Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 2
- 主要终点
- Proportion of women achieving vaginal delivery within 12 hours
研究概览
简要总结
The purpose of this study is to evaluate whether the use of cervical dilators for cervical ripening in case of second trimester medical termination of pregnancy (TOP) is effective to reduce duration of labor.
详细描述
Termination of pregnancy is a distressing and painful procedure for women. The use of cervical dilators could shorten the duration of labor but can generate more pain. The investigators will compare two procedures of induction of labor for second trimester termination of pregnancy: one with the use of oral prostaglandins (misoprostol) only and one with the exact same procedure preceded by cervical ripening with hygroscopic cervical dilators. Epidural analgesia will be effective previously to the placement of cervical dilators and the first tablet of misoprostol. Efficacy will be determined based on the proportion of women achieving vaginal delivery within 12 hours. The beginning of labor will be defined as the first administration of misoprostol tablets in both groups.
The investigators will also evaluate safety by collecting hemorrhage endometritis, cervical tear. The investigators will compare psychological impact of these procedures, measured by the impact of event scale and acceptability 1 to 4 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Termination of pregnancy requested by the patient and accepted by the weekly multidisciplinary counselling of fetal medicine
- •gestational age between 15 and 27 weeks and 6 days,
- •single pregnancy,
- •major patient,
- •French-speaking woman,
- •Patient with health insurance.
排除标准
- •Termination of pregnancy by surgical technique
- •cicatricial uterus
- •premature rupture of membranes
- •chorioamnionitis
- •multiple pregnancy
- •placenta praevia
- •myoma praevia
- •uterine malformation
- •unstable maternal pathology
- •psychiatric pathology
- •contraindication to mifepristone: severe asthma, adrenal insufficiency, porphyria, corticotherapy.
- •contraindication to misoprostol: hypersensitivity to prostaglandins.
- •contraindication to epidural analgesia: hemostasis disorder, spinal or medullary anomaly.
- •Bishop score > or = to 7 at arrival in birth room
结局指标
主要结局
Proportion of women achieving vaginal delivery within 12 hours
时间窗: 12 hours
The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.
次要结局
- Induction-to-amniotomy interval(12 hours)
- Induction-to-delivery interval(24 hours)
- Failure in induction of labor(24 hours)
- Pain assessment at the beginning of the procedure(Hour 0)
- Pain assessment of the whole procedure of TOP(48 hours)
- Distress assessment at discharge after TOP(4 months)
- Assessment of acceptability of the whole procedure of TOP(4 months)
- number of complications.(4 months)
- Duration of hospitalization.(48 hours)
- Cost of the procedure(4 months)
- Among nullipara, proportion of women achieving vaginal delivery within 12 hours(12 hours)