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Recruiting Observational

Impact on Postpartum Anal Incontinence of an Educational Program for Delivery Room Staff

NCT07336017 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-06-17
Last updated
2026-01-13

Condition(s) studied

Anal Incontinence

Study summary

Obstetric anal sphincter injuries are a source of significant short-term (pain, bleeding, infection, suture dehiscence), medium-term (anorectovaginal fistulas, sexual dysfunction), and long-term (anal incontinence in 30-60% of cases) morbidity. However, they are underdiagnosed and sometimes poorly repaired due to technical difficulties, the use of inappropriate surgical techniques, or a lack of awareness of their significant long-term morbidity. These diagnostic and therapeutic errors, however, significantly worsen the functional prognosis of patients. This study aims to evaluate the clinical impact of an educational program designed for continuing education in the diagnosis and repair of obstetric anal sphincter injuries for staff working in the delivery room.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult women (≥18 years old) * who gave birth vaginally at Strasbourg University Hospital in the 3 months prior to and 3 months following the training of delivery room staff at both maternity wards * Singleton pregnancy * Live birth Exclusion Criteria: * Multiple pregnancy * Fetal death in utero * Medical termination of pregnancy * Delivery by cesarean section.

Primary outcome measure(s)

  • St. Mark's score — Up to 18 months
    The St Mark's score is a tool for measuring the severity of fecal incontinence: The score is based on several criteria: Solid leakage: 2 points (1-3 times per month) Liquid leakage: 3 points (once a week) Gas: 1 point (less than once a week) Protection: 1 point (occasionally) Daily life: 2 points (moderate discomfort) Ability to control: 1 point The points for each criterion are added together: * Minimum score = 0 → no incontinence. * Maximum score = 24 → very severe incontinence

Trial sites (1)

FacilityCityRegionStatus
Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07336017 on ClinicalTrials.gov ↗ ← All trials in France