Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- time to delivery (hours) defined
研究概览
简要总结
Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.
Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.
详细描述
This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.
This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.
Women will be randomized with equal probability to the intervention group using block randomization stratified by party.
Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •full term (≥37 weeks) gestations determined by routine obstetrical guidelines
- •singleton gestation in cephalic presentation
- •Both nulliparous and multiparous women
- •Intact membranes
- •Cervical dilation ≤2cm
排除标准
- •Any contraindication to a vaginal delivery or to misoprostol
- •fetal demise
- •Multifetal gestation
- •prior uterine surgery, previous cesarean section
- •Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
- •women with HIV, and women with medical conditions requiring an assisted second stage
- •Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies
- •As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)
研究组 & 干预措施
Vaginal Misoprostol in combination with foley bulb
Women in the vaginal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of misoprostol per vagina along with the insertion of a16F Foley catheter with a stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
Vaginal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
干预措施: Misoprostol (Drug)
Buccal Misoprostol in combination with foley bulb
misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
干预措施: Misoprostol (Drug)
结局指标
主要结局
time to delivery (hours) defined
时间窗: through study completion, an average of 2 year
as time from initiation of induction method to delivery time, regardless of mode of delivery.
次要结局
- Rate of 3rd/4th degree perineal laceration(through study completion, an average of 2 year)
- Rate of Cesarean delivery(through study completion, an average of 2 year)
- Indication for cesarean delivery(through study completion, an average of 2 year)
- Rate of Maternal Blood transfusion(through study completion, an average of 2 year)
- Rate of Maternal Death(through study completion, an average of 2 year)
- Rate of Chorioamnionitis(through study completion, an average of 2 year)
- Rate of terbutaline use(through study completion, an average of 2 year)
- Rate of Intrauterine pressure catheter use(through study completion, an average of 2 year)
- Rate of head cooling.(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of Intensive care unit admission(through study completion, an average of 2 year)
- Rate of Analgesia use(through study completion, an average of 2 year)
- Rate of Intraventricular hemorrhage grade 3 or 4(From time of delivery to hospital discharge; up to 6 weeks)
- Time to active labor(through study completion, an average of 2 year)
- Maternal length of stay(through study completion, an average of 2 year)
- Rate of Venous thromboembolism(through study completion, an average of 2 year)
- Rate of Hysterectomy(through study completion, an average of 2 year)
- Rate of Hypoxic ischemic encephalopathy(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of Wound separation-infection(From time of delivery to time of hospital discharge; up to 6 weeks)
- Rate of Severe respiratory distress syndrome(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of Neonatal blood transfusion(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of Endometritis(through study completion, an average of 2 year)
- Rate of Amnioinfusion(through study completion, an average of 2 year)
- Rate of Culture proven-presumed neonatal sepsis(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of NICU admission(From time of delivery to hospital discharge; up to 6 weeks)
- Rate of Necrotizing enterocolitis(From time of delivery to hospital discharge; up to 6 weeks)
研究者
Helen Beatriz Gomez
Resident Physician
Christiana Care Health Services