Prevention of Recurrent Preterm Birth With Micronized Progesterone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of Recurrent Preterm Birth
研究概览
简要总结
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
详细描述
To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation.
排除标准
- •multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.
研究组 & 干预措施
Progesterone Group
Oral Micronized Progesterone
干预措施: oral micronized progesterone (Drug)
Placebo
Identical Placebo Tablet
干预措施: Identical Placebo tablet (Drug)
结局指标
主要结局
Rate of Recurrent Preterm Birth
时间窗: Prior to 37 weeks' gestation
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
次要结局
- Secondary Outcomes(Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group)
研究者
David S. McKenna
PI
Fetal Medicine Foundation