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NCT07915232
A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab
Conditions: Pregnancy Related, Pregnancy, Pregnancy High-risk
Sex: Female
Healthy volunteers: No
Enrollment: 162
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to find out how often:
* Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy.
* Serious infections occur in newborns and infants born to participants who took nipocalimab just before or during pregnancy.
* Babies are born with major birth defects (not related to chromosomes) in pregnancies where nipocalimab was taken just before or during pregnancy.
Eligibility Criteria
Inclusion Criteria:
\- Documented exposure to least one dose of nipocalimab any time immediately before ( 1 week \[7 days \] before estimated date of conception) or during pregnancy in the post-marketing setting
Exclusion Criteria:
* Reports in which the pregnant person discontinued nipocalimab 1 week (7 days) before the estimated date of conception
* Indirect case reports (reported by someone other than the patient or the health care provider \[HCP\]) for which the reporter refuses to provide follow-up information, and the participants or HCP cannot be identified based on the information provided
* Case lacking reporter contact details
* Cases where only the father/male partner is exposed to nipocalimab during partner's pregnancy
* Cases occurring in an interventional setting (that is, clinical trials)
Source: ClinicalTrials.gov (NCT07915232). StuddyBuddy aggregates publicly available trial information.