Efficacy of Intravaginal Misoprostol Combined With Cervical Balloon Versus Misoprostol Alone for Induction of Labor on the First Day in Primiparous Women: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Time from initiation of labor induction to delivery
研究概览
简要总结
Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Some meta-analyses have suggested that combined use may shorten the duration of labor, reduce the frequency of tachysystole, and lower NICU admission rates without increasing the risk of cesarean section. However, existing studies are heterogeneous and lack data from Asian populations.
This study is being done to see whether combining two common methods of labor induction-misoprostol (a medicine placed in the vagina) and a cervical balloon (placed in the cervix) on the first day of induction-can shorten the time from the start of induction to delivery in first-time mothers during pregnancy .
Participants will be randomly assigned to one of two groups: one group will receive misoprostol alone (standard care) on the first day of induction, and the other group will receive misoprostol plus a cervical balloon on the first day of induction. The main outcome measured is the time from the start of induction to delivery. The study will also look at safety outcomes, including the rate of cesarean section, maternal complications, and newborn outcomes.
详细描述
This is a single-center, randomized, open-label, superiority randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (misoprostol plus cervical balloon on the first day of induction) or the control group (misoprostol alone on the first day of induction).
IPRIMARY OUTCOME:
Time from initiation of labor induction to delivery (hours).
SECONDARY OUTCOMES:
Time from induction to amniotomy (min), time from induction to spontaneous membrane rupture (h), time from induction to onset of labor (min), duration of balloon use (min), duration of oxytocin use (min), duration of latent phase (h), duration of first and second stages of labor (min), mode of delivery, degree of perineal laceration, indications for forceps/episiotomy/cesarean section, fetal distress, intrauterine infection, neonatal outcomes (birth weight, Apgar score, umbilical artery pH/BE, NICU admission), and maternal hemoglobin difference before and after delivery. Safety outcomes include placental abruption, septic shock, and severe postpartum hemorrhage.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-45 years at delivery
- •Singleton pregnancy
- •Primiparous
- •Cephalic presentation
- •Cervical Bishop score ≤ 5
- •No history of stillbirth
排除标准
- •Multiple pregnancy
- •Contraindications to vaginal delivery
- •Mental disorders (depression or anxiety)
- •Preterm labor (< 37 weeks)
- •Intrauterine fetal death
- •Previous uterine surgery
- •Premature rupture of membranes
- •Abnormal fetal heart rate tracing
结局指标
主要结局
Time from initiation of labor induction to delivery
时间窗: Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).
Time in hours from the start of labor induction (placement of first dose of misoprostol or Foley balloon) to vaginal delivery or cesarean section.
次要结局
- Time from Induction to Amniotomy(From start of induction to amniotomy)
- Time from Induction to Spontaneous Membrane Rupture(From start of induction to spontaneous rupture)
- Time from Induction to Onset of Labor(From start of induction to onset of labor)
- Duration of Balloon Use(From balloon insertion to removal, assessed during the induction period (up to 24 hours).)
- Duration of Oxytocin Use(From start to stop of oxytocin infusion, assessed during labor)
- Duration of Latent Phase of Labor(From onset of labor to active phase, assessed during labor)
- Duration of First and Second Stages of Labor(From full dilation to delivery, assessed during the second stage)
- Mode of Delivery(At the time of delivery.)
- Degree of Perineal Laceration(Immediately after vaginal delivery.)
- Indications for Forceps/Episiotomy/Cesarean Section(At the time of the operative intervention (during labor/delivery).)
- Fetal Distress(During labor, assessed up to delivery.)
- Intrauterine Infection(During labor and up to 48 hours postpartum.)
- Neonatal Birth Weight(At delivery (immediately after birth).)
- Apgar Score(At 1 and 5 minutes after birth.)
- Umbilical Artery pH and Base Excess(Immediately after delivery (from cord blood).)
- NICU Admission(After birth.)
- Maternal Hemoglobin Difference(Baseline (before induction) and within 24-48 hours after delivery.)
- Placental Abruption(During labor and delivery)
- Septic Shock(Before or after birth)
- Severe Postpartum Hemorrhage(Within 24 hours after delivery.)