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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk

Intervention / Treatment
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* Drug: Relugolix-Containing Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed Cohort<br>Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy | Drug: Relugolix-Containing Product<br>* Any relugolix-containing therapy<br>* Other names: MYFEMBREE;|
| Unexposed Cohort<br>Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing therapy at any time during pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Congenital Malformation (MCM) | Comparison of rate of MCM between cohorts | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor congenital malformations | Comparison of rate of minor congenital malformations between cohorts | Up to 10 years | 
| Spontaneous abortion (SAB) | Comparison of rate of SABs between cohorts | Up to 10 years | 
| Stillbirth | Comparison of rate of stillbirths between cohorts | Up to 10 years | 
| Elective termination | Comparison of rate of elective terminations between cohorts | Up to 10 years | 
| Preterm birth | Comparison of rate of preterm births between cohorts | Up to 10 years | 
| Small for gestational age (SGA) | Comparison of rate of SGA between cohorts | Up to 10 years | 
| Postnatal growth deficiency | Comparison of rate of postnatal growth deficiency between cohorts | Up to 10 years | 
| Infant developmental deficiency | Comparison of rate of infant developmental deficiency between cohorts | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relugolix, Uterine Fibroids, Endometriosis, Pregnancy