NCT02262481已完成不适用
A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The recurrence of uterine contraction within 48 hours after stop tocolytic
研究概览
简要总结
The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.
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
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Preterm labor
- •GA24-34wk
- •Intact membranes
排除标准
- •Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
- •Placenta previa
- •medical and obstetric complications
- •allergy to dydrogesterone
研究组 & 干预措施
Dydrogesterone
Active Comparator
tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
干预措施: dydrogesterone (Drug)
Placebo
Placebo Comparator
tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
干预措施: placebo (Drug)
结局指标
主要结局
The recurrence of uterine contraction within 48 hours after stop tocolytic
时间窗: 48 hours
次要结局
- side effects(9 weeks)
- Number of newborn with intraventricular hemorrhage(9 weeks)
- Time from preterm labor pain to delivery(9 weeks)
- Number of newborn with respiratory distress syndrome(9 weeks)
- Number of newborn with necrotizing enterocolitis(9 weeks)
- Number of newborn with sepsis(9 weeks)
- Gestational age at delivery(9 weeks)
研究者
Vorapong Phupong
Vorapong
Chulalongkorn University
研究点 (1)
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