Abstract

Background

There is an urgent need to prioritize and expedite the inclusion of pregnant and breastfeeding women in research. Characterizing trials that have successfully included these populations could inform the design and execution of future studies. In addition, up-to-date data on their inclusion in clinical research could assist in setting benchmarks, establishing targets, and monitoring progress towards more equitable inclusion.

Objective

The primary objective of this study was to characterize the eligibility and enrollment of pregnant and breastfeeding women in randomized controlled trials (RCTs) evaluating interventions for non-obstetric conditions experienced by, but not limited to, these populations.

Results

Of 1333 RCTs, pregnant and breastfeeding women were eligible for 13 (1.0%) and 6 (0.5%), respectively. Pregnancy and breastfeeding eligibility criteria were not addressed in 383/1333 (28.7%) and 710/1333 (53.3%) RCTs, respectively. In total, 102/937 (10.9%) and 33/617 (5.3%) RCTs that explicitly excluded pregnant and breastfeeding women documented the rationale. Most studies excluding pregnant women (542/937, 57.8%) required at least one method of contraception and/or pregnancy testing as part of trial participation for women with reproductive capacity. Amongst the 13 RCTs that allowed inclusion of pregnant women, three restricted eligibility to specific  trimesters. Two RCTs enrolled pregnant women after the first year of the study following interim review of safety results in non-pregnant participants. Four RCTs reported the number of pregnant women enrolled, which ranged from 0.7% to 3.4% of the study population. None of the studies reported on pregnancy or perinatal outcomes. Compared to RCTs that excluded pregnant women, those including them more commonly had an infectious disease focus (12/13, 92.3% vs. 270/937, 28.8%; p<0.0001), including HIV (5/13, 38.5% vs. 96/937, 10.2%; p=0.0079), enrolled in Sub-Saharan Africa (5/13, 38.5% vs. 111/937, 11.8%; p=0.0143), had exclusively non-industry sponsorship (13/13, 100% vs. 559/937, 59.7%; p=0.0025), and inclusion varied by study phase, randomization level, and intervention type.

Sources - https://www.sciencedirect.com/science/article/abs/pii/S258993332200132X