Recruiting

NCT Number: NCT07336017

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

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.

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Key information

Conditions

Anal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Eva FUSS, MD

SUB_INVESTIGATOR

Lise LECOINTRE, MD

CONTACT

[email protected]

33 3 88 12 74 72

Lise LECOINTRE, MD

PRINCIPAL_INVESTIGATOR

Lucie VOGT-SCHILB, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LECOINTRE, MD

CONTACT

[email protected]

33 3 88 12 74 7

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: IIA-LOSA

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 13, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting