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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT04977466
Status
Enrolling By Invitation

Conditions

  • Pregnancy Outcome

Eligibility Criteria

Sex
ALL
Age
1 Day - 100 Years
Healthy Volunteers
Accepted

Study Details

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 Dates

Start date
Jun 5, 2023
Status verified
Feb 2026
Primary completion
Dec 30, 2045
Completion
Dec 30, 2045

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Group #1 / Pregnant Female NIH Participants
    Female NIH study participants.
  • Arm: Group #2 / Male and Female Partners
    Male or female partners of women who participated in NIH intramural clinical trials and that became pregnant.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Enrollment of the last study subject [ Time Frame: End of study ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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