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Can a standardized approach to labor induction boost vaginal births?

NCT ID NCT07576881

Knowledge-focused Sponsor: Indiana University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether using a set method for cervical ripening (preparing the cervix for labor) leads to more vaginal deliveries. About 1,158 pregnant women will be randomly assigned to receive either a balloon catheter alone or a balloon catheter plus the medication misoprostol. The goal is to see if standardizing the process improves outcomes for mothers and babies.

What this could mean

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

Active substance
double balloon catheter and misoprostol
What this could lead to
If successful, this could establish a standard approach to cervical ripening that increases the chance of a vaginal delivery.
What could go wrong
This is an early-stage study (Phase 2/3) comparing two methods, so results may not show a clear benefit or may not apply to all hospitals.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,158 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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: * Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital * Willing and able to provide informed consent * Age ≥18 years old * Able to read, speak and understand English, Spanish or Haitian Creole Exclusion Criteria: * Premature rupture of membranes * Known chorioamnionitis * Fetal malpresentation * Placenta previa * Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study. * Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins) * Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management * Multiple gestation * Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon * Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm) * Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

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As listed by the trial registrant

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

Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

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