Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- induction to delivery interval
研究概览
简要总结
The objective of this study is to provide a comprehensive analysis of various time intervals (1:1). In addition to evaluating the time interval until delivery after completion of induction, the study also aims to investigate the rate of vaginal births and the type of combination therapy used (including the method of implementation and subsequent induction).
详细描述
Approximately 22% of births in Germany are induced annually using either medicinal, mechanical, or sequential mechanical/medicinal methods, with oxytocin and prostaglandins being the available drug options. Double balloon catheters have been used in clinics for over a decade for mechanical induction of labour, resulting in cervical ripening and possible onset of labour through endogenous prostaglandin release. This method is associated with low rates of uterine tachysystole and maternal and neonatal morbidity.
The recommended placement time for the double balloon catheter is 12 hours, typically performed at night in an inpatient setting, which may cause early exhaustion and fatigue for patients. However, a study has shown that a shorter insertion time of 6 hours is equally safe and effective, without any time savings beyond the shortened insertion time.
This study aims to investigate the feasibility and effectiveness of shortening the induction birth interval from 12 to 6 hours. The investigators hypothesize that this will result in a shorter induction birth interval with comparable maternal and neonatal outcomes. This analysis will test the effectiveness of the shortened induction birth interval.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •destational age above or equal 37/0 weeks of gestation
- •desired spontanous delivery
- •Bishop-Score below or equal to 5
- •cranial position
- •single pregnancy
排除标准
- •unable to consent
- •pathological CTG according FIGO criteria
结局指标
主要结局
induction to delivery interval
时间窗: From date and time of beginning of labour induction to date and time of birth, assessed as long as needed, but not longer than 5 days
the induction to delivery interval measured in minutes
次要结局
- blood loss during delivery(at time of delivery)
- number of participants with meconium-containing amniotic fluid(at time of delivery)
- mode of delivery(after induction of labour at time of delivery)
- number of participants with sequential drug induction of labour(assessd after double balloon catheter placement until time of birth, but not longer than 3 days)
- arterial umbilical pH(at time of delivery)
- number of participants with uterine rupture(at time of delivery)
- prostaglandin to delivery interval(From date and time of beginning of prostaglandin treatment to date and time of birth, assessed as long as needed, but not longer than 3 days)
- arterial umbilical base excess(at time of delivery)
- number of participants neonatal acidosis(at time of delivery)
- number of participants with pathological cardiotocography (CTG)(at time of labour induction)
- apgar 5 min(5 minutes after delivery)