Pregnancy Complications, Pregnancy, High Risk, Pregnancy Related
Conditions
Keywords
Relugolix, Uterine Fibroids, Endometriosis, Pregnancy
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.
Interventions
DRUGRelugolix-Containing Product
Any relugolix-containing therapy
Sponsors
Sumitomo Pharma Switzerland GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
0 Years to No maximum
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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Congenital Malformation (MCM) | Up to 10 years | Comparison of rate of MCM between cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Elective termination | Up to 10 years | Comparison of rate of elective terminations between cohorts |
| Minor congenital malformations | Up to 10 years | Comparison of rate of minor congenital malformations between cohorts |
| Small for gestational age (SGA) | Up to 10 years | Comparison of rate of SGA between cohorts |
| Postnatal growth deficiency | Up to 10 years | Comparison of rate of postnatal growth deficiency between cohorts |
| Infant developmental deficiency | Up to 10 years | Comparison of rate of infant developmental deficiency between cohorts |
| Preterm birth | Up to 10 years | Comparison of rate of preterm births between cohorts |
Countries
United States
Contacts
Primary ContactClinical Trials at Myovant
Backup ContactMyovant Medical Monitor Study Director
Outcome results
None listed