Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Induction to delivery time
研究概览
简要总结
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vaginal misoprostol alone
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols
干预措施: Misoprostol (Drug)
Vaginal misoprostol + Foley catheter
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.
干预措施: Misoprostol (Drug)
Vaginal misoprostol + Foley catheter
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.
干预措施: Foley catheter (Device)
结局指标
主要结局
Induction to delivery time
时间窗: 1 year
次要结局
- Percentage of pregnant women requiring oxytocin(1 year)
- Percentage of pregnant women requiring epidural analgesia(1 year)
- Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations(1 year)
- Percentage of pregnant women with intrapartum fever(1 year)
- Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction(through study completion)
- Apgar score at 5 minutes(1 year)
- Number of doses of misoprostol required(1 year)
- Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction(1 year)
- Umbilical artery ph(1 year)
- Bishop score at 24 hours from the onset of induction(1 year)
- Neonatal intensive care unit admission(1 year)
- Bishop score at 12 hours from the onset of induction(1 year)
- Maximum dosage of oxytocin given (mU / min)(1 year)
- Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations(1 year)
- Total rate of cesarean section(1 year)
- Percentage of cesarean sections for failed induction(1 year)
- Percentage of pregnant women with maternal side effects(1 year)
- Percentage of cesarean sections for nonreassuring fetal status(1 year)
研究者
Dra Angels Vives Argilagós
Obstetrician
Consorci Sanitari de Terrassa