The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Number of Participants With a Need for Cesarean Delivery
研究概览
简要总结
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
详细描述
Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.
In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combined approach: Foley Balloon + Vaginal Misoprostol
These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
干预措施: Foley Balloon + Vaginal Misoprostol (Device)
Single approach: Vaginal Misoprostol only
These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.
干预措施: Vaginal Misoprostol (Drug)
结局指标
主要结局
Number of Participants With a Need for Cesarean Delivery
时间窗: Induction to delivery
次要结局
- Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities(Induction to delivery)
- Number of Participants With Clinical Chorioamnionitis(Induction to delivery)
- Number of Participants With a Need for Oxytocin Augmentation(Induction to delivery)
- Number of Participants With a Need for Operative Vaginal Delivery(Induction to delivery)
- Indication for Cesarean Delivery(Induction to delivery)
- Induction-to-delivery Interval in Hours(Induction to delivery)
- Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity(Induction to discharge (approximately 5 days))
- Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)(From delivery to neonatal discharge (approximately 2 to 7 days))
- Number of Newborns With Transient Tachypnea (TTN)(From delivery to neonatal discharge (approximately 2 to 7 days))
- Number of Newborns With Respiratory Distress Syndrome (RDS)(From delivery to neonatal discharge (approximately 2 to 7 days))
- Number of Newborns With Meconium Aspiration Syndrome(From delivery to neonatal discharge (approximately 2 to 7 days))
- Number of Newborns With Culture-proven Sepsis(From delivery to neonatal discharge (approximately 2 to 7 days))
- Number of Newborns With Seizures(From delivery to neonatal discharge (approximately 2 to 7 days))
- Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity(From delivery to neonatal discharge (approximately 2 to 7 days))
研究者
Mesk A.Jawad Alrais
Clinical Resident
The University of Texas Health Science Center, Houston