It was a terrifying time. Little was known about the virus called SARS-CoV-2 to begin with, much less how it might affect a pregnancy, so doctors had to make tough calls She remembers doctors getting waivers to administer the antiviral drug remdesivir to pregnant COVID-19 patients, for instance, even though the drug hadn’t been tested during pregnancy.
“Our goal is to help the mom,” she says, “If we had something that might save her life — or she might die — we were 100 percent using all of those medications”
These life-or-death decisions were very familiar to obstetricians even before the pandemic. Pregnant women have long been excluded from most drug testing to avoid risk to the fetus As a result, there’s little data on whether many medications are safe to take while pregnant. This means tough choices for the roughly 80 percent of women who will take at least one medication during pregnancy. Some have serious conditions that can be dangerous for both mother and fetus if left untreated, like high blood pressure or diabetes
“Pregnant women are essentially like everybody else,” she says They have the same underlying conditions, requiring the same drugs In a 2013 study, the top 20 prescriptions taken during the first trimester included antibiotics, asthma and allergy drugs, metformin for diabetes, and antidepressants Yet even for common drugs, the only advice available if you’re pregnant is “talk to your doctor.” With no data, doctors don’t have the answers either,
What’s frustrating to many doctors and researchers is that this lack of information is by design. Even the later stages of most clinical trials, which test a new drug’s safety and efficacy in people, specifically exclude pregnant people to avoid risk to the fetus, But in the wake of a pandemic that disproportionately harmed the pregnant population, researchers are questioning more than ever whether this is the best approach.
Typically, researchers have to justify excluding certain groups, such as older adults, from clinical trials in which they might benefit. “You never have to justify why you’re excluding pregnant people,” says she, who now heads the obstetrics, gynecology and reproductive science department at the University of California, San Diego. You can just go ahead and exclude them.
“The exclusion of pregnant people in clinical trials is a huge, historic problem,” she says, “and it really came to light with COVID.”
Teresa Mathews was 43 years old when she found out she was pregnant in June 2020, just as the pandemic was tearing across the United States “I was really worried,” she says In addition to her age as a risk factor, Mathews has sickle cell trait, meaning she carries one defective gene copy that makes her prone to anemia and shortness of breath. COVID-19 also causes shortness of breath, so Mathews feared her unborn child could starve for oxygen if she caught the virus
What’s more, the baby would be her first. “I don’t want to say it melodramatically, but it was my last chance of having a baby, right? So I didn’t really want to take chances” She went into full lockdown for the rest of her pregnancy
For good reason. A study during the pandemic’s first year in England found that pregnant women who got the virus were about twice as likely to have a stillbirth or early birth. And the U. S Centers for Disease Control and Prevention reported in November 2020 that pregnant women are about three times as likely as other women to land in intensive care with COVID-19, and 70 percent more likely to die from the infection (SN Online: 2/7/22)
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