Related Experiment Video
Updated: Feb 6, 2026
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Risk of Major Malformations in Infants Following First-Trimester Exposure to Quetiapine
Lee S Cohen1, Lina Góez-Mogollón1, Alexandra Z Sosinsky1
1From the Department of Psychiatry and the Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston; Harvard Medical School, Boston; the Neurological Institute, Cleveland Clinic, Cleveland; the Prenatal Diagnosis and Medical Genetics Program, Mount Sinai Hospital, Toronto; and the Harvard T.H. Chan School of Public Health, Harvard University, Boston.
Objective:
Second-generation antipsychotics are commonly prescribed to reproductive-age women for the treatment of a spectrum of psychiatric disorders. Quetiapine is the most commonly prescribed medication in this class, and therefore a better understanding of its reproductive safety profile is critical. The goal of this study was to determine the risk of major malformations among infants exposed to quetiapine during pregnancy compared with a group of infants whose mothers had a history of psychiatric morbidity but who did not use a second-generation antipsychotic during pregnancy.
Method:
The National Pregnancy Registry for Atypical Antipsychotics interviews pregnant women ages 18-45 during pregnancy and the postpartum period. Obstetric, labor, and delivery medical records and pediatric medical records from the first 6 months of life were screened for evidence of major malformations, followed by adjudication by a blinded dysmorphologist. Women with first-trimester exposure to quetiapine were compared with control subjects without exposure to second-generation antipsychotics.
Results:
As of March 2017, 888 women had enrolled prospectively and 357 were eligible for analysis. Of these, 152 women with first-trimester exposure to quetiapine were compared with 205 control subjects without any second-generation antipsychotic exposure. For the 155 infants born to women in the exposed group (including three sets of twins), two major malformations were confirmed (1.3%), compared with three major malformations among the 210 infants born in the unexposed group (including five sets of twins) (1.4%). The unadjusted odds ratio for major malformations between infants with and without quetiapine exposure was 0.90 (95% CI=0.15, 5.46), which is consistent with the pooled estimate of the available controlled data on fetal exposure to quetiapine.
Conclusions:
These data regarding the safety of fetal exposure to quetiapine in a small sample of well-characterized participants are reassuring given that the confidence interval does not exceed a fivefold increased risk of major malformations relative to psychiatric control subjects. Future analyses based on ongoing data collection will produce more precise estimates.
More Related Videos
15:27Construction of Vapor Chambers Used to Expose Mice to Alcohol During the Equivalent of all Three Trimesters of Human Development
Published on: July 13, 2014
14:58Comprehensive Endovascular and Open Surgical Management of Cerebral Arteriovenous Malformations
Published on: October 20, 2017
Related Concept Videos
01:19Major Organs of the Digestive System
Gastrointestinal tract:
01:27Major Hormones and Their Functions
Oxytocin, produced in the hypothalamus and released by the pituitary gland, plays a role in social bonding, childbirth, and...
01:28Major Losses in Pipes
Fluid flow can be classified as laminar or turbulent, primarily based on the Reynolds number. This dimensionless number reflects the relative influence of inertial to viscous...
01:12Relative Risk
01:26Factors Affecting the Risk of Infection
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...
01:20Anatomy of the Brain: Major Regions
The cerebrum is the largest section of the brain and divides into left and right hemispheres, separated by a deep fissure. The cerebral outer layer of grey matter — the cerebral cortex — comprises elevations called gyri and shallow groves called sulci. The inner portion of white matter includes long nerve fibers known as axons, which connect...