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NCT04977466
NIH Intramural Research Program s Pregnancy Registry Protocol for Subjects and Their Partners
trial in Pregnancy Outcome in 500 participants. Enrolling by invitation.
30 December 2045
Quick facts
| Lead sponsor | National Institutes of Health Clinical Center (CC) |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 5 June 2023 |
| Primary completion | 30 December 2045 |
| Estimated completion | 30 December 2045 |
| Sites | 1 location across United States |
Conditions studied
- Pregnancy Outcome — all drugs for Pregnancy Outcome →
Sponsor
National Institutes of Health Clinical Center (CC)
Who can join
Adults 1 Day to 100, any sex, with Pregnancy Outcome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04977466
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institutes of Health Clinical Center (CC) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04977466 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
- Last refreshed: 23 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04977466.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing