Набор скоро начнётся NCT07667660

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

Без фазы С лечением Obstetric Anal Sphincter Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Group Session.
Кому может быть актуально: Состояния в реестре: Obstetric Anal Sphincter Injury. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

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.

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 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.

Вмешательства

Другое 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.

Первичные конечные точки

ICIQ-B Quality of Life Domain [Срок оценки: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum]
Symptoms of Anal Incontinence (Cohort) [Срок оценки: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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