Evidence-Based Pregnancy Registries: Good for Babies and Their Mothers

It has been 25 years since the National Institutes of Health (NIH)Office of Research onWomen’sHealthwas founded to redress the dearth of health outcomes research in women. Since that time, to answer the need for science-based information onwomen’s health needs, the office has focused on ensuring the unbiased inclusion of NIH-sponsored clinical trials into women’s health research. In 2010, following a series of scientific regional workshops and public hearings, the office released adocument titled, “Moving into theFuture with New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research” (2). Among the objectives recognized and set forth was research on conditions affecting pregnantwomenand their effects on the subsequenthealthof women and their offspring. Of the more than four million women in the United States who give birth annually, many suffer from serious mental disorders, including depression, bipolar disorder, schizophrenia, and anxiety disorders. Nevertheless, there continues to be a lack of evidence-based research on the effects of psychiatric medications on the health ofwomenand exposedoffspring. Thus, the decision to treatpregnantwomenwithpsychotropicmedications isoften made by health care providers with little or no evidencebaseddata, andwhoseoverridingconcern ison theprotection of the fetus,with far less consideration given to thehealth and well-being of the expectant mother (1). As a result, despite suffering, pregnant women with psychiatric illness are often denied potentially effective treatment that may reduce both their suffering and the adverse effects of their illness on the health of their offspring. The placing of fetal concerns over those of the pregnant woman has been described as “cultural anxiety” (3), and risk/benefit concerns often remainweighted heavily toward the safety of the fetus, ignoring the growing evidence that the health of the pregnant woman is connected inexorably to that of her fetus, and vice versa. Thus,despiteampleresearch thatpsychiatric illnessduring pregnancy increases the risk not only of maternal illness but also of obstetrical complications and adverse fetal outcomes (4–11), clinicians continue to be wary of prescribing psychotropic medications to pregnant women. Fortunately, over the past 2 decades, there has been considerable progress supporting the relative safety and efficacy of antidepressant use in pregnancy (particularly selective serotonin reuptake inhibitors), as well as research bringing attention to the risks of the use of mood stabilizers such as lithium, sodium valproate, and carbamazepine in pregnancy. However, there has been a lag in research on the use of antipsychotic agents (specifically newer second-generation antipsychotics, or atypical antipsychotics) in pregnancy. These agents are now frequently prescribed to treat primary psychotic illnesses such as schizophrenia, as well as bipolar disorder, and as augmenting agents for treatmentresistantmajordepressive disorders. At times, atypical antipsychotics have also been administered off-label to address debilitating anxiety and sleep deprivation.Cliniciansand their patients need to have access to information that will enable them to weigh the possible effects of untreated or undertreated illness on mother and baby against those of second-generation antipsychotics. In this issueof theJournal, Cohenandcolleagues reporton data prospectively derived from the National Pregnancy Registry for Atypical Antipsychotics, based at Massachusetts General Hospital (12). Recognizing the rigor and design of this registry, the Food and Drug Administration (FDA) has included it in the List of Pregnancy Exposure Registries (13). Although preliminary, the results of the study are encouraging and suggest that second-generation antipsychotics as a group are not major teratogens, unlike sodium valproate, which is often used to treat bipolar disorder and incurs an approximate 10% risk of neural tube defects. The registry, which continues to collect data, reports on results of 214 pregnant women exposed to a second-generation antipsychotic and an internal comparison group of 89 women with psychiatric illness who were not exposed to the studied agents.Medical records, obstetric records, labor and delivery data, and pediatric documentation (from birth to 6 months) were obtained, and malformations were reviewed by an independent, blinded dysmorphologist. There were three Clinicians and their patients need to have access to information that will enable them to weigh the possible effects of untreated or undertreated illness on mother and baby against those of second-generation antipsychotics.