NIH Intramural Research Program s Pregnancy Registry Protocol for Subjects and Their Partners

Enrolling by invitation

Conditions studied: Pregnancy Outcome

In brief

Background: In 2018, the NIH intramural research program had almost 23,000 people taking part in active clinical research studies. Half of those people were female. More than a third were of child-bearing age. Researchers want to use data from this group to create a pregnancy registry. It will be used to collect data about pregnancy and birth outcomes related to unplanned exposure to research products. These products may include drugs, vaccines, treatments, and interventions. Objective: To collect data about pregnancies and births from people who took part in an NIH clinical trial and their partners who became pregnant while in the study or shortly after. Eligibility: People of any age and their partners who took part in an NIH clinical trial and became pregnant while in the study or within 1 year after. Design: Participants will be screened by phone. Their clinical trial history will be verified. Participants will be interviewed in person, by phone, or virtually. They will be asked about their health and their trial experience in relation to their pregnancy. They will give details about their pregnancy and baby (if appliable). They will be interviewed every 6 months for 1 year after the birth of their baby, as applicable. Data from both NIH and outside medical records will be used. Participants will give their doctor s name and contact details. They will provide a release for their records to be used. If needed, they will provide a release for their baby s records. Data will be coded and stored in a database on an in-house NIH secure server. Data may be used in future studies

Key facts

Study ID

NCT04977466

Run by

National Institutes of Health Clinical Center (CC)

People needed

500

Starts

2023-06-05

Expected to finish

2045-12-30

Last updated by the study team

2026-02-23

Who can join

Age: 0 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Participation in NIH research studies that do not meet criteria of a clinical trial, such as natural history or observational studies
• Pregnancy that occurs/occurred more than 1 year after NIH clinical trial participation

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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