RecruitingNot ApplicableNCT05791630

The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)

The Norwegian World Health Organisation Labour Care Guide Trial


Sponsor

Ostfold Hospital Trust

Enrollment

23,650 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a large, pragmatic trial testing whether using the World Health Organization's Labour Care Guide (LCG) — a new partograph (labor monitoring tool) — improves outcomes for women and their babies during childbirth compared to the standard labor monitoring tool used in Norway. The LCG was developed by the WHO to move away from a one-size-fits-all approach to labor progress and avoid unnecessary interventions, such as emergency C-sections triggered by labor being labelled 'too slow' under older criteria. The study is open to all women who are in active labor and delivering at one of the study hospital sites. There are no exclusion criteria — all women in active labor at participating hospitals can be enrolled. The study is a cluster randomized trial, meaning entire maternity units are randomly assigned to use either the LCG or the existing standard partograph during the study period. Researchers will track rates of C-sections, labor interventions, and maternal and newborn outcomes. This research is highly significant because the way labor is monitored and managed directly affects whether women undergo unnecessary (and risky) interventions versus receiving timely care when truly needed — with profound implications for maternal and newborn health at a population level.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERthe labour care guide (LCG)

The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour


Locations(10)

Akershus University Hospital, Ahus

Nordbyhagen, Akershus, Norway

Vestre Viken Helseforetak, Drammen

Drammen, Buskerud, Norway

Sørlandet Hospital Kristiansand

Kristiansand, Kristiansand, Norway

Oslo university hospital Rikshospitalet

Oslo, Oslo, Norway

Oslo University Hospital Ullevål

Oslo, Oslo, Norway

Stavanger University Hospital

Stavanger, Rogaland, Norway

University Hospital Northern Norway, Tromsø

Tromsø, Troms, Norway

St.Olav University Hospital

Trondheim, Trøndelag, Norway

Haukeland University Hospital

Bergen, Vestland, Norway

Ostfold Hospital Trust

Greåker, Østfold fylke, Norway

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NCT05791630


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