Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Cesarian section rate
研究概览
简要总结
The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.
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
- 否
入选标准
- •Age 18 years of age or older.
- •Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
- •Having a Bishop score of 4 points or less.
- •Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
- •Willingness to comply with the protocol for the duration of the study.
- •Has agreed and signed an informed consent after given oral and written explanation.
排除标准
- •Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
- •Ruptured membranes.
- •Previous cesarian section or presence of any uterine scar.
- •Documented labor with four or more spontanous uterine contractions per hour.
- •Suspected fetal distress necessitating immediate intervention.
- •Proven malignancy of the cervix.
- •Active vaginal bleeding.
- •Active inflammatory or purulent condition of the lower genital tract.
- •Active asthma.
研究组 & 干预措施
Cook double balloon catheter
Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.
干预措施: Cook double balloon catheter (Device)
PGE1 tablet insertion
Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.
干预措施: PGE1 tablet (Drug)
结局指标
主要结局
Cesarian section rate
时间窗: 24 hours
次要结局
- Incidence of excessive uterine activity Incidence of excessive uterine activity(24 hours)
- Mode of delivery(24 hours)
- Active labor onset(24 hours)
- The ripening-to-delivery time interval(24 hours)
- Intra-partum or postpartum fever(48 hours)
- Incidence of meconium staining(24 hours)
- Proportion of vaginal delivery(24 hours)
- Treatment failure(12-24 hours)
- Need for oxytocin induction and/or augmentation of labor(24 hours)
- The proportion of neonates with 5-minute Apgar scores of less than 7(48 hours)
- The number of neonates who were admitted to the neonatal intensive care unit(48 hours)
- morbidity and mortality(48 hours)