A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Mode of delivery
研究概览
简要总结
Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
详细描述
The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. All subjects participating in the study will be induced for obstetrical indications alone.
The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
The participants will finish participation in the study after delivery.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any pregnant woman at term with an obstetric indication for labor induction.
排除标准
- •Previous cesarean section.
- •Positive Oxytocin challenge test.
- •Positive contraction stress test.
研究组 & 干预措施
BMI>30+Dinoprostone
Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
干预措施: Dinoprostone (Drug)
BMI<30+Dinoprostone
Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
干预措施: Dinoprostone (Drug)
BMI>30+Cervical ripening balloon
Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
干预措施: Double lumen cervical ripening balloon. (Device)
BMI<30+Cervical ripening balloon
Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
干预措施: Double lumen cervical ripening balloon. (Device)
结局指标
主要结局
Mode of delivery
时间窗: Up to 5 days.
Vaginal delivery in oppose to cesarean section.
次要结局
- Neonatal complications and outcome.(Up to 5 days.)
- Induction success.(Up to 5 days.)
- Time to delivery(Up to 5 days.)
研究者
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus