Registry to evaluate psychiatric medications during pregnancy
National Pregnancy Registry for Psychiatric Medications
This study is trying to see if using certain psychiatric medications during pregnancy is safe for both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01246765 on ClinicalTrials.gov |
What this trial studies
The National Pregnancy Registry for Psychiatric Medications aims to assess the safety of various psychiatric medications, including antidepressants and atypical antipsychotics, used by pregnant women. This observational study will systematically document medication exposure during pregnancy and evaluate the associated risks of congenital malformations and neonatal outcomes. By gathering comprehensive data, the registry seeks to provide clinicians with reliable information regarding the reproductive safety of these medications, which is currently limited. This initiative represents one of the largest hospital-based efforts to monitor pregnancy outcomes related to psychiatric medication use.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-45 who are currently taking psychiatric medications.
Not a fit: Women who have completed their pregnancy or are planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide critical insights into the safety of psychiatric medications during pregnancy, guiding treatment decisions for expectant mothers.
How similar studies have performed: While there have been smaller studies on medication safety during pregnancy, this registry represents a novel and comprehensive approach to systematically evaluate the risks associated with psychiatric medications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women * Age 18-45 * Subjects will be willing to participate over the phone * Subjects will be able to provide informed consent Exclusion Criteria: * Women who have completed their pregnancy * Women who are planning to become pregnant * Women who are not taking any psychiatric medications and/or have no history of psychiatric illness
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Lee S Cohen, MD — Massachusetts General Hospital
- Study coordinator: Bryn Rediger
- Email: brediger@partners.org
- Phone: (617) 724-8020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.