NCT05791630 The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
| NCT ID | NCT05791630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ostfold Hospital Trust |
| Condition | Labor Dystocia |
| Study Type | INTERVENTIONAL |
| Enrollment | 23,650 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23,650 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Women in active labour * Labour and delivery at study sites Exclusion Criteria: * None
Contact & Investigator
Stine Bernitz, PhD
PRINCIPAL INVESTIGATOR
Ostfold Hospital Trust
Frequently Asked Questions
Who can join the NCT05791630 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Labor Dystocia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05791630 currently recruiting?
Yes, NCT05791630 is actively recruiting participants. Contact the research team at stine.bernitz@oslomet.no for enrollment information.
Where is the NCT05791630 trial being conducted?
This trial is being conducted at Nordbyhagen, Norway, Drammen, Norway, Kristiansand, Norway, Oslo, Norway and 6 additional locations.
Who is sponsoring the NCT05791630 clinical trial?
NCT05791630 is sponsored by Ostfold Hospital Trust. The principal investigator is Stine Bernitz, PhD at Ostfold Hospital Trust. The trial plans to enroll 23,650 participants.