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NCT Number: NCT07667660

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

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.

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Key information

Conditions

Obstetric Anal Sphincter Injury 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

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Group Session

Other

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 outcomes

  1. ICIQ-B Quality of Life Domain

    Time frame: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum

    The change in score of the "Quality of Life" Domain in ICIQ-Bowel (Questions 19-23) between the Intervention and the Control Group.

    ICIQ-B: "International Consultation on Incontinence Questionnaire-Bowel"

    The ICIQ-B score contains 21 items, 17 of the 21 items are scored items, while the remaining four are unscored 9. Each item is scored on an ordinal scale and contains a 'bother' score rated on a numeric rank scale (NRS). The bother scores are not part of the calculated subscale scores. The 17 scored items are divided into three subscales:

    Bowel pattern (0-21), bowel control (0-28) and Quality of life (0-26), with a higher score indicating more symptoms.

  2. Symptoms of Anal Incontinence (Cohort)

    Time frame: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months

    Development/fluctuation of anal incontinence and related symptoms for all participants regardless of randomization (cohort) at all timepoints.

    From questionnaires and clinical follow-up. No score/scale is used.

Secondary outcomes

  1. ICIQ-B (total) score

    Time frame: From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum

    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.

    ICIQ-B: "International Consultation on Incontinence Questionnaire-Bowel"

    The ICIQ-B score contains 21 items, 17 of the 21 items are scored items, while the remaining four are unscored 9. Each item is scored on an ordinal scale and contains a 'bother' score rated on a numeric rank scale (NRS). The bother scores are not part of the calculated subscale scores. The 17 scored items are divided into three subscales:

    Bowel pattern (0-21), bowel control (0-28) and Quality of life (0-26), with a higher score indicating more symptoms.

  2. Anal Incontinence symptoms

    Time frame: From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months

    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. No score/scale is used.

  3. EAUS

    Time frame: At 9-12 months clinical follow-up

    Assessment of defects in anal sphincter complex by endoanal ultrasound . Between the Intervention and the Control group, and for all participants (the cohort). No score/scale is used.

  4. Wound dehiscence

    Time frame: At early clinical follow-up (8-14 days postpartum)

    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). No score/scale is used.

  5. Infection

    Time frame: At early clinical follow-up (8-14 days postpartum)

    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). No score/scale is used.

  6. Prolapse

    Time frame: At 9-12 months clinical follow-up

    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). No score/scale is used.

  7. Urinary incontinence

    Time frame: At 3, 6 and 9-12 months postpartum

    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.

    The ICIQ-UI-SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) score i derived from 3 of the 4 questions. The score ranges from 0 to 21 points. A higher score indicating a worse outcome.

  8. Pelvic symptoms

    Time frame: At baseline, 3, 6 and 9-12 months

    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. No score/scale is used.

  9. Number of clinical follow-ups

    Time frame: From delivery to 12 months postpartum

    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). No score/scale is used.

  10. EPDS

    Time frame: Baseline (1-1.5 months), 6 months and 9-12 months

    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.

    EPDS consists of 10 questions with each answer ranking from 0-3 points. Minimum 0 and maximum 30 points, with higher score meaning worse outcome. If total score is 10 or above it is considered as a potential depression requering treatment and follow-up is needed.

  11. Body Image

    Time frame: Questionnaire at 6 months and 9-12 months postpartum

    Body image score (FGSIS: Femal Genital Self-Image Scale) at 9-12 months for the intervention and the control group , and for all participants in the cohort.

    FGSIS consists of 7 items, where participants rate statements on a scale from 1 (strongly disagree) to 4 (strongly agree). The results are summed into a total score, with higher numbers indicating a more positive self-perception of the pelvic area.

  12. Sexual function

    Time frame: 6 and 9-12 months postpartum

    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. No score/scale is used.

Other outcomes

  1. Levator Ani Avulsion

    Time frame: At 9-12 months clinical follow-up

    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). LAD-score (Levator Ani Defiency Score) will be used til quantify the extent of damage. A minimum of 0 points and maximum of 18. A higher score indicates worse damage. A score of 6 or above is considered significant.

  2. Qualitative Component (Intervention group only)

    Time frame: Aprox. 2-8 weeks after concluded intervention

    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. No score/scale is used.

Study contacts

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

Hanna Jango, MD, PhD, Associate Professor

CONTACT

[email protected]

+4538681612

Iben O Hansen, MD

CONTACT

[email protected]

+4538689904

Sponsors and collaborators

Lead sponsor

Hanna Jangö

Other

Registry information

Official study 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

Acronym: ADAPT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 25, 2026
Registry last updated
Jul 24, 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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