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

NCT07690007 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-07-08

No results posted yet for this study

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

Interventions

DRUG

Misoprostol

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).

DEVICE

Misoprostol plus Cervical Balloon

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Ye Feng, M.D. · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-01
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07690007 on ClinicalTrials.gov