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

A Prospective, Multicentric, Randomized Clinical Investigation Assessing the Impact of Perineal Training With the Emagina Medical Device on Perineal Flexibility During Pregnancy and Childbirth

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Mumming · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pregnancy
• Childbirth

Interventions

Type	Name	Description
DEVICE	Training with the Emagina device at home until birth	The subjects will use the device at home according to a series of 3 exercises, 2 sessions per week, followed by a series of 4 exercises, 3 sessions per week starting from D75.
OTHER	No intervention	The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

15 sites across 1 country: France