Идёт набор NCT06026423

Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

— Наблюдательное Dehiscence Wound Secondary Perineal Tear Episiotomy; Dehiscence

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: Clinical examination and pictures, Questionnaire.
Кому может быть актуально: Состояния в реестре: Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing

Обзор

The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing. Participants will be asked to do * A gynecological examination at one month after birth and 9-12 months after birth. * Have a picture taken of the healing process * Answer a questionnaire at one month, three months, and 9-12 months after birth

Подробное описание

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence.

The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management.

All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.

Вмешательства

Другое Clinical examination and pictures
A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.
Другое Questionnaire
The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.

Первичные конечные точки

Body image [Срок оценки: 9-12 months]

Вторичные конечные точки (12)

Wound healing [Срок оценки: One month]
Infection rate [Срок оценки: One month]
Resuming sexual intercourse [Срок оценки: One month, three months, and 9-12 months]
Dyspareunia [Срок оценки: One month, three months, and 9-12months]
Woman´s satisfaction with the aesthetic results of the perineal wound [Срок оценки: One month, three months, and 9-12 months]
Affected breastfeeding [Срок оценки: One month, three months, and 9-12 months]
Re-admission [Срок оценки: Within one month]
Prolapse [Срок оценки: One month, three months, and 9-12 months]
Urinary incontinence [Срок оценки: One month, three months, and 9-12 months]
Fecal incontinence [Срок оценки: One month, three months, and 9-12 months]
Psychological well-being (maternal anxiety or depression) [Срок оценки: Three months, and 9-12 months]
Pain intensity [Срок оценки: One month, three months, and 9-12 months]

Критерии участия

Критерии включения

Women with a vaginal delivery who have had a primary repair of a second-degree perineal tear or episiotomy
At least 18 years old
Able to understand, read and speak Danish or English
Able to give informed consent