Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05791630

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

Led by Ostfold Hospital Trust · Updated on 2025-04-04

23650

Participants Needed

10

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women in active labour
  • Labour and delivery at study sites
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Akershus University Hospital, Ahus

Nordbyhagen, Akershus, Norway, 1478

Actively Recruiting

2

Vestre Viken Helseforetak, Drammen

Drammen, Buskerud, Norway, 3004

Actively Recruiting

3

Sørlandet Hospital Kristiansand

Kristiansand, Kristiansand, Norway, 4615

Actively Recruiting

4

Oslo university hospital Rikshospitalet

Oslo, Oslo, Norway, 0372

Actively Recruiting

5

Oslo University Hospital Ullevål

Oslo, Oslo, Norway, 0450

Actively Recruiting

6

Stavanger University Hospital

Stavanger, Rogaland, Norway, 4019

Actively Recruiting

7

University Hospital Northern Norway, Tromsø

Tromsø, Troms, Norway, 9038

Actively Recruiting

8

St.Olav University Hospital

Trondheim, Trøndelag, Norway, 7006

Actively Recruiting

9

Haukeland University Hospital

Bergen, Vestland, Norway, 5009

Actively Recruiting

10

Ostfold Hospital Trust

Greåker, Østfold fylke, Norway, 1714

Not Yet Recruiting

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Research Team

S

Stine Bernitz, PhD

CONTACT

R

Rebecka Dalbye, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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