Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542744
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeriFlex
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 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 ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None