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Pregnant Women Excluded From Three-Quarters of COVID-19 Trials

Review of data in trial registries shows they specifically excluded this group from studies involving therapies.

In a new review of 10 WHO-recognized international clinical trial registries, data revealed that pregnant women were excluded from 80% (124) of 155 clinical treatment trials of COVID-19 registered in April, and 75% (538) of 722 trials in July.

“Without explicit and proactive efforts to recruit and retain pregnant women in therapeutic trials for COVID-19, expectant mothers will suffer from having fewer medical options available to them, because we are not including them in clinical trials,” author Melanie Taylor, MD, MPH, from WHO in Switzerland and the US Centers for Disease Control and Prevention, said. “There is a very real possibility that treatment could become approved for treatment of COVID-19 without evidence-based guidance for use in pregnant women.”

The findings were published in The Lancet Global Health journal.

The authors also reported this cohort was also excluded in three-quarters (130/176) of trials investigating six key therapies including: lopinavir/ritonavir, chloroquine and hydroxychloroquine, remdesivir, interferon beta, ivermectin, and corticosteroids.

Separately, the University of California San Francisco conducted a small study earlier this year looking at mothers infected with COVID-19 and newborns. The investigators reported very few adverse effects and low rates of COVID-19 transmission rates from mothers to newborns.

The authors also investigated the inclusion eligibility criteria for these trials and found that the principle researchers of these trials did not include an explanation for why pregnant women were excluded. They believe that pregnant women’s exclusion from COVID-19 trials is likely happening due to perceived risks around use in expectant mothers and medication exposure to foetuses or neonates.

“Categorizing women as members of a vulnerable group on the basis of pregnancy status alone, rather than as individuals who are pregnant at the time of the trial, limits their individual choice, and access to potentially life-saving treatment,” Caron Kim, MD, one of the authors from WHO and HRP in Switzerland, stated.