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Can a higher dose of misoprostol help women with severe obesity avoid C-Section?

NCT ID NCT06199154

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a 50 microgram dose of misoprostol works better than a 25 microgram dose for starting labor in pregnant women with a BMI over 40. The goal is to see if the higher dose can lead to more vaginal deliveries and fewer cesarean sections. Participants will receive one of the two doses placed in the vagina every four hours until labor progresses.

What this could mean

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

Active substance
misoprostol (a medication used to induce labor)
What this could lead to
If a higher dose proves more effective, it could help more women with severe obesity achieve a vaginal delivery, reducing the need for cesarean sections and related surgical risks.
What could go wrong
This is an early-phase trial with a relatively small number of participants. The higher dose may not improve outcomes and could carry additional risks, such as excessive uterine contractions.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 162 people

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

Started

Jul 2024

Expected to finish

May 2027

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

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: * Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor * Speaks English or Spanish * Gestational age between 34 weeks and 0 days and 42 weeks and 6 days * Age 18 years old or older * Viable, single, cephalic fetus * Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm * Contractions \< 5 per 10 minutes Exclusion Criteria: * History of cesarean delivery * Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery) * Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load) * Contraindications to labor (cardiac, neurosurgical, need for cesarean) * Age \< 18yo * Fetal growth restriction with abnormal umbilical artery Doppler indices * Cervical dilation \>5 cm * Contractions \>5 per 10 minutes * Significant vaginal bleeding with concern for placental abruption * Non-reassuring fetal status or fetal heart rate decelerations * Fetal demise or major fetal anomaly * Inability to give consent

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Conditions

The condition(s) this trial relates to.

morbid obesity

As listed by the trial registrant

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

Morbid obesity 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

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

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