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Prevalence of Anal Sphincter Defects After Childbirth

Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05196620
Acronym
PRADA
Enrollment
100
Registered
2022-01-19
Start date
2024-06-01
Completion date
2025-12-31
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Problems, Fecal Incontinence

Keywords

Anal Ultrasound, Fecal Incontinence, Childbirth

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.

Interventions

OTHEREndoanal Ultrasound (EAUS)

Endoanal Ultrasound pre- and postpartum

Sponsors

Hospital Clínico Universitario Lozano Blesa
CollaboratorOTHER
Instituto de Investigación Sanitaria Aragón
CollaboratorOTHER
Universidad de Zaragoza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primiparous pregnant patients aged \>18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.

Exclusion criteria

* Non primiparous patients and patients with a history of anal surgery

Design outcomes

Primary

MeasureTime frameDescription
Integrity of anal sphincter4 monthsNo defect detected on EAUS
Defects on anal canal4 monthsDisruption of any of the anal canal sphincters

Secondary

MeasureTime frameDescription
QoL4 monthsAccording to a dedicated questionnaire

Countries

Spain

Contacts

Primary ContactJose-M Ramirez, Prof
jramirez@unizar.es+34639776364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026