Impact on Postpartum Anal Incontinence of an Educational Program for Delivery Room Staff (IIA-LOSA)

January 2, 2026 updated by: University Hospital, Strasbourg, France

Impact on Postpartum Anal Incontinence of an Educational Program for Delivery Room Staff on the Diagnosis and Repair of Obstetric Anal Sphincter Injuries

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
        • Principal Investigator:
          • Lise LECOINTRE, MD
        • Contact:
        • Principal Investigator:
          • Lucie VOGT-SCHILB, MD
        • Sub-Investigator:
          • Eva FUSS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. Mark's score
Time Frame: 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
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 17, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9694

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Incontinence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe