Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
试验速览
- 阶段
- 4 期
- 入组人数
- 213
- 主要终点
- Preterm delivery <34 weeks
研究概览
简要总结
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Monochorionic or Dichorionic twin pregnancies
- •18 weeks to 24 weeks at inclusion.
排除标准
- •Cerclage before inclusion
- •Contractions, rupture of the membranes, cervix dilation,
- •Short cervix (15mm or 20mm if there is history of preterm delivery
- •Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
- •Younger than 14 years.
研究组 & 干预措施
Progesterone
Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.
干预措施: Progesterone (Drug)
Placebo
Placebo Gel, for daily use from 18 weeks to 34 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Preterm delivery <34 weeks
时间窗: 14 months
Spontaneous labor under 34 weeks.
次要结局
- Preterm delivery <37 weeks(14 months)
研究者
Masami Yamamoto
MD
Clinica Alemana de Santiago