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Balloon method may reduce C-Sections in obese women at term

NCT ID NCT07685756

Disease control Sponsor: HUDDA Ahmad Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial compares two methods for preparing the cervix before inducing labor in obese women (BMI over 30) who are at full term (37+ weeks). One method uses a small balloon inserted into the cervix, the other uses a vaginal medication called misoprostol. The goal is to see which approach leads to fewer emergency C-sections or instrument-assisted deliveries. The study includes 108 women with a low Bishop score (under 6), meaning their cervix is not yet ready for labor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cervical ripening balloon (device) and misoprostol (drug)
What this could lead to
If the balloon works better, it could offer a safer, more effective way to induce labor in obese women, potentially lowering C-section rates.
What could go wrong
This is a small, single-center trial, so results may not apply widely. Both methods carry risks like infection or uterine hyperstimulation.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * obese women bmi \>30, Bishop score \<6 at time of ripening Singleton pregnancy Gestational age more than 37 weeks Exclusion Criteria: * pregnancy with fetal demise congenital anomalies, History of uterine surgery In active labour \>4 cm dialated Obs complication History of uterine hyper stimulation and uterine rupture Feel malpresentation

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical ripening

Contacts and locations

Locations

  • Pakistan institute of medical sciences Islamabad

    Islamabad, Punjab Province, 46604, Pakistan

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