Enrolling Pregnant Women: Issues in Clinical Research

Blehar, Mary C.; Spong, Catherine Y.; Grady, Christine; Goldkind, Sara F.; Şahin, Leyla; Clayton, Janine Austin

doi:10.1016/j.whi.2012.10.003

Cited by 205 publications

(212 citation statements)

References 21 publications

Supporting

Mentioning

203

Contrasting

Unclassified

Order By: Relevance

“…Pregnant women have traditionally been excluded from biomedical research, which results in a lack of knowledge about the risks and potential benefits of medicinal products in this population [28]. However, a call to include pregnant women in clinical studies was made by the Institute of Medicine in 1994 [29] and recent publications advocate a change in the presumption of exclusion of pregnant women from clinical studies to one of inclusion [30]. This has resulted in more than 250 clinical trials in pregnancy being registered between 2009 and 2011 [31].…”

Section: Discussionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

show abstract

Section: Discussionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…High disease activity is associated with an increased risk of pregnancy complications and adverse outcomes, including preeclampsia, preterm delivery, low birth weight, small for gestational age, and fetal loss 5, 6, 7, 8, 9, 10, 11, 12, 13. Adequate disease control during pregnancy is therefore paramount for fetal and maternal health, as acknowledged by recent publications 6, 14, 15, 16, and the risks of untreated disease during pregnancy should be evaluated against the risks related to drug exposure of mother and fetus. However, some treatments are not used in pregnant patients, due to proven teratogenicity (for example, methotrexate) or because of concerns due to the absence of a well‐established safety profile in pregnancy 16.…”

mentioning

confidence: 99%

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Clowse

Scheuerle

Chambers

et al. 2018

Arthritis & Rheumatology

142

View full text Add to dashboard Cite

ObjectiveAnti–tumor necrosis factor (anti‐TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti‐TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc‐free anti‐TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy.MethodsProspective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.ResultsOf 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.ConclusionThis analysis represents the largest cohort of pregnant women exposed to an anti‐TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.

show abstract

“…While the focus of this review is on women, the long-term impact of in-utero HIV exposure on the extended health outcomes and epigenetics of HIV-exposed, uninfected children is also warranted. 2,56 Recent data from the PRO-MISE study are a reminder of the continued importance of careful monitoring of the effects of antiretrovirals on morbidity and mortality of antiretroviral exposed infants as well, particularly as new drugs and classes of drugs come to market. 57 Female sex workers As occupation generally defines the social perceptions of female sex workers, the fertility-related needs of women engaged in sex work often remain invisible.…”

Section: Resultsmentioning

confidence: 99%

“…1 Consequently, the Office of Research on Women's Health within the National Institutes of Health in the United States has concluded that there is a clear need for responsible research in pregnant women to address these gaps. 2 Moreover, some women are particularly underrepresented within fertility-related research, due to their occupation, health status, behaviours, or sexual and gender identity. 3 Specifically, women often forgotten in fertility-related investigations include female sex workers, women living with or affected by HIV, women who use drugs, and lesbian, gay, bisexual and transgender (LGBT) women ( Figure 1).…”

Section: Introductionmentioning

confidence: 99%

Fertility-related research needs among women at the margins

Schwartz¹,

Baral

2015

Reproductive Health Matters

View full text Add to dashboard Cite

Fertility-related research encompasses fertility intentions, preconception care, research amongst pregnant women, and post-partum outcomes of mothers and children. However, some women remain underrepresented within this domain of study. Women frequently missing within fertility-related research include those who are already the most vulnerable to health disparities, including female sex workers, lesbian, gay, bisexual, and transgender women, women living with HIV, and women who use drugs. Yet characterization of the needs of these women is important, given their unique fertility-related concerns, including risks and barriers to care emanating from social stigmas and discrimination. This synthesis provides an overview of fertility-related evidence, highlighting where there are clear research gaps among marginalized women and the potential implications of these data shortfalls. Overall, research among marginalized women to date has addressed pregnancy prevention and in some cases fertility intentions, but the majority of studies have focused on postconception pregnancy safety and the well-being of the child. However, among female sex workers specifically, data on pregnancy safety and the well-being of the child are largely unavailable. Within each marginalized group, preconception care and effectiveness of conception methods are consistently understudied. Ultimately, the absence of epidemiologic, clinical and programmatic evidence limits the availability and quality of reproductive health services for all women and prevents social action to address these gaps.

show abstract

Enrolling Pregnant Women: Issues in Clinical Research

Cited by 205 publications

References 21 publications

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Pregnancy Outcomes After Exposure to Certolizumab Pegol

Fertility-related research needs among women at the margins

Contact Info

Product

Resources

About