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

Launched by MUMMING · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether using a special medical device called Emagina can help improve the flexibility of the perineum in pregnant women who are having their first child. The perineum is the area between the vagina and the anus, and its flexibility can affect childbirth. The trial will compare women using the Emagina device to those who receive standard pregnancy care, to see if using the device can help reduce tearing and the need for stitches during delivery.

To participate in this study, women must be at least 18 years old, pregnant with their first child (and less than 24 weeks along), and able to use a smartphone app. Participants will undergo perineal training with the Emagina device or follow normal care, and they will complete questionnaires about their quality of life and experiences during pregnancy. The trial is not yet recruiting, but it aims to provide valuable insights into how this device might support women during childbirth.

Gender

FEMALE

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