Scant clinical research for pregnant and lactating women with COVID-19

Pregnant and breastfeeding women have been excluded from clinical trials of drugs to treat COVID-19, and as result, there is no safety data to inform clinical decisions. Such drugs include remdesivir according to a new article in the peer-reviewed journal Breastfeeding Medicine.

Since pregnant and lactating women are not included in clinical trials, little is known about whether the drug transfers into breast milk and reaches the infant's circulation.

The lack of such data complicates a decision between giving lactating women a potentially life-saving drug and having them stop breastfeeding or risking any potential adverse effects of the drug on the infant, writes Alison Stuebe, MD, University of North Carolina School of Medicine and President of the Academy of Breastfeeding Medicine.

Suspending breastfeeding in mothers infected with COVID-19 could be detrimental because the infant is missing out on critical nutrients in human milk. Additionally, antibodies acquired from the mother may protect the infant against acquiring COVID-19.

"This quandary illustrates the consequences of longstanding policies to exclude pregnant and lactating women from clinical trials," Stuebe says. "Rather than excluding pregnant and lactating women from research, we must protect them through research."

Pregnant and breastfeeding women and their fetuses and infants cannot continue to be administrative orphans regarding new drug trials, and this situation warrants immediate correction."

Arthur I. Eidelman, MD, Editor-in-Chief of Breastfeeding Medicine