Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impac… (NCT07667660) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Denmark110 participantsStarted 2026-08-01
Plain-language summary
The aim of the ADAPT study is to investigate whether a structured, group-based follow-up programme can improve quality of life related to anal incontinence in women with OASI during the first year after childbirth. The study will also describe how symptoms change over time and assess effects on mental health, sexual function, symptoms of prolapse and urinary incontinence, and body image.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ICIQ-B Quality of Life Domain
Timeframe: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
2
Symptoms of Anal Incontinence (Cohort)
Timeframe: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months