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KVINNEHELSE-Kvinners helse og kjønnsperspektiver

The Norwegian WHO Labour Care Guide trial: a stepped wedge multicentre cluster randomised trial for safety and wellbeing in labour

Alternative title: Den norske WHO Labour Care Guide studien: en multisenter trappetrinn kluster randomisert studie for sikkerhet og velvære i fødsel

Awarded: NOK 4.9 mill.

Project Number:

343448

Application Type:

Project Period:

2023 - 2027

Location:

The Norwegian WHO LCG Trial is an upcoming project that aims to uncover the impact of the LCG on labor interventions, maternal and newborn outcomes, and the childbirth experience, all tailored to Norway's unique healthcare system. The trial is important, to make sure that the LCG is the right tool to roll out and to be used in high-income settings. It is important to ensure that it is supported by robust evidence, and this trial will be the cornerstone of our decision-making process. The trial will reveal how the LCG can improve labor and delivery care with better decision-making, fewer complications, and an overall enhanced birthing experience, considering the psychological aspect of childbirth, making sure women feel empowered and informed throughout the process. The trial is a journey toward safer, more personalized, and more empowering births. In the fall of 2024, the research group is working on preparations for the study. Information materials, collaboration agreements, and data protection impact assessments are being developed. The project is currently being piloted at Bodø Hospital, having started in September and continuing until November 2024.

Appropriate and timely care during birth is critical to the survival and health of women and babies. A partograph is designed to record observations during birth and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. The choice of partograph directly impacts intervention rates. If midwives and obstetricians are alerted too late, unwanted birth outcomes may be the consequence. If midwives and obstetricians are alerted too early, unnecessary interventions and unwanted complications may follow. In 2020 the WHO presented the Labour Care Guide (LCG) as the recommended tool for monitoring birth and assessing progression and to be used in all settings globally and is rolled out internationally. The usability and feasibility of the LCG has been tested in health facilities in South America, Asia, and Africa, but has not been evaluated in high-income settings. Possible advantages in Norway and countries with similar health-, social-, and economic systems are yet unknown and need to be explored before implement a new progression tool in labour care. Implementing the LCG as a new guideline for monitoring birth is a comprehensive operation for economy, institutions, systems and individuals. Such an implementation should be evidence based. Hence, this trial is crucial to form the foundation of knowledge for the decision of an eventual implementation of the LCG. The NOR WHO LCG Trial will be conducted through an established network working towards increasing standards of care in Norway. The robust research environment with broad experience in conducting large randomized controlled trials will secure a thorough implementation of the trial. The guideline for birth care by the Norwegian Association of Obstetrics and Gynecology will lean on the evidence provided by this trial to tailor the LCG to meet the needs in Norway prior to a national enrollment.

Funding scheme:

KVINNEHELSE-Kvinners helse og kjønnsperspektiver

Funding Sources