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

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.