Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Interval from induction to delivery
研究概览
简要总结
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be computer generated. Allocation concealment will be ensured by opaque sealed envelopes. Blinding of outcomes assessor, principal as well as other investigators will be ensured as randomization will be performed by an external investigator that will not participate in the clinical process of the study or the statistical analysis. The ward midwife will open the randomization envelope after patient enrollment and different types of vaginal washing will be applied as per randomization. Participant as well outcomes assessor (physician that will evaluate the progress of labor as well statistician involved in the analysis) will be blinded to the procedure.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Full term (>37 weeks)
- •Cephalic presentation
- •Reactive NST (nonstress test)
- •Absence of spontaneous uterine contractions
- •No contraindications to vaginal delivery
排除标准
- •Multifetal pregnancy
- •Fetal malpresentation
- •Preterm delivery (<37 weeks)
- •Advanced maternal age (>40 years)
- •Bishop score > 7
- •Fetal macrosomia ( >4500 gr)
- •Non reassuring NST (nonstress test)
- •Suspected chorioamnionitis
- •Previous cesarean delivery or other uterine surgery
研究组 & 干预措施
Vaginal washing 5% acetic acid
干预措施: Vaginal washing with 5% acetic acid (Other)
Vaginal washing 0.9% N/S
干预措施: Vaginal washing with 0.9% NS (Other)
结局指标
主要结局
Interval from induction to delivery
时间窗: 36 hours
Time interval (minutes)
次要结局
- Interval from induction to active labor(36 hours)
- Interval from induction to second stage of labor(36 hours)
- Failure of induction of labor(36 hours)
研究者
Georgios Daskalakis
Professor of Obstetrics and Gynecology
Alexandra Hospital, Athens, Greece