key: cord-0935618-t2x6vyem
authors: Dangel, Alissa; Yu, Vanessa; Liang, Caroline; Beninger, Paul
title: Mind the Gap: COVID-19 highlights the research void in pregnancy
date: 2022-01-13
journal: Am J Obstet Gynecol MFM
DOI: 10.1016/j.ajogmf.2022.100566
sha: 58f882bea61d78f72233e2b01099f99e37d09256
doc_id: 935618
cord_uid: t2x6vyem

nan

The COVID-19 pandemic has generated a massive media presence and with that has come the opportunity for the public to gain an in-depth view of the clinical research process -and the glaring lack of research involving pregnant people. It is well recognized that pregnancy presents unique challenges to scientific discovery, and consequently, the number of clinical trials involving pregnant people is significantly limited. 1 The surge of COVID-19 research provides a unique opportunity to evaluate the research landscape regarding pregnancy. Interventions in Response to . Of the remaining studies, twenty-one were removed due to criteria that were deemed incompatible for inclusion of pregnant people (e.g. limited to male gender, not related to COVID-19, geriatric age range) leaving 754 studies. Determination of the potential for pregnant people to participate in those trials was then evaluated by individual review of the study inclusion and exclusion criteria. Based on our evaluation, 83% (626/754) excluded pregnant participants.

Exclusion of pregnant participants from clinical trials that investigate therapies for a new disease process such as COVID-19 is not surprising. 3 

History has taught us, appropriately, to be cautious regarding research in this population. Babies born with phocomelia from in-utero exposure to thalidomide in the 1960's demonstrated the potential consequences of drug use during pregnancy. Since then, the FDA has incorporated special guidance related to consideration of inclusion of pregnant people in clinical trials for both pregnancy-specific conditions as well as general medical conditions. 4 While this guidance provides useful context, monitoring for clinical trial outcomes related to pregnancy and newborn health can take extended periods of time to complete. The professional and financial resources necessary to accomplish these objectives can also be quite significant; notably, there is currently no infrastructure in place to adequately address these issues.

A similar situation routinely occurred in pediatrics. Prior to legislative measures taken in the 1990s, regulators had been unsuccessful in making the case to industry that they should generate the necessary information to enable companies to label their products with information on the safe use of newly approved drugs in children. 5 As a result, most drugs used in children up into the mid-1990s were 

The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy

Enrolling pregnant women in research--lessons from the H1N1 influenza pandemic

Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines

Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry, The Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research In

Author Contributions: All authors contributed equally to the development and writing of this