Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05196620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Anal Sphincter Defects After Childbirth
Sponsor:
Universidad de Zaragoza
Organization:
Study Overview
Official Title:
Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRADA
Brief Summary:
The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-
Detailed Description:
The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.
It is of great importance not only an early detection but to indicates the best possible management as soon as posible.
The design is a prospective observational study including primiparous woman, without previous anal surgery.
It is of great importance not only an early detection but to indicates the best possible management as soon as posible.
The design is a prospective observational study including primiparous woman, without previous anal surgery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: