Clinical trial NCT06542744: 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
Official title: A Prospective, Multicentric, Randomized Clinical Investigation Assessing the Impact of Perineal Training With the Emagina Medical Device on Perineal Flexibility During Pregnancy and Childbirth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Mumming
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum diameter of balloon expelled at D90
timeFrame: Day 90
Secondary outcomes:
measure: Comparison of the expulsive phase
timeFrame: At Birth
measure: Comparison of perineal injuries
timeFrame: At birth
measure: APGAR score of the baby at birth
timeFrame: At Birth
measure: Height of the baby at birth
timeFrame: At birth
measure: Weight of the baby at birth
timeFrame: At birth
measure: Head size of the baby at birth
timeFrame: At birth
measure: Sex of the baby
timeFrame: At birth
measure: Quality of life (SF-12)
timeFrame: Baseline and 2 months after birth
measure: Subject's satisfaction during delivery
timeFrame: 2 months after birth
measure: Postnatal pelvic statics disorders
timeFrame: At baseline and 2 months postpartum
measure: Postnatal return to normal sexual activity
timeFrame: At baseline and 2 months postpartum
measure: Postnatal urinary leakage
timeFrame: At baseline and 2 months postpartum
measure: Postnatal perineal rehabilitation session
timeFrame: 2 months after birth
measure: Variation of pressure exerted by the perineum during the flexibility measurement
timeFrame: At Day 0 and Day 90 visits
measure: Usability of the device
timeFrame: 2 months after birth
measure: Percentage of Compliance with the device
timeFrame: From baseline to birth
measure: Adverse events
timeFrame: From baseline through study completion, an average of 6 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Ornella Ferrari, 1 Bis Rue Castéja
city: Coutances
country: France
facility: Annabelle Sallandre, 7 Rue Ambroise Paré
city: Grandchamps-des-Fontaines
country: France
facility: Solène Baradu, 5 Rue des Sports
city: Marseille
country: France
facility: Grazia Sabatino, 2 impasse du Gaz
city: Montpellier
country: France
facility: Jennifer Denys, 53 rue de la Méditerranée
city: Montpellier
country: France
facility: Elsa Molinier, 127 Rue Maurice Béjart
city: Paris
country: France
facility: Alexandra Sasportas, 8 Boulevard de Magenta
city: Paris
country: France
facility: Alice Rault, 103 Avenue de la République
city: Paris
country: France
facility: Marion Alglave, 8 Rue Ernest Renan
city: Ronchin
country: France
facility: Sobiha Sbai, 370 Avenue Jean Jaurès
city: Rouen
country: France
facility: Tiphaine Cartier, 45 Boulevard des Belges
city: Rouen
country: France
facility: Céline Vauclin, 1 Avenue Jacques Chastellain
city: Saint-Paul-lès-Dax
country: France
facility: Ariane Gasulla, 43 Rue Camille Claudel
city: Suresnes
country: France
facility: Annabel Buzy, 39 avenue Jean Jaurès
city: Verneuil-sur-Seine
country: France
facility: Karen Methia, 15 Allée du Gros Chêne
Study officials:
affiliation: Centre Hospitalier Universitaire de Grenoble Alpes
name: David Desseauve, MD
role: PRINCIPAL_INVESTIGATOR
References: