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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy Outcome

Detailed Description

Study Description:

This protocol will serve as a pregnancy registry to collect prospective and retrospective health information from current and former NIH intramural research participants, their partners and offspring that became pregnant during or within 1 year after participating in an NIH intramural clinical trials. The registry will provide supplemental data on outcomes of clinical trial interventions on pregnancy and delivery of offspring as this information is seldom available because pregnant women are often immediately excluded from study participation upon becoming pregnant and data from women who became pregnant and their offspring outcomes is not systematically or routinely collected and evaluated in the intramural program at the NIH. Partners of women who became pregnant within 1 year following research study participation in clinical trials will be invited to participate to evaluate if participation in clinical trials extends to those in close contact.

Objective:

To collect information about pregnancy and offspring outcomes from NIH intramural clinical trial participants and/or partners of current and former NIH research participants.

Study Population:

Adult participants:

Females that participated in NIH intramural clinical trials and became pregnant while on study or within 1 year after.

Male or female partners of women that participated in NIH intramural clinical trials that became pregnant while they were on study or within 1 year after.

Female partners of NIH intramural clinical trials participants that became pregnant while their partner was or within 1 year after their partner was on a study.

Offspring from birth to 12 months of age and born to:

Females that participated in NIH intramural clinical trials and became pregnant while on study or within 1 year after.

Male or female partners of women that participated in NIH intramural clinical trials that became pregnant while they were on study or within 1 year after.

Female partners of NIH intramural clinical trials participants that became pregnant while their partner was or within 1 year after their partner was on a study.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants of NIH IRP protocols.

Description

• INCLUSION CRITERIA:

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)

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 AND who 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 #4 (Neonate or Offspring of a Pregnant Female Participant or Pregnant Female Partner)

Offspring from birth to 12 months of age and born to:

• Females who participated in an NIH intramural clinical trial and became pregnant while on study or within 1 year after.
• Female partners of women or men who participated in an NIH intramural clinical trial who became pregnant while they were on study or within 1 year after.

EXCLUSION CRITERIA:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment of the last study subject	The only outcome of the study is to enroll all study stubjects.	End of study

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Virginia Guptill, Ph.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Estimated): December 30, 2045
• Study Completion (Estimated): December 30, 2045

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 24, 2023

More Information

Terms related to this study

• Keywords: Natural History; Registry; Partner; Intramural Research Program; OFFSPRING; Delivery
• Other Study ID Numbers: 10000268; 000268-CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No