Pregnant pause: Psych research and moms-to-be
Pregnant pause: Psych research and moms-to-be
Group looking for solutions to thorny ethical issues
Handling mental illness during pregnancy can be a double-edged sword. Because of the scarcity of clinical research with pregnant women, there are no FDA-approved medications for treating such illnesses. On the other hand, untreated mental illness in pregnancy carries its own risks. For example, depression has been associated with fetal growth problems, preterm birth, and longer stays in the NICU; untreated schizophrenia can lead to preterm birth, low birth weight and a greater chance of postnatal death.1
Doctors and patients urgently need the most complete information about the effectiveness of treatment alternatives, says Anna Brandon, PhD, assistant professor of psychiatry at the University of Texas Southwestern Medical School in Dallas. But because of ethical concerns, it has been difficult to conduct randomized, controlled trials with pregnant participants.
Brandon says she became aware of the constraints on research while conducting a study involving non-medication therapy with pregnant women and their husbands. "Then I became acquainted with a bioethicist and a few other folks and we started putting our heads together and saying, 'This is a problem that really hasn't been addressed,'" she says.
That group plans to conduct surveys on the attitudes of IRBs, researchers, community practitioners, and pregnant women regarding research. Their aim is the development of guidelines that would address the ethical issues surrounding mental health research during pregnancy.
"Psychiatric issues are different than other health issues in pregnancy, because they impair the mental and emotional functioning of the mom, which has secondary effects on the family, the fetus, and the baby," Brandon says. "So we feel it has to be viewed through a different framework than, say, looking at gestational diabetes, or gestational hypertension, which are serious illnesses but don't necessarily impair the woman's functioning with her baby."
Brandon says existing guidance for research with pregnant women is vague and often doesn't address the unique problems posed by mental illness. For example, the usual concerns about informed consent may not take into account a woman who is severely depressed and has difficulty with decision-making.
Brandon notes that the role of fathers, as outlined in human subjects protection regulations, isn't well fleshed out. "As it stands now, the pregnant woman is given the option to bring the father into play if he's competent, if he's involved, and if she identifies him. But it's still fairly contingent on the information she presents the researcher or the obstetrician about the father."
Concerns that pit the health of the fetus against the health of the mother can actually endanger the fetus more, she says. "Because if the mother suicides, the fetus dies, too."
The absence of more clear-cut guidelines leaves IRBs understandably wary about proceeding with such studies, even when medication is not involved. Often, Brandon says, they refuse to allow a control group with minimal intervention, despite the fact that there are few proven therapies for pregnant women with mental illness.
Brandon says one colleague wanted to randomize some women to a psycho-education group and others to an exercise intervention. The IRB would not allow that randomization unless the psycho-education group also did a low-intensity exercise regimen.
"So now what [the researcher] has is one condition where women walk on a treadmill with their heart-rate being monitored and another condition where women stretch. And we're not going to know whether the active intervention is really working."
Brandon says her group is not suggesting a full-scale rush to do randomized, controlled trials with depressed pregnant women who may be assigned to no treatment. What she does suggest is a discussion to look at instances in which a no-treatment condition may be appropriate, with safeguards.
"We need to start sorting some of these things out and come up with a framework for balancing the decision," she says. "Until we have that, we have IRB administrators, perinatal investigators, funding agencies, patients, community clinicians — we have everyone operating under this cloud of 'We're afraid to do anything unless it's appropriate' and yet there's no standard for what's appropriate."
A five-year process
In an effort to achieve this goal, Brandon and her colleagues — psychiatrist Geetha Shivakumar, medical anthropologist and public policy expert Simon Lee, medical historian Stephen Inrig and bioethicist John Sadler — are setting out to learn about the concerns and attitudes of perinatal researchers and IRBs.
Brandon says her group, which is currently funded by the National Institute of Mental Health, hopes to get another grant that would allow it to take the conversation to other sites, and to include practitioners and participants as well, with the eventual goal of collaborative guidelines.
"I think guidelines are most effective when everyone feels like they've had a hand in crafting them," she says. "Our idea is that they would get put forth collaboratively and then adopted by (the American College of Obstetricians and Gynecologists), adopted by the IRBs, adopted by research investigators who all feel they had a part in crafting them."
The process of creating guidelines could take five years or longer, in order to ensure that all the stakeholders are included, she says. "I'm sure a set of guidelines isn't going to answer all the questions or solve the dilemma, but I think the dialogue has to be opened up."
As part of that dialogue, Brandon encourages IRB members who have ideas, questions or "provocative comments" to contact her at [email protected].
- Brandon AR, Shivakumar G, Lee SL, et al. Ethical issues in perinatal mental health research. Curr Opin Psychiatry 2009 Sep 2 [Epub ahead of print]
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