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

NCT04977466 | Enrolling By Invitation

• 2 other identifiers: 10000268000268-CC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Outcome

Keywords

Partner; Intramural Research Program; OFFSPRING; Registry; Delivery; Natural History

Outcome Measures

Primary Outcomes (1)

• Enrollment of the last study subject

  The only outcome of the study is to enroll all study stubjects.

  End of study

Study Arms (4)

Group #1 / Pregnant Female NIH Participants

Female NIH study participants.

Group #2 / Male and Female Partners

Male or female partners of women who participated in NIH intramural clinical trials and that became pregnant.

Group #3 / Pregnant Female Partners of Male or Female NIH Clinical Trial Partici

Female partners of NIH intramural clinical trial participants who became pregnant while their partner was or within 1 year after the last day of intervention after their partner was on a study.

Group #4 / Neonate or Offspring of a Pregnant Female Participant or Pregnant Fe

Offspring from birth to 12 months of age and born to female participants / female partners.

Eligibility Criteria

• Age: 1 Day - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of NIH IRP protocols.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• All Participants
• Able and willing to provide written informed consent for study participation.
• Stated willingness to comply with all data collection study activities
• Male or female, aged 0-100 years
• Participant or partner of a participant on NIH protocol
• Group #1 (Pregnant Female NIH Participants)
• Female NIH study participants with a confirmed pregnancy that occurred during or within 1 year after the last day of intervention during participation in NIH intramural clinical trials AND that meet at least one of the following criteria/assessments:
• Positive pregnancy test (serum or urine)
• Auscultation of fetal heart tones
• Clinical assessment of fetal movement
• Demonstration of pregnancy by ultrasound
• Group #2 (Male and Female Partners)
• Male or female partners of women who participated in NIH intramural clinical trials and that became pregnant while they were on study or within 1 year of the last day of intervention.
• Group #3 (Pregnant Female Partners of Male or Female NIH Clinical Trial Participants)

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Virginia A Guptill, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 27, 2021
• Study Start: June 5, 2023
• Primary Completion (Estimated): December 30, 2045
• Study Completion (Estimated): December 30, 2045
• Last Updated: February 23, 2026

Record last verified: 2026-02-19

Locations

US (1)