Group-based follow-up for women after obstetric anal sphincter injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares a structured, group-based follow-up program to standard care in women with obstetric anal sphincter injury (OASI) within the first year after delivery. Participants complete questionnaires at multiple time points and may receive a clinical exam with pelvic ultrasound. The intervention includes three group sessions with focus on pelvic floor exercises, incontinence, emotions, sexual life, and daily challenges. Outcomes include quality of life related to anal incontinence, mental health, sexual function, prolapse and urinary symptoms, and body image.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up postpartum at the "Pelvic Clinic" at Herlev Hospital
* 18 years of age or above and the capacity to provide informed consent
* Fluent in Danish language

Exclusion Criteria:

* Referred patients from other hospitals due to complicated healing
* Patients where other Hospitals are responsible for the clinical follow-up

Where it's running

• Department of Gynecology and Obstetrics at Herlev Hospital
  Herlev, Capital Region, Denmark Recruiting

Study contacts

• Principal investigator: Hanna Jango, MD, PhD, Associate Professor — Department of Gynecology and Obstetrics at Herlev Hospital
• Study coordinator: Hanna Jango, MD, PhD, Associate Professor
• Email: hanna.margareta.jangoe@regionh.dk
• Phone: +4538681612

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery

  This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.

  Recruiting University of Sao Paulo · Ribeirão Preto, São Paulo · NCT07170007

• Pelvic floor exercise program for weak anal sphincter after childbirth

  This program will try guided pelvic floor exercises to see if they improve anal squeeze strength in women who had an obstetric anal sphincter injury and low anorectal manometry readings.

  Recruiting King's College Hospital NHS Trust · London · NCT07062731

• Evaluating 3D Ultrasound for Anal Sphincter Assessment

  This study is testing new 3D ultrasound techniques to see how well they can check the condition of the anal sphincter in pregnant women and new mothers to better understand related injuries and symptoms.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna · NCT06773520

• Care pathways for women with obstetric anal sphincter injury-related incontinence

  This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.

  Recruiting London North West Healthcare NHS Trust · London · NCT06143072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.