Progesterone Supplementation for the Prevention of Preeclampsia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Development of preeclampsia
研究概览
简要总结
This randomized controlled trial evaluates whether nightly vaginal micronized progesterone (400 mg) initiated before 12 weeks' gestation reduces the incidence of preeclampsia in low-risk pregnant individuals. Participants will be randomly assigned (1:1) to receive either vaginal progesterone through 16 weeks' gestation or routine prenatal care without progesterone. Maternal and neonatal outcomes-including development of preeclampsia, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant individuals receiving prenatal care at participating clinics
- •<12 weeks gestation with a viable intrauterine pregnancy
- •Age ≥18 years
- •English-speaking
排除标准
- •Unable or unwilling to self-administer vaginal progesterone
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Control
Progesterone
干预措施: Progesterone supplementation (Drug)
结局指标
主要结局
Development of preeclampsia
时间窗: Antenatally and up to 6 weeks postpartum
Defined as new onset systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 on two occasions at least 4 hours apart, after 20 weeks gestation, with proteinuria or evidence of maternal acute kidney impairment, liver dysfunction, neurologic features, hemolysis, or thrombocytopenia
次要结局
未报告次要终点
研究者
Brittany Austin
Assistant Professor-Faculty
Medical University of South Carolina