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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hanna Jango, MD, PhD, Associate Professor
- Номер телефона: +4538681612
- Электронная почта: hanna.margareta.jangoe@regionh.dk
Учебное резервное копирование контактов
- Имя: Iben O Hansen, MD
- Номер телефона: +4538689904
- Электронная почта: iben.onsberg.hansen@regionh.dk
Места учебы
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Capital Region
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Herlev, Capital Region, Дания, 2730
- Department of Gynecology and Obstetrics at Herlev Hospital
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Контакт:
- Hanna Jango, MD, PhD, Associate Professor
- Номер телефона: +4538681612
- Электронная почта: hanna.margareta.jangoe@regionh.dk
-
Контакт:
- Iben O Hansen, MD
- Номер телефона: +4538689904
- Электронная почта: iben.onsberg.hansen@regionh.dk
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Младший исследователь:
- Iben O Hansen, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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ICIQ-B Quality of Life Domain
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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ICIQ-B (total) score
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Levator Ani Avulsion
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Hanna Jango, MD, PhD, Associate Professor, Department of Gynecology and Obstetrics at Herlev Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- H-26012116
Планирование данных отдельных участников (IPD)
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