Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Sumitomo Pharma Switzerland GmbH
Summary
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.
Description
The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency. Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 mo…
Eligibility
- Age range
- 0+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Woman of any age * Currently or recently pregnant * Consent to participate * Authorization for her HCP(s) to provide data to the registry Cohort 1 * Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy Cohort 2 * Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy Exclusion Criteria: The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population: * Occu…
Interventions
- DrugRelugolix-Containing Product
Any relugolix-containing therapy
Location
- PPDWilmington, North Carolina