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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
104
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.
The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.
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
...and 5 more locations
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
Time frame: Day 90
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
Time frame: 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
Time frame: At birth
APGAR score of the baby at birth
APGAR score at 1 minute, 5 minutes and 10 minutes after birth
Time frame: At Birth
Height of the baby at birth
Height measured in cm
Time frame: At birth
Weight of the baby at birth
Weight measured in g
Time frame: At birth
Head size of the baby at birth
Head circumference measured in cm
Time frame: At birth
Sex of the baby
Gender of the baby determined at birth
Time frame: At birth
Quality of life (SF-12)
Quality of life assessed by the SF-12 and lifestyle assessed by a short survey
Time frame: Baseline and 2 months after birth
Subject's satisfaction during delivery
Subject's satisfaction during delivery assessed by the QACE questionnaire
Time frame: 2 months after birth
Postnatal pelvic statics disorders
Pelvic statics disorders assessed by the PFIQ-7 questionnaire
Time frame: 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),
Time frame: At baseline and 2 months postpartum
Postnatal urinary leakage
the % of subjects with urinary leakage 2 months after delivery assessed by ICIQ-UI questionnaire
Time frame: At baseline and 2 months postpartum
Postnatal perineal rehabilitation session
Number of perineal rehabilitation session prescribed by investigator
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline through study completion, an average of 6 months
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