Inclusion of pregnant women in COVID-19 treatment trials: a
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Pregnant women are among those most in need of safe and effective therapies against COVID-19, but they are routinely excluded from the majority of clinical treatment trials, according to authors of an opinion piece based on a review of international trial registry data, published in The Lancet Global Health journal. Strikingly, three-quarters of COVID-19 trials reviewed specifically excluded expectant mothers, even though they were investigating medications and vitamins that already have a relatively favorable safety profile during pregnancy, or that are already used in pregnant women.

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. Researchers explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two-time points in 2020. They identified 155 COVID-19 treatment studies of non-biological drugs for the April 7–10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10–15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. Researchers then focused on studies that included at least one of six drugs (remdesivir, lopinavir–ritonavir, interferon beta, corticosteroids, chloroquine, and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women.

Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. The exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.