NCT02196103Unknown2 期
Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 主要终点
- vaginal delivery rate
研究概览
简要总结
Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed to be pregnant with PROM at >34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
- •Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
- •Found to have an unripe cervix in a speculum examination.
- •Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
- •Previous on cesarian section.
- •Willingness to comply with the protocol for the duration of the study.
- •Have signed an informed consent.
排除标准
- •Patients having any of the following conditions:
- •Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
- •Regular uterine contractions (3-5/10 min).
- •Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.
- •Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC>/=20,000)
- •Suspected placental abruption or presence of a significant hemorrhage.
- •Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
结局指标
主要结局
vaginal delivery rate
时间窗: 48 hours
20% higher vaginal delivery rate
次要结局
- safety(48 hours)
研究者
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