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.
Age 20-45 years at delivery
Singleton pregnancy
Primiparous
Cephalic presentation
Multiple pregnancy
Contraindications to vaginal delivery
Mental disorders (depression or anxiety)
Preterm labor (< 37 weeks)
Parallel
Misoprostol
Drug25 μg misoprostol tablet placed in the posterior vaginal fornix for cervical ripening and labor induction on the first day. May be repeated up to 3-4 times based on uterine contraction response (monitored every 2-4 hours).
Misoprostol plus Cervical Balloon
DeviceA Cervical balloon with 80 mL sterile water inflation placed intracervically for mechanical cervical dilation. The balloon is left in place for up to 12-24 hours or until spontaneous expulsion.
Time from initiation of labor induction to delivery
Time in hours from the start of labor induction (placement of first dose of misoprostol or Foley balloon) to vaginal delivery or cesarean section.
Time from Induction to Amniotomy
Duration from the start of induction (placement of misoprostol or balloon+misoprostol) to the performance of amniotomy, measured in minutes.
Time from Induction to Spontaneous Membrane Rupture
Duration from the start of induction to spontaneous rupture of fetal membranes, measured in hours.
Time from Induction to Onset of Labor
Duration from the start of induction to the establishment of regular painful uterine contractions with cervical opening, measured in minutes.
Duration of Balloon Use
Total time the cervical balloon remains in place (from insertion to removal), measured in minutes.
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