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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hanna Jango, MD, PhD, Associate Professor
- Número de teléfono: +4538681612
- Correo electrónico: hanna.margareta.jangoe@regionh.dk
Copia de seguridad de contactos de estudio
- Nombre: Iben O Hansen, MD
- Número de teléfono: +4538689904
- Correo electrónico: iben.onsberg.hansen@regionh.dk
Ubicaciones de estudio
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Capital Region
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Herlev, Capital Region, Dinamarca, 2730
- Department of Gynecology and Obstetrics at Herlev Hospital
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Contacto:
- Hanna Jango, MD, PhD, Associate Professor
- Número de teléfono: +4538681612
- Correo electrónico: hanna.margareta.jangoe@regionh.dk
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Contacto:
- Iben O Hansen, MD
- Número de teléfono: +4538689904
- Correo electrónico: iben.onsberg.hansen@regionh.dk
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Sub-Investigador:
- Iben O Hansen, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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ICIQ-B Quality of Life Domain
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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ICIQ-B (total) score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Levator Ani Avulsion
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hanna Jango, MD, PhD, Associate Professor, Department of Gynecology and Obstetrics at Herlev Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-26012116
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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