NCT01360034Unknown3 期
Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
研究概览
简要总结
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between 24 and 34 weeks of gestation.
- •Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less
排除标准
- •All contraindications for tocolysis (fetal distress, abruptio placenta).
- •Multiple pregnancy.
- •All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
研究组 & 干预措施
Nifedipine
Experimental
108 patients will receive nifedipine as tocolytic for 48 hours.
干预措施: Nifedipine (Drug)
Indomethacin
Experimental
108 patients will receive indomethacin as tocolytic for 48 hours.
干预措施: Indomethacin (Drug)
结局指标
主要结局
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
时间窗: 36 months
次要结局
- Adverse effects(48 months)
- Reduction of preterm labour (before 35 weeks).(48 months)
研究者
Osvaldo A. Reyes T.
MD
Saint Thomas Hospital, Panama
研究点 (1)
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