MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Major Congenital Malformation (MCM)
研究概览
简要总结
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.
详细描述
The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman ≥ 18 and ≤ 50 years of age at time of conception
- •Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception)
- •Exposure to relugolix combination therapy at any time during pregnancy
- •No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)
排除标准
- •Exposure to known teratogens during pregnancy
- •< 6 months of continuous healthcare coverage immediately prior to date of conception
研究组 & 干预措施
Exposed Cohort
Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy
干预措施: Relugolix + Estradiol + Norethindrone Acetate (Drug)
结局指标
主要结局
Major Congenital Malformation (MCM)
时间窗: Up to 5 years
Comparison of rate of MCM between cohorts
次要结局
- Spontaneous abortion (SAB)(Up to 5 years)
- Small for gestational age (SGA)(Up to 5 years)
- Stillbirth(Up to 5 years)
- Preterm birth(Up to 5 years)