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

2026년 7월 23일 업데이트: Hanna Jangö

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

110

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 덴마크
    • Capital Region
      • Herlev, Capital Region, 덴마크, 2730
        • Department of Gynecology and Obstetrics at Herlev Hospital
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Iben O Hansen, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
활성 비교기: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
ICIQ-B Quality of Life Domain
기간: 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.
From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
Symptoms of Anal Incontinence (Cohort)
기간: 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.
From 8-14 days and at 1-1.5, 3, 6 and 9-12 months

2차 결과 측정

결과 측정
측정값 설명
기간
ICIQ-B (total) score
기간: 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.
From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
Anal Incontinence symptoms
기간: 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.
From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
EAUS
기간: 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.
At 9-12 months clinical follow-up
Wound dehiscence
기간: 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.
At early clinical follow-up (8-14 days postpartum)
Infection
기간: 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.
At early clinical follow-up (8-14 days postpartum)
Prolapse
기간: 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.
At 9-12 months clinical follow-up
Urinary incontinence
기간: 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.
At 3, 6 and 9-12 months postpartum
Pelvic symptoms
기간: 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.
At baseline, 3, 6 and 9-12 months
Number of clinical follow-ups
기간: 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.
From delivery to 12 months postpartum
EPDS
기간: 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.
Baseline (1-1.5 months), 6 months and 9-12 months
Body Image
기간: 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.
Questionnaire at 6 months and 9-12 months postpartum
Sexual function
기간: 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.
6 and 9-12 months postpartum

기타 결과 측정

결과 측정
측정값 설명
기간
Levator Ani Avulsion
기간: 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.
At 9-12 months clinical follow-up
Qualitative Component (Intervention group only)
기간: 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.
Aprox. 2-8 weeks after concluded intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hanna Jangö

수사관

  • 수석 연구원: Hanna Jango, MD, PhD, Associate Professor, Department of Gynecology and Obstetrics at Herlev Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2029년 8월 31일

연구 완료 (추정된)

2029년 8월 31일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 18일

처음 게시됨 (실제)

2026년 6월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 23일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • H-26012116

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

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아니

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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