Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up

NCT06542744 | Active Not Recruiting DMC

• 2 other identifiers: PeriFlex2023-A01980-45
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 15

Brief Summary

The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a time-limited exercise program specifically developed to optimize results, in adult, pregnant women with their first child (single fetus) less than 24 weeks of amenorrhea at the time of inclusion (i.e. during the 5th month of pregnancy). The main questions it aims to answer are:

• Does the Emagina training program improve perineal flexibility during pregnancy ?
• Does the Emagina training program reduce the proportion and importance of perineal tears, as well as the proportion of sutures and episiotomies during childbirth ? Researchers will compare Emagina group to a Control group (no intervention) to see if Emagina device works to improve perineum flexibility. Participants will :
• measure the flexibility of their perineum on 2 occasions 90 days apart, with or without perineal training
• perform perineal training with the Emagina medical device or follow current practice
• fill out e-questionnaires regarding quality of life, lifestyle, pelvic static disorders, sexual activity and urinary incontinence

Conditions

Pregnancy; Childbirth

Keywords

Pregnancy; Perineum; Perineal training; Perineal flexibility; Perineal trauma prevention; Pelvic floor disorder prevention; Delivery trauma; Episiotomies reduction; Perineal tearing prevention; Pelvic muscle injury; Vaginal delivery

Outcome Measures

Primary Outcomes (1)

• Maximum diameter of balloon expelled at D90

  To compare the flexibility of the perineum in primiparous subject having followed, during the pregnancy, the program of perineal training of the medical device Emagina during 90 days versus those having had a standard pregnancy follow-up

  Day 90

Secondary Outcomes (17)

• Comparison of the expulsive phase

  At Birth

• Comparison of perineal injuries

  At birth

• APGAR score of the baby at birth

  At Birth

• Height of the baby at birth

  At birth

• Weight of the baby at birth

  At birth

Study Arms (2)

Subjects using the Emagina Medical device

EXPERIMENTAL

Emagina Medical device

Device: Training with the Emagina device at home until birth

Control group

OTHER

Standard of Care (SOC)

Other: No intervention

Interventions

No intervention OTHER

The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.

Control group

Training with the Emagina device at home until birth DEVICE

The subjects will use the device at home according to a series of 3 exercises, 2 sessions per week, followed by a series of 4 exercises, 3 sessions per week starting from D75.

Subjects using the Emagina Medical device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• History of vaginal or perineal surgery prior to pregnancy
• Pelvic anomalies
• Vaginismus
• 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

Sponsors & Collaborators

• Mumming: lead

Study Sites (15)

Ornella Ferrari, 1 Bis Rue Castéja

Boulogne-Billancourt, 92100, France

Location

Annabelle Sallandre, 7 Rue Ambroise Paré

Coutances, 50200, France

Location

Solène Baradu, 5 Rue des Sports

Grandchamps-des-Fontaines, 44119, France

Location

Grazia Sabatino, 2 impasse du Gaz

Marseille, 13008, France

Location

Jennifer Denys, 53 rue de la Méditerranée

Montpellier, 34070, France

Location

Elsa Molinier, 127 Rue Maurice Béjart

Montpellier, 34080, France

Location

Alexandra Sasportas, 8 Boulevard de Magenta

Paris, 75010, France

Location

Alice Rault, 103 Avenue de la République

Paris, 75011, France

Location

Marion Alglave, 8 Rue Ernest Renan

Paris, 75015, France

Location

Sobiha Sbai, 370 Avenue Jean Jaurès

Ronchin, 59790, France

Location

Tiphaine Cartier, 45 Boulevard des Belges

Rouen, 76000, France

Location

Céline Vauclin, 1 Avenue Jacques Chastellain

Rouen, 76100, France

Location

Ariane Gasulla, 43 Rue Camille Claudel

Saint-Paul-lès-Dax, 40990, France

Location

Annabel Buzy, 39 avenue Jean Jaurès

Suresnes, 92150, France

Location

Karen Methia, 15 Allée du Gros Chêne

Verneuil-sur-Seine, 78480, France

Location

Study Officials

• David Desseauve, MD

  Centre Hospitalier Universitaire de Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: October 10, 2024
• Primary Completion: December 12, 2025
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (15)