Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Time from hospital admission to delivery of the newborn
研究概览
简要总结
The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are:
- Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol
- Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol
Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.
详细描述
This is a prospective randomized unblinded control trial. Consented patients will have a cervical exam performed in the clinic to confirm that the bishop score is less than 6. Once this and the inclusion criteria are met, the participant will be randomized to either the outpatient transcervical foley arm or the vaginal misoprostol arm. Each pregnant woman will undergo the intervention stated in the numbered envelope which will be distributed based on their order of inclusion in the study. Due to the nature of the procedure, blinding could not be done.
Participants randomized to the transcervical foley group will be scheduled an appointment in the clinic the day before their scheduled induction day for the final screen and foley placement. On the other hand, participants randomized to the vaginal misoprostol group will be admitted to the labor and delivery unit on the day of their scheduled induction. All participants will undergo a cervical examination before the assigned intervention to verify their eligibility status. Those who do not meet the eligibility criteria, will be excluded. Both transcervical foley and vaginal misoprostol are standard of care for induction of labor at Hurley Medical Center. Thus, there would be no additional cost to the patient. The only difference in the study is the setting in which the transcervical foley is placed, i.e. in the obstetrics clinic as an outpatient.
Oxytocin will be initiated in all patients who did not have at least three regular contractions in 10 minutes. Continuous fetal heart rate monitoring and uterine activity monitoring will be performed in all patients. Amniotomy will be performed during the course of labor at the discretion of the health care provider and epidural anesthesia will be administered per the patient's request.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term singleton pregnancy (37 weeks of gestation or greater)
- •Bishop score less than 6 and a maximum cervical dilation of 2 cm
- •Cephalic presentation
排除标准
- •Rupture of membranes
- •Regular uterine contractions (3 or more contractions per 10 minutes)
- •History of prior uterine surgery (cesarean delivery or myomectomy)
- •Multiples gestations
- •Malpresentation
- •Nonreassuring fetal heart tracing (category 3 or persistent category 2)
- •Fetal demise
- •Anomalous fetus
- •Any contraindication to vaginal delivery
结局指标
主要结局
Time from hospital admission to delivery of the newborn
时间窗: From hospital admission until delivery of the newborn
The primary outcome is to determine if there is a difference in the time from admission to delivery for those who receive transcervical foley balloon in the clinic the day before induction compared to those who get vaginal misoprostol in the hospital on the day of the induction
次要结局
- Chorioamnionitis/endometritis(From hospital admission until 2 weeks postpartum)
- Cesarean delivery(From hospital admission until delivery of the newborn)
- Postpartum hemorrhage(From hospital admission until 2 weeks postpartum)
- Delivery within 24 hours of hospital admission(From hospital admission until delivery of the newborn)
- Total hospital length of stay(From hospital admission until discharge, assessed up to a week)
- Hospital readmission within 30 days of discharge(From discharge until 30 days postpartum)
- Cervical examination at the time of admission(Within the first hour of hospital admission)
- Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission(From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours)
- Frequency of acetaminophen use after randomization but before hospital admission(From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours)
- Spontaneous rupture of membranes between randomization and hospital admission(From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours)
- Duration of oxytocin infusion (in min)(From hospital admission until delivery of the newborn)
- Maximum oxytocin rate infused (in milliunits/min)(From hospital admission until delivery of the newborn)
- Duration of neuraxial anesthesia use(From hospital admission until delivery of the newborn)
- Presence of heavy vaginal bleeding before delivery(From outpatient transcervical foley balloon insertion until delivery of newborn)
- Meconium-stained amniotic fluid(From hospital admission until delivery of the newborn)
- Time from rupture of membranes to delivery(From time of rupture of membranes until delivery of the newborn)
- Highest maternal intrapartum temperature(From hospital admission until delivery of the newborn)
- Admission white blood cell count(From hospital admission until delivery of the newborn)
研究者
Atinuke Akinpeloye
Core faculty in the department of Obstetrics and Gynecology
Hurley Medical Center