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

NCT05791630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23650

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Labor Dystocia
  • Labor Complication
  • Labor Onset and Length Abnormalities
  • Labor (Obstetrics)--Complications
  • Experience, Life
  • Progression
  • Cesarean Section Complications
  • Apgar; 4-7 at 1 Minute

Interventions

OTHER

the labour care guide (LCG)

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

Sponsors & Collaborators

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Stine Bernitz, PhD · Ostfold Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05791630 on ClinicalTrials.gov