The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs.
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.