit a variation application to PQTm. However, the notification requirements for API-related changes differ depending on which of the four options for submitting information relating to the API was selected when the application for FPP prequalification was made:
Free Pregnancy PowerPoint Templates
Free Pregnancy PowerPoint Templates are suitable template designs for health presentations. Under this section, you will find the templates on pregnancy health and pregnancy control medicines. The presentations on doctors can also use these designs to teach about pregnancy or other issues that pregnant women may encounter during the pregnancy weeks.

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