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Balloon vs. drugs: could a simple device make labor induction safer for moms with scarred uteri?

NCT ID NCT03471858

Symptom relief Sponsor: Ministry of Health, Singapore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared using a cervical balloon catheter (a soft tube with a balloon) to prostaglandin drugs for inducing labor in 44 women who had a previous C-section. The goal was to see if the balloon method is safer and just as effective. The trial is now complete, and results may help guide safer choices for women attempting a vaginal birth after a C-section.

What this could mean

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

Active substance
cervical balloon catheter
What this could lead to
If successful, this could offer a safer way to induce labor for women who have had a previous C-section, reducing the risk of uterine rupture.
What could go wrong
This is a small, completed trial with only 44 participants, so results may not apply to all women. The balloon method may be less effective than drugs in some cases.

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

44 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 2025

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 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female ≥ 21 years of age at booking visit * 1 previous uncomplicated lower segment caesarean section (CS) * Aiming for TOLAC * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study * Singleton pregnancy * Gestational age \>37 weeks * Understands risk of TOLAC * Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation * Unfavourable Bishop's Score ≤ 5 requiring cervical priming * Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC * Reactive CTG pre-induction * Ruptured membranes Exclusion Criteria: * Refusal to participate * Women with 2 or more previous CS * Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery * Previous uterine surgery with contra-indication to future TOLAC * Maternal contraindication for vaginal delivery * Fetal contraindication for vaginal delivery or major fetal abnormality * Malpresentation or cord presentation * Placenta praevia \<20mm from internal os * Chorioamnionitis * Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC * Suspected fetal macrosomia (estimated weight on ultrasound \>4kg) AND deemed a contraindication for TOLAC * Congenital uterine abnormality * Multifetal pregnancy * Latex allergy or poorly-controlled asthma

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Conditions

The condition(s) this trial relates to.

Obstetric Labor Complications pregnancy disorder

As listed by the trial registrant

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

Cesarean section; dehiscence Labor complication Pregnancy related

Contacts and locations

Locations

  • National University Hospital, Singapore

    Singapore, 679973, Singapore

More trials for these conditions

Other studies related to the condition(s) this trial covers.