Establishment of the National Pregnancy Registry for Atypical Antipsychotics.

Abstract

Atypical antipsychotics are widely used by reproductive-age women to treat a spectrum of psychiatric illnesses. Despite widespread use of this class of agents in women of childbearing potential, reproductive safety data across these medicines remain limited. The National Pregnancy Registry for Atypical Antipsychotics (NPRAA) at Massachusetts General Hospital was established in 2008 to address this knowledge gap. Data are prospectively collected from pregnant women, ages 18-45 years, using 3 phone interviews conducted at the following times: (1) proximate to the time of enrollment, (2) 7 months' gestation, and (3) 2-3 months postpartum. Subjects include pregnant women with histories of fetal exposure to second-generation antipsychotics and a comparison group of nonexposed pregnant women. Medical record release authorization is obtained for obstetric, labor and delivery, and newborn pediatric (up to 6 months of age) records. Information regarding the presence of major malformations is abstracted from the medical records along with other data regarding neonatal and maternal health outcomes. Identified cases of congenital malformations are sent to a dysmorphologist blinded to drug exposure for final adjudication. As of May 2014, 428 subjects have enrolled in the NPRAA. Efforts continue to increase enrollment for the purpose of enhancing the capacity to define risk estimates of in utero exposure to atypical antipsychotics. The NPRAA gathers prospective data regarding risk for critical outcomes following use of atypical antipsychotics during pregnancy. The NPRAA offers a systematic way to collect reproductive safety information that informs the care of women who use these agents to sustain psychiatric well-being. ClinicalTrials.gov identifier: NCT01246765.