Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 728
- 试验地点
- 1
- 主要终点
- Major Congenital Malformation (MCM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman of any age
- •Currently or recently pregnant
- •Consent to participate
- •Authorization for her HCP(s) to provide data to the registry
- •Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
- •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
排除标准
- •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
研究组 & 干预措施
Exposed Cohort
Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy
干预措施: Relugolix-Containing Product (Drug)
结局指标
主要结局
Major Congenital Malformation (MCM)
时间窗: Up to 10 years
Comparison of rate of MCM between cohorts
次要结局
- Minor congenital malformations(Up to 10 years)
- Spontaneous abortion (SAB)(Up to 10 years)
- Stillbirth(Up to 10 years)
- Preterm birth(Up to 10 years)
- Elective termination(Up to 10 years)
- Small for gestational age (SGA)(Up to 10 years)
- Infant developmental deficiency(Up to 10 years)
- Postnatal growth deficiency(Up to 10 years)