Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID05791630

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women in active labour
  • Labour and delivery at study sites
  • Female
  • Age 18 years or older
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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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