The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to post-exposure pregnancy and fetal and neonatal outcomes. The objective of the Registry is to monitor and evaluate all received reports of PREHEVBRIO® vaccine exposure within 28 days prior to conception or at any time during pregnancy and delivery, as well as maternal, obstetrical, pregnancy, fetal and neonatal outcomes. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.
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Rate of spontaneous abortion
Timeframe: Less than 20 weeks of gestation, measured from the day of conception to the day of abortion
Rate of major congenital malformations
Timeframe: From enrollment until 3 months post-delivery