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 (PeriFlex)

A Prospective, Multicentric, Randomized Clinical Investigation Assessing the Impact of Perineal Training With the Emagina Medical Device on Perineal Flexibility During Pregnancy and Childbirth

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; Childbirth
• Intervention / Treatment: Device: Training with the Emagina device at home until birth; Other: No intervention

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Ornella Ferrari, 1 Bis Rue Castéja
  • Coutances, France, 50200
    • Annabelle Sallandre, 7 Rue Ambroise Paré
  • Grandchamps-des-Fontaines, France, 44119
    • Solène Baradu, 5 Rue des Sports
  • Marseille, France, 13008
    • Grazia Sabatino, 2 impasse du Gaz
  • Montpellier, France, 34070
    • Jennifer Denys, 53 rue de la Méditerranée
  • Montpellier, France, 34080
    • Elsa Molinier, 127 Rue Maurice Béjart
  • Paris, France, 75010
    • Alexandra Sasportas, 8 Boulevard de Magenta
  • Paris, France, 75011
    • Alice Rault, 103 Avenue de la République
  • Paris, France, 75015
    • Marion Alglave, 8 Rue Ernest Renan
  • Ronchin, France, 59790
    • Sobiha Sbai, 370 Avenue Jean Jaurès
  • Rouen, France, 76000
    • Tiphaine Cartier, 45 Boulevard des Belges
  • Rouen, France, 76100
    • Céline Vauclin, 1 Avenue Jacques Chastellain
  • Saint-Paul-lès-Dax, France, 40990
    • Ariane Gasulla, 43 Rue Camille Claudel
  • Suresnes, France, 92150
    • Annabel Buzy, 39 avenue Jean Jaurès
  • Verneuil-sur-Seine, France, 78480
    • Karen Methia, 15 Allée du Gros Chêne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects using the Emagina Medical device; Emagina Medical device	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.
Other: Control group; Standard of Care (SOC)	Other: No intervention; The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the expulsive phase	Expulsive phase will be defined with: the duration of the expulsive phase, the % of instrumental extraction (forceps, spatulas or vacuum-assisted delivery), the % of epidural anesthesia	At Birth
Comparison of perineal injuries	Perineal injuries will be defined with: the degree of perineal tears (according to the classification of perineal trauma), the % of grades 1, 2, 3, 4, the % of episiotomies, the % of perineal suture	At birth
APGAR score of the baby at birth	APGAR score at 1 minute, 5 minutes and 10 minutes after birth	At Birth
Height of the baby at birth	Height measured in cm	At birth
Weight of the baby at birth	Weight measured in g	At birth
Head size of the baby at birth	Head circumference measured in cm	At birth
Sex of the baby	Gender of the baby determined at birth	At birth
Quality of life (SF-12)	Quality of life assessed by the SF-12 and lifestyle assessed by a short survey	Baseline and 2 months after birth
Subject's satisfaction during delivery	Subject's satisfaction during delivery assessed by the QACE questionnaire	2 months after birth
Postnatal pelvic statics disorders	Pelvic statics disorders assessed by the PFIQ-7 questionnaire	At baseline and 2 months postpartum
Postnatal return to normal sexual activity	The % of subjects with return to normal sexual activity 2 months after delivery assessed by FSFI questionnaire (Yes/No),	At baseline and 2 months postpartum
Postnatal urinary leakage	the % of subjects with urinary leakage 2 months after delivery assessed by ICIQ-UI questionnaire	At baseline and 2 months postpartum
Postnatal perineal rehabilitation session	Number of perineal rehabilitation session prescribed by investigator	2 months after birth
Variation of pressure exerted by the perineum during the flexibility measurement	The variation of pressure exerted by the perineum during the flexibility measurement will be defined with following parameters: The pressure exerted while the balloon is fully inflated inside the vagina " IN ", The maximum pressure exerted during the expulsion of the balloon " EXP ", The pressure exerted when the balloon is outside " OUT ", Variation between IN and EXP defined as IN-EXP, Variation between EXP and OUT defined as EXP-OUT	At Day 0 and Day 90 visits
Usability of the device	Usability of Emagina assessed by the subjects through a questionnaire developed by the sponsor (i.e. ease of use of Emagina device, absence of technical issues while using Emagina device)	2 months after birth
Percentage of Compliance with the device	Percentage of Compliance assessed by the Emagina App and defined as the number of days of use divided on the theoretical days of use	From baseline to birth
Adverse events	Adverse events recorded from ICF (Informed Consent Form) signature until final visit including the rate of unscheduled cesarean sections	From baseline through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Mumming
• Investigators: Principal Investigator: David Desseauve, MD, Centre Hospitalier Universitaire de Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): December 12, 2025
• Study Completion (Estimated): October 10, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Vaginal delivery; Perineum; Perineal training; Perineal flexibility; Perineal trauma prevention; Pelvic floor disorder prevention; Delivery trauma; Episiotomies reduction; Perineal tearing prevention; Pelvic muscle injury
• Other Study ID Numbers: PeriFlex; 2023-A01980-45 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No