Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- induction-to-birth interval reduction
研究概览
简要总结
This study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. The study evaluates whether this reduction can be achieved without increasing cesarean section rates or maternal-fetal risks
详细描述
Scientific Justification: Labor induction affects 25% of pregnancies in France, with 70% requiring cervical ripening. While the 12-hour pose is standard, recent evidence suggests that shorter durations (6h) are effective but remain difficult to integrate into hospital workflows. Since the mechanical and physiological effects of the balloon are early phenomena, a 3-hour protocol could optimize bed management and patient comfort.
Strategy: Comparison between an experimental group (3-hour balloon pose followed by immediate active labor management regardless of Bishop score) and a control group (standard 12-hour balloon pose).
Follow-up: Participants are followed from the day of induction until hospital discharge (generally 2 to 10 days) to assess obstetric outcomes, neonatal safety, and maternal satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •singleton pregnancy
- •≥ 34 weeks of gestation,
- •cephalic presentation,
- •Bishop score < 6,
- •healthy uterus,
- •standard indication for labor induction
排除标准
- •Minor patients,
- •ruptured membranes,
- •twin pregnancy,
- •fetal malpresentation,
- •placenta previa,
- •previous uterine scar,
- •known fetal malformation
结局指标
主要结局
induction-to-birth interval reduction
时间窗: balloon insertion and birth of the child
Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child
次要结局
未报告次要终点