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Balloon training could reduce birth injuries for new moms

NCT ID NCT06542744

Symptom relief Sponsor: Mumming 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called Emagina that uses a small balloon to train the pelvic floor muscles during pregnancy. The goal is to see if it makes the perineum more flexible and reduces tears or the need for stitches during childbirth. About 88 first-time mothers will either use the device or receive standard care, and their outcomes will be compared.

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 88 people

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

Started

Oct 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Women over 18 years of age * Singleton (fetus) * Primiparous subject * Subject less than 5 months pregnant (between 20 and 24 week of amenorrhea) * Subject affiliated to a social security plan * Subject who has given written consent prior to any specific procedure related to the clinical investigation * Subject able to understand and complete the clinical investigation questionnaires * Subject having a smartphone and being able to download the Emagina app Exclusion Criteria: * High-risk pregnancy (subjects presenting pregnancy-related risks will be excluded from participating in this clinical investigation, including risks of premature delivery, cases of symptomatically low-lying placenta and any contraindications to sexual relations) * Scheduled cesarean section prior to inclusion * History of vaginal or perineal surgery prior to pregnancy * Pelvic anomalies * Threatened preterm delivery prior to inclusion * Vaginismus * Use of Epi-no prior to inclusion * Collagenosis or other chronic disorders affecting collagen * Planned home birth * Nerve damage and other illnesses that reduce sensitivity to pain in the genital area (i.e. paraplegia, multiple sclerosis, diabetic neuropathy, medication that alters sensitivity in the genital area, vulvar varicose veins). * Persons deprived of liberty, under guardianship or trusteeship * Drug or alcohol abuse * Dementia, mental impairment, or psychiatric pathology that may compromise subject informed consent and/or compliance with the protocol and trial monitoring * Subject unable to comply with protocol monitoring for psychological, social, family or geographic reasons

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As listed by the trial registrant

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

Childbirth Pregnancy

Contacts and locations

Locations

  • Alexandra Sasportas, 8 Boulevard de Magenta

    Paris, 75010, France

  • Alice Rault, 103 Avenue de la République

    Paris, 75011, France

  • Annabel Buzy, 39 avenue Jean Jaurès

    Suresnes, 92150, France

  • Annabelle Sallandre, 7 Rue Ambroise Paré

    Coutances, 50200, France

  • Ariane Gasulla, 43 Rue Camille Claudel

    Saint-Paul-lès-Dax, 40990, France

  • Céline Vauclin, 1 Avenue Jacques Chastellain

    Rouen, 76100, France

  • Elsa Molinier, 127 Rue Maurice Béjart

    Montpellier, 34080, France

  • Grazia Sabatino, 2 impasse du Gaz

    Marseille, 13008, France

  • Jennifer Denys, 53 rue de la Méditerranée

    Montpellier, 34070, France

  • Karen Methia, 15 Allée du Gros Chêne

    Verneuil-sur-Seine, 78480, France

  • Marion Alglave, 8 Rue Ernest Renan

    Paris, 75015, France

  • Ornella Ferrari, 1 Bis Rue Castéja

    Boulogne-Billancourt, 92100, France

  • Sobiha Sbai, 370 Avenue Jean Jaurès

    Ronchin, 59790, France

  • Solène Baradu, 5 Rue des Sports

    Grandchamps-des-Fontaines, 44119, France

  • Tiphaine Cartier, 45 Boulevard des Belges

    Rouen, 76000, France

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