The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
NORWEL
1 other identifier
interventional
23,650
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 4, 2025
April 1, 2025
1.8 years
January 17, 2023
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Intrapartum cesarean section
the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
18 months
Secondary Outcomes (26)
Instrumental vaginal delivery
18 months
Perineal tears
18 months
Post partum hemorrhage
18 months
Estimated blood loss
18 months
Blood transfusion
18 months
- +21 more secondary outcomes
Other Outcomes (8)
Continuous support in labour
18 months
Birthing position
18 months
Fetal presentation
18 months
- +5 more other outcomes
Study Arms (2)
WHO partograph
NO INTERVENTIONall study sites use the WHO partograph as standard care in the first step of the trial
WHO labour care guide
EXPERIMENTALAll study sites will cross over to the intervention according to randomization and use the LCG for assessing labour progression and wellbeing in labour
Interventions
The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour
Eligibility Criteria
You may qualify if:
- Women in active labour
- Labour and delivery at study sites
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Akershus University Hospital, Ahus
Nordbyhagen, Akershus, 1478, Norway
Vestre Viken Helseforetak, Drammen
Drammen, Buskerud, 3004, Norway
Sørlandet Hospital Kristiansand
Kristiansand, Kristiansand, 4615, Norway
Oslo university hospital Rikshospitalet
Oslo, Oslo County, 0372, Norway
Oslo University Hospital Ullevål
Oslo, Oslo County, 0450, Norway
Stavanger University Hospital
Stavanger, Rogaland, 4019, Norway
University Hospital Northern Norway, Tromsø
Tromsø, Troms, 9038, Norway
St.Olav University Hospital
Trondheim, Trøndelag, 7006, Norway
Haukeland University Hospital
Bergen, Vestland, 5009, Norway
Ostfold Hospital Trust
Greåker, Østfold fylke, 1714, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stine Bernitz, PhD
Ostfold Hospital Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor/researcher
Study Record Dates
First Submitted
January 17, 2023
First Posted
March 30, 2023
Study Start
April 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- from onset of trial until five years after the trial has ended
- Access Criteria
- if the purpose is stated and acceptable and presented by scientific personnel
Will be shared according to demand and aim