NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,409
- 试验地点
- 1
- 主要终点
- Number of cesarean sections
研究概览
简要总结
The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.
详细描述
The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score<6 will be induced with prostaglandins according to local protocols.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IMN
Isosorbide mononitrate
干预措施: IMN (Drug)
Placebo
Administration of placebo of IMN
干预措施: Placebo (Drug)
结局指标
主要结局
Number of cesarean sections
时间窗: 10 days
次要结局
- Number of labor inductions(10 days)
- Number of spontaneous labors(10 days)
- Cesarean for failed labor induction(10 days)
- Cesarean for FHR abnormalities(10 days)
- Cesarean for arrested labor(10 days)
- Mean time between randomisation and spontaneous labor(10 days)
- Isosorbide mononitrate adverse effects(10 days)
- Maternal satisfaction(10 days)
- Neonatal morbidity(10 days)
- Mean time between randomisation and delivery(10 days)
- Mean duration of labor(10 days)