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

NCT ID: NCT05791630

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-12-31

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.

Detailed Description

A large robust trial investigating the effect of the LCG is needed to establish a foundation of knowledge on which the decision of implementing the LCG on a national level should be based. The Norwegian WHO LCG trial addresses the WHO research priority question: "What is the effect of the LCG on processes of care, health, well-being and outcomes during labour and childbirth?". The trial will have a special focus on intrapartum caesarean section rates and experience of labour.

The overall aim of the trial is to test the LCG in an unbiased population in a Norwegian setting. The project will conduct a nationwide randomized controlled trial (RCT) to test the effect on labour interventions and maternal and neonatal outcomes compared to the previous WHO partograph. The Norwegian WHO LCG trial will be conducted through three work packages: WP1 consists of a feasibility study to develop an electronic version of the LCG, and will test its validity and usability prior to the planned RCT. WP2 consists of a stepped wedge RCT to assess the effect of the LCG on labour interventions and maternal and neonatal outcomes. WP3 consists of a survey to investigate patient reported outcome through the childbirth experience questionnaire (CEQ).

This is a stepped wedge multicenter cluster randomised non-inferiority trial, to be conducted within the nationwide NORBIRTH network for clinical obstetric research. The hospitals will act as clusters and the women as individual participants.

During the trial period all hospitals will use the WHO partograph and the LCG according to the trial protocol for all women with a planned vaginal delivery, these women constitute the trial population. Women who want to opt out will not be included in the analyses. Each hospital has established local research groups which are dedicated to implement the project. The included hospitals will consent to adhere to the protocol in the trial period and state that they have the capacity to participate both logistically and practically. Local coordinators will be appointed with the responsibility of monitoring the trial and secure a thorough documentation according to the protocol.

Conditions

Labor Dystocia; Labor Complication; Labor Onset and Length Abnormalities; Labor (Obstetrics)--Complications; Experience, Life; Progression; Cesarean Section Complications; Apgar; 4-7 at 1 Minute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WHO partograph

all study sites use the WHO partograph as standard care in the first step of the trial

Group Type: NO_INTERVENTION

No interventions assigned to this group

WHO labour care guide

All study sites will cross over to the intervention according to randomization and use the LCG for assessing labour progression and wellbeing in labour

Group Type: EXPERIMENTAL

the labour care guide (LCG)

Intervention Type: OTHER

The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour

Interventions

the labour care guide (LCG)

The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women in active labour
• Labour and delivery at study sites

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Stine Bernitz

Professor/researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stine Bernitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital Trust

Locations

Akershus University Hospital, Ahus

Nordbyhagen, Akershus, Norway

Site Status: RECRUITING

Vestre Viken Helseforetak, Drammen

Drammen, Buskerud, Norway

Site Status: RECRUITING

Sørlandet Hospital Kristiansand

Kristiansand, Kristiansand, Norway

Site Status: RECRUITING

Oslo university hospital Rikshospitalet

Oslo, Oslo County, Norway

Site Status: RECRUITING

Oslo University Hospital Ullevål

Oslo, Oslo County, Norway

Site Status: RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, Norway

Site Status: RECRUITING

University Hospital Northern Norway, Tromsø

Tromsø, Troms, Norway

Site Status: RECRUITING

St.Olav University Hospital

Trondheim, Trøndelag, Norway

Site Status: RECRUITING

Haukeland University Hospital

Bergen, Vestland, Norway

Site Status: RECRUITING

Ostfold Hospital Trust

Greåker, Østfold fylke, Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Stine Bernitz, PhD

Role: CONTACT

stine.bernitz@oslomet.no

+4790944715

Rebecka Dalbye, PhD

Role: CONTACT

rebecka.dalbye@oslomet.no

+4745247873

Facility Contacts

Camilla M Haavaldsen

Role: primary

marit.camilla.haavaldsen@ahus.no

+4767960000

Shruti Sharma, ph.d.

Role: primary

Shruti.Sharma@vestreviken.no

+4732803000

Janne Rossen, ph.d.

Role: primary

janne.rossen@sshf.no

+4798464129

Trond F Michelsen, ph.d.

Role: primary

trmi1@ous-hf.no

+4740042502

Anne F Jacobsen, ph.d.

Role: primary

UXAFJA@ous-hf.no

+4792814298

Ragnar K Sande, ph.d.

Role: primary

ragnar.kvie.sande@sus.no

+4797977379

Elsa Lindtjørn, MSC

Role: backup

elsa@lindtjorn.no

+4791693929

Åse Torunn Pettersen, MSC

Role: primary

aase.torunn.revholt.pettersen@unn.no

+4791332077

Elisabeth Magnussen, ph.d.

Role: primary

elisabeth.magnussen@stolav.no

+4792205929

Jørg Kessler, ph.d.

Role: primary

jorg.kessler@helse-bergen.no

+4797709603

Rebecka Dalbye, PhD

Role: primary

rebda@oslomet.no

+4745247873

Waleed Ghanima, PhD

Role: backup

waleed.ghanima@so-hf.no

+4741303440

Other Identifiers

2023084

Identifier Type: -

Identifier Source: org_study_id