A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Rate of childbirth by low way
研究概览
简要总结
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.
Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.
But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).
The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).
The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.
研究设计
- 研究类型
- Interventional
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
- •Pregnancy over 37 weeks
- •Singleton pregnancy
- •Vertex presentation
- •Previous caesarean section with unique Transversal segmentary incision
- •Medical indication of induction of labor
- •Unfavorable cervix with Bishop score < 4
- •No Premature Rupture Of Membranes
- •Informed consent
排除标准
- •Before 18 years old
- •Placenta Praevia
- •Premature Rupture Of Membranes
- •Uterine scar other than transversal segmentary incision
- •Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
- •Multiple pregnancy
- •Fetal malpresentation
- •Cesarean indication
- •Latex allergy
- •No informed consent
研究组 & 干预措施
oxytocin
干预措施: oxytocin (Drug)
balloon catheter
Dufour 1859H18
干预措施: balloon catheter (Procedure)
结局指标
主要结局
Rate of childbirth by low way
The childbirth by low way being considered as a success of the treatment
次要结局
- Rate of incidence of materno-fœtales morbidity