Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- vaginal delivery rate
研究概览
简要总结
The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.
详细描述
This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error.
The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).
The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score >6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.
The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40
- •Singleton pregnancy
- •Vertex presentation
- •Bishop score <6
- •Using a Foley catheter or cook balloon for cervical ripening
- •High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders)
排除标准
- •Being younger than 18 or over 40
- •Communication problems (foreign national)
- •Bishop score >6
- •Being at active labor
- •Multifetal pregnancy
- •Non-vertex presentation
- •Scarred uterus (cesarean or myomectomy)
- •Fetal structural or chromosomal anomaly
- •Non-reassuring fetal cardiotocography before cervical ripening
- •Regional anesthesia during the first stage
结局指标
主要结局
vaginal delivery rate
时间窗: until the patient gives birth
the difference in vaginal birth rate between groups
vaginal delivery within 24 hours
时间窗: from the time of cervical ripening catheter insertion to the 24 hours
the difference in vaginal delivery within 24 hours rate between groups
bishop score
时间窗: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
bishop score \>6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)
次要结局
未报告次要终点
研究者
Kemal Sarsmaz
Principal Investigator
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital