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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Jul 24, 2021

Keywords

ClinConnect Summary

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 d...

Gender

ALL

Eligibility criteria

• * 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