Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas

NCT07690007 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025R0393-0002
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primiparous Women

Keywords

labor induction; misoprostol; foley balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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 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).

Secondary Outcomes (20)

• 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

Study Arms (2)

Misoprostol Plus Cervical Balloon

EXPERIMENTAL

Participants receive 25 μg misoprostol placed in the posterior vaginal fornix, combined with a Cervical balloon catheter (80 mL inflation) placed intracervically for 12-24 hours on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response.

Device: Misoprostol plus Cervical Balloon

Misoprostol Alone

ACTIVE COMPARATOR

Participants receive 25 μg misoprostol placed in the posterior vaginal fornix alone on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response.

Drug: Misoprostol

Interventions

Misoprostol DRUG

25 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 Alone

Misoprostol plus Cervical Balloon DEVICE

A 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.

Misoprostol Plus Cervical Balloon

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-45 years at delivery
• Singleton pregnancy
• Primiparous
• Cephalic presentation
• Cervical Bishop score ≤ 5
• No history of stillbirth

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ye Feng, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Feng, M.D.

CONTACT

8618001203634; fengye_bjmu@163.com

Jianhua Niu, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share