A Cluster Randomized Trial of Labor Induction With Oral Versus Vaginal Misoprostol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,546
- 试验地点
- 1
- 主要终点
- Number of Participants with Vaginal Delivery
研究概览
简要总结
This study will compare vaginal and oral misoprostol, to determine whether a vaginal misoprostol regimen achieves a higher vaginal delivery rate in a real-world, high-volume setting, and whether this regimen reduces time and oxytocin need on a high-volume Labor and Delivery unit at Parkland Hospital.
Our primary hypothesis is that among women with singleton, term pregnancies, cervical dilation 2cm or less, and indicated labor induction, the rate of vaginal delivery is significantly increased when a standardized vaginal misoprostol regimen is used, compared with a standardized oral misoprostol regimen.
详细描述
The purpose of this study is to determine whether the use of a standardized vaginal misoprostol regimen will result in a decreased primary cesarean delivery rate among women with a cervical dilation of 2 centimeters of less who require induction of labor at term, compared with the currently used oral misoprostol regimen. We also aim to evaluate oxytocin use, time to delivery, uterine activity, indication for cesarean delivery, intrapartum and postpartum infectious morbidities, excess blood loss at delivery, and adverse neonatal outcomes in the overall population as well as nulliparous women specifically.
This will be a prospective, cluster-randomized clinical trial to compare the rate of vaginal delivery achieved when two standards of care are used across a large population of women with indication for labor induction at Parkland Hospital. Eligible participants will include nulliparous and multiparous women at 37 weeks gestation or greater, with a living, singleton fetus and no major fetal malformations, in cephalic presentation, with intact membranes, no prior uterine scar, who qualify for prostaglandin administration and who have a cervical dilation of 2 centimeters or less, measured at the level of the internal os. Patients with non-reassuring fetal status, active herpes outbreak, a prior uterine scar, or any contraindication to prostaglandins (including 4 or more painful contractions per 10 minutes prior to prostaglandin administration) will be excluded from participation in the study.
Computer-generated cluster randomization will occur on a weekly basis for all study participants, to either the vaginal misoprostol regimen (study group) or to oral misoprostol regimen (control group).
According to the randomization protocol each week, participants will be randomized to either the oral misoprostol standard of care (control group) or vaginal misoprostol standard of care (study group). The study group will receive vaginal misoprostol 25 mcg every 3 hours for a maximum of 5 doses in those who meet criteria for prostaglandin administration. The control group will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Misoprostol will not be administered to patients who have progressed to active labor, defined as 4 centimeters cervical dilation. Intravenous oxytocin will be administered according to current PHHS protocol for both groups.
No direct contact between the research team and patients will be required, as this is a systematic comparison of two standards of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous and multiparous pregnant women
- •37 weeks gestation or greater
- •Living, singleton fetus
- •No major fetal malformations
- •Cephalic presentation
- •No prior uterine scar
- •Intact fetal membranes
- •Qualifies for prostaglandin administration according to current Parkland protocol
- •Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os
- •Have an indication for induction or attempted induction of labor according to Parkland protocol
排除标准
- •Non-reassuring fetal status
- •Active herpes outbreak
- •Prior uterine scar
- •Contraindication to prostaglandins according to current Parkland protocol (including 4 or more painful contractions per 10 min prior to prostaglandin administration)
- •Contraindication to vaginal delivery
结局指标
主要结局
Number of Participants with Vaginal Delivery
时间窗: at delivery
vaginal delivery at first induction
次要结局
- Time to Delivery(from start of induction agent to time of delivery)
- Need for Oxytocin(at delivery)
- Time (hours) of Oxytocin(at delivery)
- Number of Participants with Meconium-Stained Amniotic Fluid(at the time of rupture of membranes or at delivery)
- Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No)(at delivery)
- Number of Participants with Uterine Hyperstimulation Syndrome(at delivery)
- Number of Participants with Excess Blood Loss(at delivery)
- Number of Participants with Blood Transfusion(at delivery)
- Number of Participants with Uterine Rupture(at delivery)
- Number of Participants with a 5-minute Apgar Score Less Than 4(5 minutes after time of birth)
- Number of Participants with Neonatal Sepsis(from time of birth until time of discharge or up to 7 days of life, whichever comes first)
- Number of Participants with NICU Admission Order(from time of birth until the time of discharge or up to 7 days of life, whichever comes first.)
- Surgical Site Infection(from time of birth until the time of discharge, or up to 4 weeks postpartum)
- Number of Participants with Unplanned Hysterectomy(immediately after delivery to discharge from the hospital, or up to 4 weeks postpartum)
- Indication for Cesarean Delivery(at delivery)
- Use of Epidural During Labor(at delivery)
- Presence of Chorioamnionitis(at delivery)
- Number of Participants with Puerperal Fever and/or Endometritis(immediately after delivery to discharge from the hospital, or up to 4 weeks postpartum)
- Number of Participants with Umbilical pH <7.0(at delivery)
研究者
Emily Adhikari
Principal Investigator
University of Texas Southwestern Medical Center