Clinical trial NCT05739123: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Official title: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Pregnancy Complications
Pregnancy, High Risk
Keywords: Relugolix
Uterine Fibroids
Endometriosis
Pregnancy
Lead sponsor: Sumitomo Pharma Switzerland GmbH
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 728
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Congenital Malformation (MCM)
timeFrame: Up to 10 years
Secondary outcomes:
measure: Minor congenital malformations
timeFrame: Up to 10 years
measure: Spontaneous abortion (SAB)
timeFrame: Up to 10 years
measure: Stillbirth
timeFrame: Up to 10 years
measure: Elective termination
timeFrame: Up to 10 years
measure: Preterm birth
timeFrame: Up to 10 years
measure: Small for gestational age (SGA)
timeFrame: Up to 10 years
measure: Postnatal growth deficiency
timeFrame: Up to 10 years
measure: Infant developmental deficiency
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
References: