Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

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 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.

The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.

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:

• 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