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

Starting soon · Phase 4

Conditions studied: Primiparous Women

In brief

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.

Key facts

Study ID
NCT07690007
Run by
Peking University First Hospital
People needed
220
Starts
2026-06-30
Expected to finish
2026-12-31
Last updated by the study team
2026-07-08

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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Full record on ClinicalTrials.gov

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