Global Safety Study on Pregnancy and Breastfeeding Outcomes After Exposure to Efgartigimod

What this Trial Is About

This research aims to evaluate the safety of efgartigimod or efgartigimod PH20 SC exposure in pregnant women and breastfeeding mothers across multiple countries. It focuses on monitoring maternal, fetal, and infant outcomes related to these exposures, including rates of major congenital malformations. The study collects background data from similar populations for comparison. Participants include women who were exposed to efgartigimod or efgartigimod PH20 SC within 25 days before conception, during pregnancy, or exclusively during breastfeeding. Women who are no longer pregnant at enrollment but had prior exposure are included, as well as those currently pregnant or breastfeeding. During the study, researchers will observe pregnancy outcomes, congenital malformations, fetal growth issues, maternal complications and infections, and serious illnesses in newborns and infants. These outcomes will be tracked for up to 10 years, providing long-term safety data. Participants provide consent and are monitored through routine data collection without assigned treatments.

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.