The Norwegian World Health Organisation Labour Care Guide Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 23,650
- 试验地点
- 20
- 主要终点
- Intrapartum cesarean section
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in active labour
- •Labour and delivery at study sites
排除标准
- 未提供
结局指标
主要结局
Intrapartum cesarean section
时间窗: 18 months
the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
次要结局
- Neonatal Apgar scores(18 months)
- Duration of stay at neonatal Intensive Care Unit(18 months)
- Estimated blood loss(18 months)
- Duration of oxytocin(18 months)
- Labour duration(18 months)
- Duration of epidural analgesia(18 months)
- The use of oxytocin(18 months)
- Dosage of oxytocin(18 months)
- Post partum hemorrhage(18 months)
- Initiation of epidural analgesia(18 months)
- Instrumental vaginal delivery(18 months)
- Perineal tears(18 months)
- The use of epidural analgesia(18 months)
- Blood transfusion(18 months)
- The use of non-medical pain relief in labour(18 months)
- Neonatal morbidity(18 months)
- initiation of oxytocin(18 months)
- The use of medical pain relief in labour(18 months)
- Childbirth experience(20 months)
- Intermittent fetal monitoring(18 months)
- Continuous fetal monitoring(18 months)
- Admittance to Neonatal Intensive Care Unit(18 months)
- Neonatal birth weight(18 months)
- Neonatal birth head circumference(18 months)
- Neonatal metabolic acidosis(18 months)
- Neonatal gender(18 months)
研究者
Stine Bernitz
Professor/researcher
Ostfold Hospital Trust