Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group Session.
- Who it may be relevant to
- Registry conditions: Obstetric Anal Sphincter Injury. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial
Overview
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.
Detailed description
Women who experience a birth tear involving the anal sphincter (OASI) currently lack a systematic and consistent follow-up programme. There is limited knowledge about how their symptoms develop during the first year after childbirth, and problems such as anal incontinence are likely underreported due to stigma. Studies show women are asking for better support, information, and guidance.
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.
The study is a randomised controlled trial with a 1:1 allocation to either a group-based follow-up programme or standard care. All participants complete questionnaires at 1-1.5 months, 3, 6, and 9-12 months after childbirth, and are offered a clinical examination at 9-12 months postpartum. This includes a gynaecological assessment and 3D endoanal and endovaginal ultrasound.
In addition, the intervention group takes part in three group sessions focusing on healing, physiotherapist-guided pelvic floor muscle exercises, incontinence, emotions, sexual life, and everyday challenges.
Interventions
- Other Group Session
Participants in the Intervention Group are invited to three closed group sessions 2-6 months postpartum hosted by doctors and physiotherapists. The group session focus on relevant information (e.g. healing, incontinence, emotions, concerns, sexlife, everyday challenges), kegel-exercises (pelvic floor exercises) and social interaction between participants.
Primary outcome measures
- ICIQ-B Quality of Life Domain [Time frame: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum]
- Symptoms of Anal Incontinence (Cohort) [Time frame: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months]
Secondary outcome measures (12)
- ICIQ-B (total) score [Time frame: From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum]
- Anal Incontinence symptoms [Time frame: From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months]
- EAUS [Time frame: At 9-12 months clinical follow-up]
- Wound dehiscence [Time frame: At early clinical follow-up (8-14 days postpartum)]
- Infection [Time frame: At early clinical follow-up (8-14 days postpartum)]
- Prolapse [Time frame: At 9-12 months clinical follow-up]
- Urinary incontinence [Time frame: At 3, 6 and 9-12 months postpartum]
- Pelvic symptoms [Time frame: At baseline, 3, 6 and 9-12 months]
- Number of clinical follow-ups [Time frame: From delivery to 12 months postpartum]
- EPDS [Time frame: Baseline (1-1.5 months), 6 months and 9-12 months]
- Body Image [Time frame: Questionnaire at 6 months and 9-12 months postpartum]
- Sexual function [Time frame: 6 and 9-12 months postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Department of Gynecology and Obstetrics at Herlev Hospital — Herlev
Identifiers
NCT: NCT07667660 · H-26012116