Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagi… (NCT06542744) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
France88 participantsStarted 2024-10-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.