Pregnant Women Are Now Allowed to Participate In Covid-19 Studies
Researchers at the University of Pennsylvania are now allowing pregnant and lactating women to participate in convalescent-plasma trials for patients with COVID-19, according to a report by The Wall Street Journal.
Pregnant patients have not been studied much in drug and research trials, which leads to a lack of drug safety information specific to pregnant patients.
Pregnant and lactating patients were left out of the COVID-19 treatment trial conducted by the National Institute of Allergy and Infectious Disease. This, a spokeswoman explained, was because the effects of remdesivir on pregnant woman were unknown. She said that the agency is “exploring research opportunities related to Covid-19 treatments during pregnancy.”
While pregnant women were not participants in the early remdesivir trials, though, the dug was prescribed to many under compassionate-use guidelines when trying to save their lives.
In 2018, a task force advising the secretary of Health and Human Services recommended removing liability concerns and other obstacles for pregnant women’s participation in drug trials.
COVID-19 researchers and the Coalition to Advance Maternal Therapeutics have also expressed a need for pregnant women to take part in drug trials.
“If we don’t enroll them in trials, we won’t have therapies for them when they are sick,” says Katharine Bar, assistant professor of infectious diseases and principal investigator on the two convalescent plasma trials at the University of Pennsylvania.
Convalescent-plasma treatments were not developed by drugmakers, who are often reluctant to test on pregnant women, making their accessibility to these new trials easier. Pregnant women are also permitted to enroll in clinical trials of convalescent plasma underway in New York City for COVID-19 patients with respiratory symptoms.
The treatment appears to be generally safe to use for hospitalized adults with the virus according to a study conducted in May. Serious adverse effects occurred in less than 1 percent of the 20,000 patients aged 18-80 tested on.
Still, little is known about pregnancy and coronavirus, including whether or not the infection is transmitted to the baby. Dr. Bianchi says that “most people seem to think it does not,” but there are some case reports that support the opposite claim, so a definite conclusion cannot be reached yet.
Many researchers are looking to expand their testing trials to include pregnant women, including the University of California, San Francisco. The test there is meant to determine if infections in the first trimester have any effect on the pregnancy or development of the baby.
Read the full report here.