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
NCT ID: NCT06542744
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2024-10-15
2025-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Subjects using the Emagina Medical device
Emagina Medical device
Training with the Emagina device at home until birth
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.
Control group
Standard of Care (SOC)
No intervention
The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.
Interventions
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Training with the Emagina device at home until birth
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.
No intervention
The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Mumming
INDUSTRY
Responsible Party
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Principal Investigators
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David Desseauve, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Grenoble Alpes
Locations
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Ornella Ferrari, 1 Bis Rue Castéja
Boulogne-Billancourt, , France
Annabelle Sallandre, 7 Rue Ambroise Paré
Coutances, , France
Solène Baradu, 5 Rue des Sports
Grandchamps-des-Fontaines, , France
Grazia Sabatino, 2 impasse du Gaz
Marseille, , France
Jennifer Denys, 53 rue de la Méditerranée
Montpellier, , France
Elsa Molinier, 127 Rue Maurice Béjart
Montpellier, , France
Alexandra Sasportas, 8 Boulevard de Magenta
Paris, , France
Alice Rault, 103 Avenue de la République
Paris, , France
Marion Alglave, 8 Rue Ernest Renan
Paris, , France
Sobiha Sbai, 370 Avenue Jean Jaurès
Ronchin, , France
Tiphaine Cartier, 45 Boulevard des Belges
Rouen, , France
Céline Vauclin, 1 Avenue Jacques Chastellain
Rouen, , France
Ariane Gasulla, 43 Rue Camille Claudel
Saint-Paul-lès-Dax, , France
Annabel Buzy, 39 avenue Jean Jaurès
Suresnes, , France
Karen Methia, 15 Allée du Gros Chêne
Verneuil-sur-Seine, , France
Countries
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Central Contacts
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Facility Contacts
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Annabelle Sallandre
Role: primary
Solène Baradu
Role: primary
Grazia Sabatino
Role: primary
Jennifer Denys
Role: primary
Alexandra Sasportas
Role: primary
Alice Rault
Role: primary
Marion Alglave
Role: primary
Sobiha Sbai
Role: primary
Tiphaine Cartier
Role: primary
Céline Vauclin
Role: primary
Ariane Gasulla
Role: primary
Annabel Buzy
Role: primary
Karen Methia
Role: primary
Other Identifiers
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2023-A01980-45
Identifier Type: OTHER
Identifier Source: secondary_id
PeriFlex
Identifier Type: -
Identifier Source: org_study_id
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