Pregnancy OutcomeNCT04977466
NIH Intramural Research Program s Pregnancy Registry Protocol for Subjects and Their Partners
An observational study of Pregnancy Outcome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 30 Dec 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants of NIH IRP protocols.
Who may be able to join
- 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
Show all 24Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Pregnancy Outcome
- Keywords
- Partner, Intramural Research Program, OFFSPRING, Registry, Delivery, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of the last study subject
The only outcome of the study is to enroll all study stubjects.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start5 Jun 2023
- Primary completion30 Dec 2045 (estimated)
- Study completion30 Dec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Virginia A Guptill, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977466
- Sponsor's protocol ID
- 10000268
- Other IDs
- 000268-CC
- Status last verified
- 19 Feb 2026
- First submitted
- 24 Jul 2021
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIH Intramural Research Program's Pregnancy Registry Protocol for Subjects and Their Partners
- ClinicalTrials.gov ID
- NCT04977466
- Acronym / sponsor ID
- 10000268
- Conditions
- Pregnancy Outcome
- Keywords
- Partner, Intramural Research Program, OFFSPRING, Registry, Delivery, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 30 Dec 2045 (estimated)
- Study completion
- 30 Dec 2045 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants of NIH IRP protocols.
Key inclusion criteria (24 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- All Participants
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enrollment of the last study subject
Time frame: End of study
The only outcome of the study is to enroll all study stubjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginia A Guptill, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Outcome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of the last study subject (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.