EUCTR2017-001007-72-GB进行中（未招募）1 期
Atosiban versus placebo in the treatment of threatened preterm birth (APOSTEL 8). - APOSTEL 8
Amsterdam UMC, location AMC0 个研究点目标入组 1,514 人开始时间: 2019年2月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,514
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Women = 18 years old with a singleton or twin pregnancy with a gestational age between 30 0/7 and 33 6/7 weeks with threatened preterm birth defined by regular uterine contractions, and one of the following:
- •- Cervical length of < 15 mm or
- •- Cervical length of 15-30 mm and a positive fFn test (= 50 ng/mL) or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test - Ruptured amniotic membranes
- •- Cervical length of < 15 mm
- •- Cervical length of 15-30 mm and a positive fFn test or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1514
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Previous treatment for threatened preterm birth with corticosteroids in current pregnancy.
- •- Contra indication for tocolysis
- •- Signs of fetal distress
- •- Signs of intra uterine infection
- •- Fetal chromosomal or severe congenital abnormalities
研究者
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