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Research with pregnant women still lags due to fears for fetuses
Reluctance can impede vital research to help women
Despite general agreement that medicine and medical research need to do more to meet the needs of pregnant women, there still are serious roadblocks that prevent wider enrollment of women during pregnancy.
The overriding concern about protecting a developing fetus can keep important studies – studies that could benefit both women and their children – from ever going forward, says Ruth Faden, PhD, MPH, director of the Johns Hopkins Berman Institute of Bioethics in Baltimore, MD.
Faden, who helped author a recent paper in The International Journal of Feminist Approaches to Bioethics, compares the dilemma to that of trying to bring about pediatric research.
"There is a significant chunk of people who have health needs in pregnancy and we don't know nearly as much about how to take care of them effectively as we do for other groups of people," Faden says. "In that sense, it is directly analogous to the claims that were made with regards to pediatrics.
"The notion of protecting children ended up being inimical to their interests," she says. "And we argue that protecting pregnant women (from participating in research) is inimical to their interests and also to the interests of their babies. Nobody wins."
She and her co-authors recommend a number of steps – including improved guidance for IRBs – to help incorporate pregnant women more fully into clinical research.
The Institute of Medicine's 1994 report on the inclusion of women in research recommended that pregnant and lactating women be considered eligible for research, effectively reversing the existing presumption that they should be excluded.
Current federal regulations (45 CFR 46 Subpart B) allow pregnant women to participate in research if it holds out some prospect of direct benefit to the woman, the fetus or both, or barring that, does not subject the fetus to greater than minimal risk.
However, there's been little progress since the IOM report in actually increasing the number of studies conducted with pregnant women, write Faden and her coauthors: "…many researchers and institutional review boards (IRBs) continue to regard pregnancy as a near-automatic cause for exclusion, regardless of the costs of exclusion or the magnitude or likelihood of the risks of participation."
And those costs are real ones, Faden says. Because of reluctance to do research with pregnant women, little is known about how best to treat them when they have existing conditions such as hypertension, diabetes, cancer and psychiatric illness. In addition, conditions of pregnancy such as extreme nausea, and preeclampsia are understudied.
Just as women are not like men in their responses to medicine and children are not simply "little adults," pregnant women are unlike even other women in how they are affected by drugs. Pregnancy can affect the absorption and excretion of drugs in ways that can be hard to predict. It's also unknown exactly how most drugs affect a developing fetus.
Despite those uncertainties, pregnant women do take drugs – one study showed that two-thirds of pregnant women took four to five medications during pregnancy and labor.
Faden notes that those women represent an opportunity to researchers; because they already have shown themselves willing to take medication during pregnancy, they could participate in a study of the medicine with no more additional risk than a simple blood draw.
Encouraging such opportunistic studies – what Faden and her colleagues call "low-hanging fruit" – is one of the steps that they recommend in their paper.
"If various funding agencies announce this is an initiative where they'd like to see work, and they release RFPs, work will be done," she says.
She and her co-authors also want to see more research into the public health impact of the lack of knowledge about the effects of medication on pregnant women and their babies. Those studies could help answer questions about what priorities should be set in pregnancy research. For example, is there a health cost to requiring that pregnant women continue to use older drugs for conditions such as hypertension rather than studying the effects of newer drugs?
Faden's colleagues recommend better guidance for IRBs to help them recognize the possible harms of excluding pregnant women from studies, and determine what are and are not reasonable justifications for excluding them.
While it's taken a long time to get to this point, Faden thinks the timing is right for there to be a concerted effort on this issue, because even those who disagree on other issues such as abortion can agree on this.
"No doubt this issue has been tied up with our deep moral disagreement about how to think of early human life – to think otherwise is just silly," she says. "But there's nobody who doesn't think it's a good thing if we know better about how to improve the health of pregnant women and how to protect the health interests of babies. Nobody is going to argue against that."