Pelvic Floor Muscle Training During Pregnancy
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: PFMT, Standard care.
- Кому может быть актуально
- Состояния в реестре: Pelvic Floor, Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse. 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
PFMT During Pregnancy - Its Implementation and Effects on Pelvic Floor Disorders, Sexual Function and Obstetric Outcomes: a Hybrid Type 1 Design Randomised Controlled Trial
Обзор
The project seeks to investigate effectiveness of PFMT during pregnancy.
Подробное описание
First-time pregnant women will be recruited through visitations received from family doctors in all obstetrics departments of the Southern Denmark Region. Women will be randomised into two groups: ( Pelvic Floor Muscle Training) PFMT and a control group (standard care). The motivation-informed intervention will tackle both exercise engagement and exercise adherence. The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth. The data regarding pelvic floor disorders will be obtained at baseline, follow-ups once every trimester of pregnancy, as well as six weeks, three months, and six months postpartum with further follow-up after the study. The data regarding obstetric outcomes will be collected from electronic patient records. For evaluation of implementation process, data regarding motivation and training acceptability will be obtained via questionnaire at the baseline and at follow-up together with telephonically interviews during pregnancy and postpartum.
Вмешательства
- Поведенческое PFMT
The motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth. - Поведенческое Standard care
Standard care
Первичные конечные точки
- Urinary incontinence (UI) incidence at 3 months postpartum [Срок оценки: At 3 months follow-up after giving birth]
Вторичные конечные точки (12)
- Urinary incontinence at the 1st trimester of pregnancy [Срок оценки: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Urinary incontinence at the 2nd trimester of pregnancy [Срок оценки: At the follow-up at Gestational age 26 weeks and 0 days]
- Urinary incontinence incidence at the 3rd trimester of pregnancy [Срок оценки: At the follow-up at Gestational Age 36 weeks and 0 days]
- Urinary incontinence incidence at 6 weeks postpartum [Срок оценки: At the follow-up at 6 weeks postpartum]
- Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy [Срок оценки: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Anal incontinence (AI) in the 2nd trimester of pregnancy [Срок оценки: At the follow-up at Gestational Age 26 weeks and 0 days]
- Anal incontinence (AI) incidence in the 3rd trimester of pregnancy [Срок оценки: At the follow-up at Gestational Age 36 weeks and 0 days]
- Anal incontinence (AI) incidence at 6 weeks postpartum [Срок оценки: At the follow-up at 6 weeks postpartum]
- Anal incontinence (AI) incidence at 3 months postpartum [Срок оценки: At the follow-up at 3 months postpartum]
- Anal incontinence (AI) incidence at 6 months postpartum [Срок оценки: At the follow-up at 6 months postpartum]
- Sexual dysfunction incidence at inclusion, during the 1st trimester of pregnancy [Срок оценки: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy [Срок оценки: At the follow-up at Gestational Age 26weeks and 0 days]
Критерии участия
Критерии включения
- Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)
- Para 0 (no previous birth or pregnancy > 16 weeks of gestation)
- Understands, writes, and reads fluently in Danish or English
- Has a smart phone or computer/tablet to reach the training program
Критерии исключения
- Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)
- Active substance abuse
- Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)
- Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)
- Previous pregnancy of > 16 weeks of gestation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Дания · 1 центр
- Sygehus Sønderjylland — Aabenraa
Идентификаторы
NCT: NCT07104292 · SHS-KS-06-2025