Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of Cesarean Delivery
研究概览
简要总结
The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise
详细描述
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation.
In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
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
- •• Age > 18 years old
- •Singleton, or twins with demise of one
- •Cephalic presentation
- •Intact membranes
- •Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP)
- •Oligohydramnios (AFI< 5cm and/or MVP <2cm)
- •Fetal growth restriction (EFW or AC <10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers
- •Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal movement) prompting induction of labor
- •Suspected placental abruption
- •Poorly controlled pre-gestational diabetes, defined as >50% abnormal glucose values requiring increasing doses of anti-glycemic agents >34 weeks, or requiring delivery
- •Gestational Age > 22 weeks
- •Bishop score < 6
排除标准
- •• Prior cesarean delivery
- •Allergy to misoprostol
- •Allergy to oxytocin
- •Allergy to silicone/latex
- •Contraindication to vaginal delivery including placenta or vasa previa, Placenta accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load >1000 copies/mL
研究组 & 干预措施
Oxytocin with Mechanical Dilation
If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement.
If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation.
干预措施: Oxytocin (Drug)
Misoprostol with Mechanical Dilation
If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of Cesarean Delivery
时间窗: 48 hours
Total rate of cesarean delivery
次要结局
- The time interval from induction-to-delivey for vaginal deliveries(48 hours)
- The rate of stillbirth(48 hours)
- The number of vaginal births within 24 hours(24 hours)
- The number of misoprostol doses received by each participant(24 hours)
- The incidence of uterine tachysystole(24 hours)
- The rate of each indication for the cesarean delivery(48 hours)
- The rate of operative vaginal delivery(48 hours)
- The rate of intra-amniotic infection(48 hours)
- The rate of postpartum hemorrhage(24 hours)
- The rate of Fetal heart rate abnormaliies(48 hours)
- The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection(24 hours)
- The total rate of Neonatal Apgar scores less than 7 at 5 minutes(5 minutes)
- The total rate of Neonatal RDS(96 hours)
- The total rate of Neonatal admission to the NICU(96 hours)
- The total rate of neonatal arterial umbilical blood pH < 7.1(96 hours)
- The rate of neonatal Sepsis(96 hours)
- The rate of Neonatal Death(96 hours)
研究者
Leen Al-Hafez
Principal Investigator
Thomas Jefferson University