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

2026年7月23日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

110

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • デンマーク
    • Capital Region
      • Herlev、Capital Region、デンマーク、2730
        • Department of Gynecology and Obstetrics at Herlev Hospital
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Iben O Hansen, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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.
アクティブコンパレータ：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
ICIQ-B Quality of Life Domain
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
ICIQ-B (total) score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Levator Ani Avulsion
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hanna Jangö

捜査官

  • 主任研究者：Hanna Jango, MD, PhD, Associate Professor、Department of Gynecology and Obstetrics at Herlev Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2029年8月31日

研究の完了 (推定)

2029年8月31日

試験登録日

最初に提出

2026年6月18日

QC基準を満たした最初の提出物

2026年6月18日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24日

QC基準を満たした最後の更新が送信されました

2026年7月23日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • H-26012116

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いいえ

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