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)

Mumming

Status: Not yet enrolling

Conditions: Childbirth; Pregnancy

Treatments: Other: No intervention; Device: Training with the Emagina device at home until birth

Study type: Interventional

Funder types: Industry

Identifiers

NCT06542744

PeriFlex

2023-A01980-45 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Subjects using the Emagina Medical device

Experimental group

Description:

Emagina Medical device

Treatment:

Device: Training with the Emagina device at home until birth

Control group

Other group

Description:

Standard of Care (SOC)

Treatment:

Other: No intervention