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

NCT07336017 | Recruiting

• 1 other identifier: 9694
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Incontinence

Keywords

Anal Incontinence; Postpartum Anal Incontinence; Obstetric Anal Sphincter Injuries

Outcome Measures

Primary Outcomes (1)

• St. Mark's score

  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

  Up to 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy
• Fetal death in utero
• Medical termination of pregnancy
• Delivery by cesarean section.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Lise LECOINTRE, MD

CONTACT

33 3 88 12 74 7; lise.lecointre@chu-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: June 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

FR (1)