Clinical trial NCT05791630: The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Official title: The Norwegian World Health Organisation Labour Care Guide Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 23650
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter stepped wedge cluster randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Intrapartum cesarean section
timeFrame: 18 months
Secondary outcomes:
measure: Instrumental vaginal delivery
timeFrame: 18 months
measure: Perineal tears
timeFrame: 18 months
measure: Post partum hemorrhage
timeFrame: 18 months
measure: Estimated blood loss
timeFrame: 18 months
measure: Blood transfusion
timeFrame: 18 months
measure: The use of oxytocin
timeFrame: 18 months
measure: Dosage of oxytocin
timeFrame: 18 months
measure: Duration of oxytocin
timeFrame: 18 months
measure: initiation of oxytocin
timeFrame: 18 months
measure: Labour duration
timeFrame: 18 months
measure: The use of epidural analgesia
timeFrame: 18 months
measure: Duration of epidural analgesia
timeFrame: 18 months
measure: Initiation of epidural analgesia
timeFrame: 18 months
measure: The use of medical pain relief in labour
timeFrame: 18 months
measure: The use of non-medical pain relief in labour
timeFrame: 18 months
measure: Childbirth experience
timeFrame: 20 months
measure: Intermittent fetal monitoring
timeFrame: 18 months
measure: Continuous fetal monitoring
timeFrame: 18 months
measure: Neonatal Apgar scores
timeFrame: 18 months
measure: Neonatal metabolic acidosis
timeFrame: 18 months
measure: Admittance to Neonatal Intensive Care Unit
timeFrame: 18 months
measure: Duration of stay at neonatal Intensive Care Unit
timeFrame: 18 months
measure: Neonatal gender
timeFrame: 18 months
measure: Neonatal birth weight
timeFrame: 18 months
measure: Neonatal birth head circumference
timeFrame: 18 months
measure: Neonatal morbidity
timeFrame: 18 months
Other outcomes:
measure: Continuous support in labour
timeFrame: 18 months
measure: Birthing position
timeFrame: 18 months
measure: Fetal presentation
timeFrame: 18 months
measure: Perineal support
timeFrame: 18 months
measure: Skin-to-skin-contact
timeFrame: 18 months
measure: Breast feeding
timeFrame: 18 months
measure: The use of formula
timeFrame: 18 months
measure: Usability of the Labour Care Guide
timeFrame: 24 months
Locations:
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital, Ahus
state: Akershus
city: Drammen
country: Norway
facility: Vestre Viken Helseforetak, Drammen
state: Buskerud
city: Greåker
country: Norway
facility: Ostfold Hospital Trust
state: Ostfold
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
city: Tromsø
country: Norway
facility: University Hospital Northern Norway, Tromsø
state: Troms
city: Trondheim
country: Norway
facility: St.Olav University Hospital
state: Trøndelag
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestland
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Kristiansand
city: Oslo
country: Norway
facility: Oslo university hospital Rikshospitalet
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevål
Study officials:
affiliation: Ostfold Hospital Trust
name: Stine Bernitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: