Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- Time from initiation of cervical ripening to time of delivery measure in hours and minutes
研究概览
简要总结
Induction of labor (IOL) is a frequently performed procedure in obstetrics, aimed to achieve vaginal delivery when continuing the pregnancy is no longer advisable. A key determinant of IOL success is cervical ripening, particularly when the cervix is initially unfavorable. A range of preinduction methods is available, encompassing both mechanical and pharmacological approaches. Among mechanical techniques, the double balloon catheter (CRB) facilitates cervical dilation by applying direct pressure, which stimulates local prostaglandin release. In contrast, Dilapan-S, a synthetic osmotic dilator, works by gradually expanding through the absorption of cervical fluids, thereby applying gentle mechanical pressure.
While both methods are widely used and generally considered safe, there is limited evidence directly comparing their effectiveness and patient-centered outcomes. Mechanical methods are associated with a lower risk of uterine hyperstimulation compared to pharmacological alternatives. The choice between CRB and Dilapan-S may significantly influence labor duration, cesarean delivery rates, maternal comfort, and hospital resource utilization. This study aims to fill the existing knowledge gap by directly comparing Dilapan-S and CRB for term preinduction, with a focus on clinical efficacy and maternal satisfaction.
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
- 是
入选标准
- •• Singleton pregnancy
- •Cephalic fetal presentation
- •Gestational age ≥ 37+0 weeks
- •Indication for labor induction (e.g., postdates, maternal hypertension)
- •Bishop score ≤ 6
- •Maternal age ≥18 years
- •Ability to provide informed consent
排除标准
- •• Premature rupture of membranes (PROM)
- •Placenta previa, vasa previa, or abnormal placentation
- •Active genital tract infection
- •Prior classical cesarean section or extensive uterine surgery
- •Known fetal anomaly contraindicating vaginal delivery
- •Allergy or sensitivity to device materials
- •Any contraindication to labor induction or vaginal birth
结局指标
主要结局
Time from initiation of cervical ripening to time of delivery measure in hours and minutes
时间窗: from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes
次要结局
- Mode of delivery(at the time of delivery)
- Apgar Score(at the time of delivery)
- Need for additional ripening agent(From removal of CRB or dilapanS to 96 hours after enrollment)
- Maternal discomfort assessed by VAS(from CRB insertion or DilapanS removal (12 hours))
- NICU admission(From delivery to 28 days of life of the newborn)
- Chorioamnionitis(From enrollment to 6 weeks postpartum)
- Uterine Tachysystole(From enrollment to delivery (duration of labor measured in hours))
- Changes in fetal heart rate trace(From enrollment to delivery (labor measured in hours))
- Postpartum hemorrhage(From delivery to the first day (hours()
- Change in Bishop score after device removal(From the time of beggining of cervical ripening to the time of removal of the device (CRB or dilapan S) 12 hours)
研究者
Giuseppe Rizzo
Prof. Giuseppe Rizzo
University of Roma La Sapienza