Could a balloon and a pill speed up labor induction?
NCT ID NCT07690007
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study tests whether using a cervical balloon along with the medication misoprostol on the first day of labor induction can shorten the time from start to delivery in first-time mothers. Participants are randomly assigned to receive either misoprostol alone or misoprostol plus a balloon. The trial measures delivery time and monitors safety for both mother and baby.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- misoprostol and cervical balloon
- What this could lead to
- If the combination works, it could shorten labor for first-time mothers and reduce complications, offering a safer, faster induction method.
- What could go wrong
- This is a single, mid-sized trial in one country, so results may not apply everywhere. Both methods have known risks like uterine overstimulation or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 20-45 years at delivery * Singleton pregnancy * Primiparous * Cephalic presentation * Cervical Bishop score ≤ 5 * No history of stillbirth Exclusion Criteria: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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