PETUNIANCT07915232
A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab
StatusNot Yet Recruiting
PhaseNot specified
Primary completion (estimated)
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Prevalence of Fetal Growth Restriction
Timeframe: During pregnancy (Up to Week 42)
Prevalence of Small for Gestational Age
Timeframe: At birth
Prevalence of Hypertensive Disorders of Pregnancy
Timeframe: From 20 weeks gestation through 6 weeks postpartum
Prevalence of Placental Abruption
Timeframe: During pregnancy (Up to Week 42)
Prevalence of Serious Infections in Neonates
Timeframe: Birth to 27 days
Prevalence of Serious Infections in Infants
Timeframe: 28 days to 365 days after birth
Prevalence of Non-chromosomal Major Congenital Malformations
Timeframe: During pregnancy (up to Week 42) and up to 1 year after birth
Secondary (8)
Prevalence of Live Birth
Prevalence of Spontaneous Abortion
Prevalence of Stillbirth
Prevalence of Preterm Birth
Prevalence of Intrapartum Hemorrhage
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Prevalence of Postpartum Hemorrhage
Prevalence of Neonatal Death
Prevalence of Infant Death
Arms and interventions
Participants Exposed to Nipocalimab Immediately Before or During Pregnancy
Participants with documented exposure to at least one dose of nipocalimab any time immediately before (within 1 week \[7 days\] before estimated date of conception) or during pregnancy in the post-marketing setting. No drug will be administered as a part of this study. Participants received nipocalimab as per their routine clinical practice settings.