Ethicists urge inclusion of pregnant women in Federal child-health study

A team of ethicists from Johns Hopkins, Duke and Georgetown universities is urging organizers of a recently begun $3 billion decades-long study of children's health to immediately add provisions to look at the health and medical profiles of the children's mothers during their pregnancies.

"We argue that the National Children's Study is an extraordinary opportunity to study one of the most underrepresented groups in clinical research, pregnant women," says Ruth Faden, the study's senior author and director of Johns Hopkins Berman Institute of Bioethics. "This is an ethical no-brainer. It's an easy, cost-efficient and uncontroversial way to advance the health of pregnant women, as well as the babies they bear."

Noting that results of the NCS are likely to guide children's health care treatment and policy for generations, Margaret Little, Ph.D., of the Kennedy Institute of Ethics at Georgetown University added, "the simple act of adding a few key questions on medication usage to the interviews and blood draws already scheduled can lead to a wealth of information."

"It is unjust for pregnant women to continue to benefit less than the rest of us from our enormous national effort to improve health through medical research, an injustice that is only underscored in the NCS given that enrollment of pregnant women is central to the success of the study," the team of authors said in an article published in the July 9 online issue of the American Journal of Public Health.

Including questions about pregnant women in the NCS could improve women's health during pregnancy and beyond, and reduce the anxiety of many women facing tough medical decisions during pregnancy-all without significantly increasing the study's costs or diverting attention from children's health, said Faden.

The NCS, which started earlier this year after nearly a decade of planning, is designed to track the effects of the many aspects of the environment on the health of more than 100,000 children from before birth to age 21. In order to enroll children even before birth, pregnant women (and in some cases, women prior to pregnancy) will be recruited in medical centers all over the country.

Many of the four million women who give birth each year in the United States face conditions that require medical treatment during pregnancy, but the drugs and other treatments prescribed for conditions ranging from high blood pressure to cancer to asthma are currently prescribed on the basis of research involving almost exclusively men and women who were not pregnant, raising questions about efficacy and safety for pregnant patients. Historically, testing drugs on pregnant women has been considered too risky to the fetus.

Although the Institute of Medicine recommended 15 years ago that pregnant women be involved in clinical research, many institutional review boards and researchers still exclude them because of ethical and liability concerns, even for studies that carry no risks.

Because of limited information about safety and efficacy in pregnant women, their medications are often cut back or halted altogether, even for serious medical conditions that preexisted or emerge during pregnancy-a practice that in itself may lead to significant harm to women and their fetuses, the article says.

"Pregnancy changes the body in dramatic and often unpredictable ways," said Anne Drapkin Lyerly, M.D., of Duke University, adding that previous studies show that pregnancy alters liver enzymes, concentrations of sex hormones and the speed with which drugs are metabolized by and excreted from the body. All of these changes mean that pregnant women may be getting too little of a drug to be effective, or too much of a drug to be safe.

Including pregnant women in clinical research has ethical complexities, but health care for the host of serious medical problems that pregnant women experience cannot be improved unless they are included at least in large observational studies that put the fetus at no risk, Faden said.

The NCS protocol has already been refined to include more information about the health of pregnant women and pregnancy outcomes, but virtually none of the data collection is currently designed to specifically address women's health risks and status over time, the authors said.

For example, the study will include blood sampling to analyze the effects of maternal medication use on the fetus, but the study as presently organized won't look at whether the medication is safe or effective for the woman herself or whether foregoing the medication compromises her health.