Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Mumming
Conditions:
Pregnancy
Childbirth
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06542744
Start Date
October 15 2024
End Date
October 1 2025
Last Update
August 7 2024
Active Locations (15)
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1
Ornella Ferrari, 1 Bis Rue Castéja
Boulogne-Billancourt, France, 92100
2
Annabelle Sallandre, 7 Rue Ambroise Paré
Coutances, France, 50200
3
Solène Baradu, 5 Rue des Sports
Grandchamps-des-Fontaines, France, 44119
4
Grazia Sabatino, 2 impasse du Gaz
Marseille, France, 13008