Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Time(hours) from initiation of induction of labour to vaginal delivery
研究概览
简要总结
The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Obese (BMI >30 before 20 weeks gestational age)
- •Singleton pregnancy
- •Vertex presentation
- •Bishop Score <6
- •Intact membranes
- •Gestational age 37+0 to 42+0
- •Normal fetal heart tracing on admission for ripening
排除标准
- •Induction of labour for intrauterine fetal demise
- •Intrauterine growth restriction
- •Suspected abruption at the start of induction
- •Any contraindication for a vaginal delivery
研究组 & 干预措施
dinoprostone
Group of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours
干预措施: Dinoprostone (Drug)
Single balloon foley catheter
Group of women that will have a single balloon foley catheter inserted for induction of labour
干预措施: Single balloon foley catheter (Device)
结局指标
主要结局
Time(hours) from initiation of induction of labour to vaginal delivery
时间窗: Will be assessed at the end of each vaginal delivery
次要结局
- Number of chorioamnionitis cases in each group(2 years)
- Number of vaginal deliveries within 24 hours in each group(2 years)
- Number of cesarean sections in each group(2 years)
- Number of operative vaginal deliveries in each group(2 years)
- Number of babies that required neonatal intensive care unit (NICU) admission in each group(2 years)
- Number of patients that required oxytocin administration in each group(2 years)
- Number of patients that required an epidural in each group(2 years)
- Number of babies that had an arterial pH <7 in each group(2 years)
- Number of babies that had an APGAR score <7 at 5 minutes(2 years)
研究者
Dr. Christine Lett
Clinical Assistant Professor of Obstetrics & Gynecology, University of Saskatchewan
Saskatchewan Health Authority - Regina Area