Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05791630 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: NORWEL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2024 to Apr 1, 2025
    • Enrollment target: 20636 to 23650
    • Study sites: 1 to 10
    v3
  2. Minor Study completion date: Dec 31, 2027 to Dec 31, 2030v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05791630
Lead Sponsor Ostfold Hospital Trust
Conditions
(from sponsor)
Labor Dystocia, Labor Complication, Labor Onset and Length Abnormalities, Labor (Obstetrics)--Complications, Experience, Life, Progression, Cesarean Section Complications, Apgar; 4-7 at 1 Minute
Related terms Disease Progression, Dystocia, Obstetric Labor Complications
Enrollment 23,650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov