National Pregnancy Registry for Psychiatric Medications
This registry is studying the safety of psychiatric medications like antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics when taken during pregnancy. The goal is to understand if these medications increase the risk of major birth defects (malformations) in babies. We are looking for pregnant women between 18 and 45 years old who are currently taking psychiatric medications. You cannot join if you have already given birth, are planning to become pregnant, or are not taking psychiatric medications. The study will look at whether babies exposed to these medications have more major malformations than babies in the general population, with information collected from birth up to one year of age.
- Study design
- This is an observational study aiming to enroll 5000 pregnant women. It is not a treatment study but rather collects information about medication use during pregnancy.
- What's involved
- You will be asked to participate over the phone and provide informed consent.
- Compensation
- Not stated in the trial record.
- Follow-up
- Information about your baby's health will be collected from birth up to one year of age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
National Pregnancy Registry for Psychiatric Medications
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lee S Cohen, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Major Malformations in InfantsBirth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives.