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Balloon vs. drug: which induces labor better for Slower-Growing babies?

NCT ID NCT05774236

Disease control Sponsor: Hospital Universitario 12 de Octubre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether a soft balloon (Cook's balloon) placed in the cervix is better than a vaginal medication (dinoprostone) for starting labor in full-term pregnancies where the baby is growing slowly. The main goal is to see which method leads to more vaginal deliveries and fewer cesarean sections. The study includes 172 women with a single baby in head-down position.

What this could mean

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

Active substance
Cook's balloon (mechanical cervical ripening device) and vaginal dinoprostone (medication)
What this could lead to
If the balloon works better, it could offer a safer, more effective way to induce labor in pregnancies with fetal growth restriction, reducing cesarean sections.
What could go wrong
This is a single trial with 172 participants, so results may not apply to all cases. Both methods carry risks like infection or fetal distress.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

172 people

The number who actually took part.

Started

Mar 2023

Finished

May 2025

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: * Singleton pregnancy * Age ≥ 18 years * Gestational age (GA) dated by first trimester ultrasound ≥ 37+0 weeks * Cephalic presentation * Stage I fetal growth restriction, defined as the presence of at least one of these two criteria: 1. Estimated fetal weight (EFW) \< 3rd percentile 2. EFW \< 10th percentile and at least one of the following: 2.1) Umbilical artery pulsatility index \> 95th percentile or 2.2) Cerebral-placental index \< 5th percentile * Bishop score \< 7 * Intact fetal membranes * No previous caesarean section * No contraindications for vaginal delivery or labor induction. Exclusion Criteria: * Major fetal malformation * Fetal genetic abnormality * Fetal congenital infection

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Conditions

The condition(s) this trial relates to.

fetal growth restriction

As listed by the trial registrant

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

Fetal growth retardation

Contacts and locations

Locations

  • Hospital Clinic i Provincial

    Barcelona, Barcelona, 08028, Spain

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia, Murcia, 30120, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitari Vall d&#39;Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

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