Multi-country, non-interventional cohort study.The objective of the study is to characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD (used as a treatment or prophylaxis) among women of child-bearing indicated for such treatment in the real-world setting, using secondary data from US, France and Canada.
This is a multi-country, non-interventional cohort study in pregnancies exposed to EVUSHELD and pregnancies unexposed to EVUSHELD among women eligible for EVUSHELD. The study will be conducted within secondary data sources (administrative claims, electronic medical records (EMR) and/or registry data). For each country, the overall study period will span 12 months prior to the country-specific EVUSHELD availability until the end of the data cut or 31 March 2027, whichever is earlier. The study will include pregnancies in individuals eligible for EVUSHELD therapy in each country in the selected datasets, including pregnant individuals aged 18 to 49 years with a high-risk condition documented in the 12 months prior to the start of the pregnancy, defined as the first day of the last menstrual period (LMP).
Study Type
OBSERVATIONAL
Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation
Spontaneous abortion, Ectopic pregnancy
Time frame: Index date to < 20 weeks of gestation
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured anytime during pregnancy
Maternal Death
Time frame: Index date to end of pregnancy (Note: Maternal death outcome ascertainment period is up to 42 days after the end of pregnancy episode (EPE).)
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured after 20 weeks gestation
Preterm live birth, Stillbirth, Gestational hypertension, Pre-eclampsia, Gestational diabetes
Time frame: Index date to end of pregnancy Note: For preterm birth, the outcome ascertainment period is 20 to 37 weeks of gestation
Risk of outcomes in neonates potentially associated with exposure anytime during pregnancy and measured 28 days after birth
Low birth weight, Small for gestational age, Respiratory distress syndrome in the newborn, Neonatal death
Time frame: Diagnosed within 28 days of birth
Risk of outcomes in infants potentially associated with exposure anytime during pregnancy and measured within 12 months after birth
Major congenital malformations, Infant death, Failure to thrive
Time frame: From birth to time of death or 12 months of age
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