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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hanna Jango, MD, PhD, Associate Professor
- Numéro de téléphone: +4538681612
- E-mail: hanna.margareta.jangoe@regionh.dk
Sauvegarde des contacts de l'étude
- Nom: Iben O Hansen, MD
- Numéro de téléphone: +4538689904
- E-mail: iben.onsberg.hansen@regionh.dk
Lieux d'étude
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Capital Region
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Herlev, Capital Region, Danemark, 2730
- Department of Gynecology and Obstetrics at Herlev Hospital
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Contact:
- Hanna Jango, MD, PhD, Associate Professor
- Numéro de téléphone: +4538681612
- E-mail: hanna.margareta.jangoe@regionh.dk
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Contact:
- Iben O Hansen, MD
- Numéro de téléphone: +4538689904
- E-mail: iben.onsberg.hansen@regionh.dk
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Sous-enquêteur:
- Iben O Hansen, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune 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.
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ICIQ-B Quality of Life Domain
Délai: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
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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
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Symptoms of Anal Incontinence (Cohort)
Délai: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ICIQ-B (total) score
Délai: From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
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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
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Anal Incontinence symptoms
Délai: From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
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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.
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From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
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EAUS
Délai: At 9-12 months clinical follow-up
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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.
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At 9-12 months clinical follow-up
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Wound dehiscence
Délai: At early clinical follow-up (8-14 days postpartum)
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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.
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At early clinical follow-up (8-14 days postpartum)
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Infection
Délai: At early clinical follow-up (8-14 days postpartum)
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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.
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At early clinical follow-up (8-14 days postpartum)
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Prolapse
Délai: At 9-12 months clinical follow-up
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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.
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At 9-12 months clinical follow-up
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Urinary incontinence
Délai: At 3, 6 and 9-12 months postpartum
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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
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Pelvic symptoms
Délai: At baseline, 3, 6 and 9-12 months
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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.
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At baseline, 3, 6 and 9-12 months
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Number of clinical follow-ups
Délai: From delivery to 12 months postpartum
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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.
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From delivery to 12 months postpartum
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EPDS
Délai: Baseline (1-1.5 months), 6 months and 9-12 months
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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
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Body Image
Délai: Questionnaire at 6 months and 9-12 months postpartum
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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
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Sexual function
Délai: 6 and 9-12 months postpartum
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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.
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6 and 9-12 months postpartum
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Levator Ani Avulsion
Délai: At 9-12 months clinical follow-up
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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.
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At 9-12 months clinical follow-up
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Qualitative Component (Intervention group only)
Délai: Aprox. 2-8 weeks after concluded intervention
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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.
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Aprox. 2-8 weeks after concluded intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hanna Jango, MD, PhD, Associate Professor, Department of Gynecology and Obstetrics at Herlev Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-26012116
Plan pour les données individuelles des participants (IPD)
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