Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 384
- 试验地点
- 33
- 主要终点
- The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
研究概览
简要总结
The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.
详细描述
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
- •Singleton pregnancy
- •Intact membranes
- •Preterm labor defined as:
- •2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
- •short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
- •cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
- •cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
- •positive fetal fibronectin
- •Age ≥ 18 years old
- •Signed informed consent
- •Possible and accepted follow-up
排除标准
- •Multiple gestation
- •Cervical cerclage
- •Hydramnios (AFI >95th percentile for gestational age or greatest pocket >8 cm)
- •Premature rupture of membranes
- •Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
- •Cervical dilatation > 3 cm
- •Placenta praevia or abruptio placentae
- •Intra-uterine growth restriction or non-reassuring fetal status
- •Pre-eclampsia or severe hypertension
- •Any other maternal or fetal pathology which should indicate medically preterm delivery
研究组 & 干预措施
1
干预措施: progesterone (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
时间窗: end of pregnancy
次要结局
- Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects(end of pregnancy and 28 days after delivery)
研究者
begoña Martinez de Tejada
MD, PhD
University Hospital, Geneva