Abstract

Pregnant women are often excluded from drug trials out of concern for harm to the fetus or infant. Early on in the COVID-19 pandemic, pregnant women were not included in drug or vaccine trials. We examined how many pregnant women with COVID-19 reported in the published literature had participated in randomised trials, and what treatments they still received outside such trials. We searched two clinical trial registries to identify COVID-19 trials open to pregnant women. 156 studies were then extracted from a database of the published literature. Of the reported 43,185 pregnant women with COVID-19, 2,671 (6%) were potentially eligible for a randomised trial but only seven women (0.3%) were reported to have enrolled. For 2,839 women the papers reviewed included information on treatment received, and 54% women had received ? 1 treatment outside of a trial. In 44% cases the treatments administered to the pregnant women were not recommended by the National Institutes of Health (NIH). During the early phase of the COVID-19 pandemic, pregnant women were excluded from randomised clinical trials despite being eligible clinically. They still received unproven or ineffective COVID-19 treatments. Consideration must be given to the inevitable damage caused by excluding a population from research.