Actively Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial
Led by Ostfold Hospital Trust · Updated on 2025-04-04
23650
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Labour Care Guide (LCG), a new tool designed by the World Health Organization to improve the quality and safety of care during childbirth by replacing the previous WHO partograph. This trial aims to test the LCG's effect on labor interventions and maternal and neonatal outcomes in Norway, focusing especially on cesarean section rates and women's experience of labor. The study is important because the LCG has not yet been tested in high-income settings like Norway, and the results will guide possible national implementation. The trial uses a stepped wedge multicenter cluster randomized design involving ten hospitals across Norway. Initially, all sites will use the WHO partograph as standard care, then switch to using the LCG according to a randomized schedule. The study consists of three parts: developing and testing an electronic version of the LCG, conducting the randomized trial to compare outcomes using the LCG versus the partograph, and surveying women about their childbirth experience using a questionnaire. Women with planned vaginal deliveries will be included unless they opt out. Participants will be monitored throughout labor using either the WHO partograph or the LCG depending on the hospital's phase in the trial. Researchers will collect data on labor interventions, maternal health, neonatal outcomes, and childbirth experience. Outcomes measured include cesarean section rates, instrumental vaginal delivery, perineal tears, postpartum hemorrhage, oxytocin use, pain relief methods, fetal monitoring, neonatal Apgar scores, and neonatal intensive care admissions. The trial will last 18 to 20 months, with thorough documentation and local coordinators ensuring adherence to the protocol.
CONDITIONS
Brief Title
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women in active labour
- Labour and delivery at study sites
- Female
- Age 18 years or older
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Labour duration (hours)
Participants receive care during labour, monitored either with the WHO partograph or the labour care guide (LCG) according to randomization and trial phase.
1 visit during labour (in-person)
Duration - Up to 20 months
Participants are followed to assess maternal and neonatal outcomes as well as childbirth experience.
1 follow-up visit and survey after delivery
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
Research Team
S
Stine Bernitz, PhD
R
Rebecka Dalbye, PhD
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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