An observational study in Pregnancy Related, Pregnancy Complications and Pregnancy, High Risk, sponsored by Sumitomo Pharma Switzerland GmbH. Recruiting at 1 site in United States. Open to female participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Sumitomo Pharma Switzerland GmbH · Observational
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.
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.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's planned enrollment of 728 is above the median of 320 across 205 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Sumitomo Pharma Switzerland GmbH is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include 2 cohorts of pregnant women: one cohort exposed to relugolix-containing therapy and one cohort of women with conditions for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix-containing therapy.
Cohort 1
Cohort 2
Exclusion Criteria:
The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy
Drug: Relugolix-Containing Product
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
Any relugolix-containing therapy
Also known as: TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Major Congenital Malformation (MCM)
Comparison of rate of MCM between cohorts
Time frame: Up to 10 years
Minor congenital malformations
Comparison of rate of minor congenital malformations between cohorts
Time frame: Up to 10 years
Spontaneous abortion (SAB)
Comparison of rate of SABs between cohorts
Time frame: Up to 10 years
Stillbirth
Comparison of rate of stillbirths between cohorts
Time frame: Up to 10 years
Elective termination
Comparison of rate of elective terminations between cohorts
Time frame: Up to 10 years
Preterm birth
Comparison of rate of preterm births between cohorts
Time frame: Up to 10 years
Small for gestational age (SGA)
Comparison of rate of SGA between cohorts
Time frame: Up to 10 years
Postnatal growth deficiency
Comparison of rate of postnatal growth deficiency between cohorts
Time frame: Up to 10 years
Infant developmental deficiency
Comparison of rate of infant developmental deficiency between cohorts
Time frame: Up to 10 years
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Sumitomo Pharma Switzerland GmbH