NIH launches pregnancy registry to monitor research product safety
NCT ID NCT04977466
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study creates a pregnancy registry for people who took part in NIH clinical trials and became pregnant during or within one year after the study. Researchers will collect health and birth information through interviews and medical records to monitor outcomes after unplanned exposure to research products. No treatment is given; the goal is to gather safety data.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2045
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants of NIH IRP protocols.
- Ages
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1 day to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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