Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- vaginal delivery within 24 hours of hospital admission
研究概览
简要总结
The purpose of this study is to compare the effectiveness of sequential versus combined multimodal cervical ripening strategies to achieve vaginal delivery within 24 hours among nulliparous patients with singleton, vertex pregnancies at term undergoing induction of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous patients with singleton pregnancies with vertex lie at term receiving prenatal care that are eligible for outpatient cervical ripening will be eligible
排除标准
- •age less than 18,
- •suspected major fetal anomalies (including suspected or proven chromosome anomalies, congenital cardiac disease expected to require neonatal intervention, and multiple anomalies suggestive of a complex syndrome),
- •fetal growth restriction
- •oligohydramnios
- •prior full thickness
- •uterine scar
- •placenta previa,
- •low-lying placenta,
- •premature rupture of amniotic membranes,
- •cervical dilation > 2 cm
- •modified Bishop score > 4
- •residence greater than 60 minutes from the hospital
研究组 & 干预措施
Outpatient Sequential Cervical Ripening
Those assigned to sequential cervical ripening will be scheduled with a trained physician for placement of Dilapan-STM osmotic cervical dilators in the outpatient setting at 12 to 24 hours prior to their scheduled labor and delivery admission. Upon admission to labor and delivery, sequential patients will have Dilapan-S removed during clinical vaginal exam and will receive misoprostol 25 mcg every two hours up to 8 doses until modified Bishop score is greater than 4, warranting transition to oxytocin infusion.
干预措施: Sequential Cervical Ripening (Combination Product)
Inpatient Combined Cervical Ripening
Those randomized to scheduled induction of labor in the inpatient setting will present as scheduled to labor unit, at which time they will undergo clinical assessment and will receive placement of Dilapan-S by a trained physician along with misoprostol 25 mcg every 2 hours up to 8 doses or until clinical exam demonstrates modified Bishop score greater than 4, warranting transition to oxytocin infusion.
干预措施: Inpatient Combined Cervical Ripening (Combination Product)
结局指标
主要结局
vaginal delivery within 24 hours of hospital admission
时间窗: Admission to 24 hours
Number of Participants that complete vaginal delivery within 24 hours of hospital admission
时间窗: Admission to 24 hours
次要结局
未报告次要终点