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 Number: NCT06542744
Acronym: PeriFlex
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy|Childbirth
Interventions: DEVICE: Training with the Emagina device at home until birth|OTHER: No intervention
Sponsor: Mumming
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10-15
Completion Date: 2025-10
Locations: Ornella Ferrari, 1 Bis Rue Castéja, Boulogne-Billancourt, 92100, France|Annabelle Sallandre, 7 Rue Ambroise Paré, Coutances, 50200, France|Solène Baradu, 5 Rue des Sports, Grandchamps-des-Fontaines, 44119, France|Grazia Sabatino, 2 impasse du Gaz, Marseille, 13008, France|Jennifer Denys, 53 rue de la Méditerranée, Montpellier, 34070, France|Elsa Molinier, 127 Rue Maurice Béjart, Montpellier, 34080, France|Alexandra Sasportas, 8 Boulevard de Magenta, Paris, 75010, France|Alice Rault, 103 Avenue de la République, Paris, 75011, France|Marion Alglave, 8 Rue Ernest Renan, Paris, 75015, France|Sobiha Sbai, 370 Avenue Jean Jaurès, Ronchin, 59790, France|Tiphaine Cartier, 45 Boulevard des Belges, Rouen, 76000, France|Céline Vauclin, 1 Avenue Jacques Chastellain, Rouen, 76100, France|Ariane Gasulla, 43 Rue Camille Claudel, Saint-Paul-lès-Dax, 40990, France|Annabel Buzy, 39 avenue Jean Jaurès, Suresnes, 92150, France|Karen Methia, 15 Allée du Gros Chêne, Verneuil-sur-Seine, 78480, France

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

Primary Outcome Measures: 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: 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