Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention (ADAPT)

Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstetric Anal Sphincter Injury
• Intervention / Treatment: Other: Group Session

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Jango, MD, PhD, Associate Professor; Phone Number: +4538681612; Email: hanna.margareta.jangoe@regionh.dk
• Study Contact Backup: Name: Iben O Hansen, MD; Phone Number: +4538689904; Email: iben.onsberg.hansen@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Department of Gynecology and Obstetrics at Herlev Hospital
      • Contact: Hanna Jango, MD, PhD, Associate Professor; Phone Number: +4538681612; Email: hanna.margareta.jangoe@regionh.dk
      • Contact: Iben O Hansen, MD; Phone Number: +4538689904; Email: iben.onsberg.hansen@regionh.dk
      • Sub-Investigator: Iben O Hansen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants are randomized 1:1 Intervention vs. control. Participants in the Control Group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the intervention group.
Active Comparator: Intervention; Participants are randomized 1:1 Intervention vs. control. Participants in the Intervention Group are invited to three group sessions 2-6 months postpartum hosted by doctors and physiotherapists. The group session focus on relevant information, physiotherapist-guided kegel-exercises (pelvic floor mucles exercises) and social interaction between participants. In addition the Intervention group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the control group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICIQ-B Quality of Life Domain	The change in score of the "Quality of Life" Domain in ICIQ-Bowel (Questions 19-23) between the Intervention and the Control Group	From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
Symptoms of Anal Incontinence (Cohort)	Development/fluctuation of anal incontinence and related symptoms for all participants regardless of randomization (cohort) at all timepoints.	From 8-14 days and at 1-1.5, 3, 6 and 9-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICIQ-B (total) score	The change in total ICIQ-Bowel score (all domains). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.	From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
Anal Incontinence symptoms	Anal Incontinence symptoms derived from early + late clinical follow-up and relevant ICIQ-B items. Between the Intervention and the Control group at all timepoints.	From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
EAUS	Assessment of defects in anal sphincter complex by endoanal ultrasound . Between the Intervention and the Control group, and for all participants (the cohort).	At 9-12 months clinical follow-up
Wound dehiscence	Wound dehiscence at early clinical follow-up (8-14 days). Wound dehiscence is divided into with/without involvement of pelvic muscles (With/without involvement of sphincter-complex or total dehiscence). Between the Intervention and the Control group, and for all participants (the cohort)	At early clinical follow-up (8-14 days postpartum)
Infection	Wound infection at early clinical follow-up are described by Redness, Edema, Echymosis, dicharge (pus), absces. Women with absces/pus or treated with antibiotics due to infection signs are considered to have a wound infection. Between the Intervention and the Control group, and for all participants (the cohort).	At early clinical follow-up (8-14 days postpartum)
Prolapse	Prolapse at 9-12 months clinical follow-up using modified POP-Q. Between the Intervention and the Control group, and for all participants (the cohort).	At 9-12 months clinical follow-up
Urinary incontinence	Symptoms of urinary incontinence from questionnaires (ICIQ-UI-SF) at 3, 6 and 9-12 months. Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.	At 3, 6 and 9-12 months postpartum
Pelvic symptoms	Symptoms of prolaps, heavyness, pain from questionnaires (PFDI-20, KAPTAIN). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.	At baseline, 3, 6 and 9-12 months
Number of clinical follow-ups	Number of clinical follow-ups due to e.g. wound complications or symptoms during the first year postpartum. Between the Intervention and the Control group, and for all participants (the cohort)	From delivery to 12 months postpartum
EPDS	Score of Edinburgh postpartum Depression Scale (EPDS) at baseline and 9-12 months. Between the Intervention and the Control group, and for all participants (the cohort) the development over time.	Baseline (1-1.5 months) and 9-12 months
Body Image	Body image score (FGSIS) at 9-12 months for the intervention and the control group , and for all participants in the cohort	Questionnaire at 9-12 months postpartum
Sexual function	Sexual function at 6 and 9-12 months questionnaire (ICIQ-VS + KAPTAIN). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.	6 and 9-12 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levator Ani Avulsion	Assessment of levator Ani Avulsion from Endovaginal Ultrasound. Presence, severity and association with symptoms and Quality of Life. Between the Intervention and the Control group at all timepoints, and for all participants (the cohort).	At 9-12 months clinical follow-up
Qualitative Component (Intervention group only)	Semi-structured individual or focus-group interviews will explore participants' experiences with the intervention and explore women's experiences of sustaining a perineal tear and any associated symptoms	Aprox. 2-8 weeks after concluded intervention

Collaborators and Investigators

• Sponsor: Hanna Jangö
• Investigators: Principal Investigator: Hanna Jango, MD, PhD, Associate Professor, Department of Gynecology and Obstetrics at Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: women's health; anal incontinence; obstetric anal sphincter injury; obstetric tear
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Behavioral Symptoms; Elimination Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Encopresis
• Other Study ID Numbers: H-26012116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No