The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
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: the labour care guide (LCG).
- Кому может быть актуально
- Состояния в реестре: Labor Dystocia, Labor Complication, Labor Onset and Length Abnormalities, Labor (Obstetrics)--Complications. 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
- Норвегия
- 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
The Norwegian World Health Organisation Labour Care Guide Trial
Обзор
Appropriate and timely care during birth is critical to the survival and health of women and their babies. In 2020, the World Health Organization (WHO) presented the Labour Care Guide (LCG) as the new recommended tool for monitoring birth and assessing progression, replacing the WHO partograph. This evidence-based guide was designed to ensure improved quality and safety of care, and to avoid unnecessary interventions during birth. The LCG was developed to be used in all settings globally, but it has only been tested in health facilities in South America, Asia and Africa, while it has not been tested in high-income settings. Implementing a new guideline for monitoring birth is a comprehensive operation that will affect both the national economy, health systems, and individual patients; therefore, further research on the possible advantages is needed before national enrolment. Hence, the trial proposed in this application is crucial to form the required foundation of knowledge. The trial will be conducted in labour wards at ten hospitals, covering all health regions in Norway, and the established Norwegian Research Network for Clinical Studies in Obstetrics (NORBIRTH), with dedicated local principal investigators, will provide a robust research environment. This trial will test the effect of the LCG. Results from this trial will provide knowledge needed to determine a future implementation of the LCG in Norway.
Подробное описание
A large robust trial investigating the effect of the LCG is needed to establish a foundation of knowledge on which the decision of implementing the LCG on a national level should be based. The Norwegian WHO LCG trial addresses the WHO research priority question: "What is the effect of the LCG on processes of care, health, well-being and outcomes during labour and childbirth?". The trial will have a special focus on intrapartum caesarean section rates and experience of labour.
The overall aim of the trial is to test the LCG in an unbiased population in a Norwegian setting. The project will conduct a nationwide randomized controlled trial (RCT) to test the effect on labour interventions and maternal and neonatal outcomes compared to the previous WHO partograph. The Norwegian WHO LCG trial will be conducted through three work packages: WP1 consists of a feasibility study to develop an electronic version of the LCG, and will test its validity and usability prior to the planned RCT. WP2 consists of a stepped wedge RCT to assess the effect of the LCG on labour interventions and maternal and neonatal outcomes. WP3 consists of a survey to investigate patient reported outcome through the childbirth experience questionnaire (CEQ).
This is a stepped wedge multicenter cluster randomised non-inferiority trial, to be conducted within the nationwide NORBIRTH network for clinical obstetric research. The hospitals will act as clusters and the women as individual participants.
During the trial period all hospitals will use the WHO partograph and the LCG according to the trial protocol for all women with a planned vaginal delivery, these women constitute the trial population. Women who want to opt out will not be included in the analyses. Each hospital has established local research groups which are dedicated to implement the project. The included hospitals will consent to adhere to the protocol in the trial period and state that they have the capacity to participate both logistically and practically. Local coordinators will be appointed with the responsibility of monitoring the trial and secure a thorough documentation according to the protocol.
Вмешательства
- Другое the labour care guide (LCG)
The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour
Первичные конечные точки
- Intrapartum cesarean section [Срок оценки: 18 months]
Вторичные конечные точки (12)
- Instrumental vaginal delivery [Срок оценки: 18 months]
- Perineal tears [Срок оценки: 18 months]
- Post partum hemorrhage [Срок оценки: 18 months]
- Estimated blood loss [Срок оценки: 18 months]
- Blood transfusion [Срок оценки: 18 months]
- The use of oxytocin [Срок оценки: 18 months]
- Dosage of oxytocin [Срок оценки: 18 months]
- Duration of oxytocin [Срок оценки: 18 months]
- initiation of oxytocin [Срок оценки: 18 months]
- Labour duration [Срок оценки: 18 months]
- The use of epidural analgesia [Срок оценки: 18 months]
- Duration of epidural analgesia [Срок оценки: 18 months]
Критерии участия
Критерии включения
- Women in active labour
- Labour and delivery at study sites
Критерии исключения
- None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Норвегия · 10 центров
- Akershus University Hospital, Ahus — Nordbyhagen
- Vestre Viken Helseforetak, Drammen — Drammen
- Sørlandet Hospital Kristiansand — Kristiansand
- Oslo university hospital Rikshospitalet — Oslo
- Oslo University Hospital Ullevål — Oslo
- Stavanger University Hospital — Stavanger
- University Hospital Northern Norway, Tromsø — Tromsø
- St.Olav University Hospital — Trondheim
- … и ещё 2 центра
Идентификаторы
NCT: NCT05791630 · 2023084