Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Number of Participants with Bishop score ≥6 or spontaneous labour
研究概览
简要总结
A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.
详细描述
Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day.
The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.
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
- 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
- 是
入选标准
- •Pregnant woman scheduled for induction of labor.
- •Age between 18 and 45 years.
- •Understanding and capable to sign informed consent.
- •Singleton pregnancy.
- •Gestational age ≥ 37 0/7 weeks.
- •Live fetus in cephalic presentation.
- •Intact membranes
- •Bishop score < 6
- •Estimated fetal weight < 4500g
- •Without contraindication to vaginal delivery
- •No major fetal anomaly
排除标准
- •Previous cesarean section or myomectomy
- •Hypertension
- •Thyroid disease
- •Maternal conditions with high risk of placental insufficiency
结局指标
主要结局
Number of Participants with Bishop score ≥6 or spontaneous labour
时间窗: 24 hours
Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention
次要结局
- Cesarean deliveries(1-4days)
- Mean of gain in Bishop score(24 hours)
- Operative deliveries(1-4days)
- Reduced fetal movements(24 hours)
- Non reassuring fetal status(24 hours)
- Patient Satisfaction: questionnaire(1-4days)
- Time of Vaginal Delivery(2-4days)
- Analgesia requirement(24 hours)
- Time frame between intervention and active phase of labour(1-2 days)
- Number of Participants with vaginal delivery within 24hrs(1-2days)
- Vaginal delivery within 48hrs(1-2days)
- Pharmacological agents for labor induction (Prostaglandins, Oxytocin)(1-2days)
- Vaginal bleeding(24 hours)
研究者
Maria de Carvalho Afonso
Medical Doctor, Phd Student
Centro Hospitalar Lisboa Norte