Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
- Conditions
- Pregnancy, High RiskPregnancy ComplicationsPregnancy Related
- Interventions
- Drug: Relugolix-Containing Product
- Registration Number
- NCT05739123
- Lead Sponsor
- Sumitomo Pharma Switzerland GmbH
- Brief 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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 728
- 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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed Cohort Relugolix-Containing Product Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy
- Primary Outcome Measures
Name Time Method Major Congenital Malformation (MCM) Up to 10 years Comparison of rate of MCM between cohorts
- Secondary Outcome Measures
Name Time Method Minor congenital malformations Up to 10 years Comparison of rate of minor congenital malformations between cohorts
Elective termination Up to 10 years Comparison of rate of elective terminations between cohorts
Spontaneous abortion (SAB) Up to 10 years Comparison of rate of SABs between cohorts
Stillbirth Up to 10 years Comparison of rate of stillbirths between cohorts
Preterm birth Up to 10 years Comparison of rate of preterm births between cohorts
Postnatal growth deficiency Up to 10 years Comparison of rate of postnatal growth deficiency between cohorts
Small for gestational age (SGA) Up to 10 years Comparison of rate of SGA between cohorts
Infant developmental deficiency Up to 10 years Comparison of rate of infant developmental deficiency between cohorts
Trial Locations
- Locations (1)
PPD
🇺🇸Wilmington, North Carolina, United States