The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.
Woman of any age
Currently or recently pregnant
Consent to participate
Authorization for her HCP(s) to provide data to the registry
Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
Exposure to known teratogens and/or investigational medications during pregnancy
Lost to follow-up
The study population will include 2 cohorts of pregnant women: one cohort exposed to relugolix-containing therapy and one cohort of women with conditions for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix-containing therapy.
Cohort
Prospective
Relugolix-Containing Product
DrugAny relugolix-containing therapy
Major Congenital Malformation (MCM)
Comparison of rate of MCM between cohorts
Minor congenital malformations
Comparison of rate of minor congenital malformations between cohorts
Spontaneous abortion (SAB)
Comparison of rate of SABs between cohorts
Stillbirth
Comparison of rate of stillbirths between cohorts
Elective termination
Comparison of rate of elective terminations between cohorts
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