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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Norwegian World Health Organisation Labour Care Guide Trial

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

Intervention / Treatment
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* Other: the labour care guide (LCG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in active labour Labour and delivery at study sites Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multicenter stepped wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: WHO partograph<br>all study sites use the WHO partograph as standard care in the first step of the trial | |
| Experimental: WHO labour care guide<br>All study sites will cross over to the intervention according to randomization and use the LCG for assessing labour progression and wellbeing in labour | Other: the labour care guide (LCG)<br>* The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapartum cesarean section | the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental vaginal delivery | The rate of instrumental vaginal delivery, presented in numbers and percentages | 18 months | 
| Perineal tears | Perineal tears will be presented in numbers and percentages | 18 months | 
| Post partum hemorrhage | Post partum hemorrhage will be presented in numbers and percentages. | 18 months | 
| Estimated blood loss | Estimated blood loss will be presented in ml of blood loss | 18 months | 
| Blood transfusion | The need for blood transfusion will be presented in numbers and percentages | 18 months | 
| The use of oxytocin | The use of oxytocin will be presented in numbers and percentages | 18 months | 
| Dosage of oxytocin | The dosages of oxytocin will be presented in milli units (m/U) | 18 months | 
| Duration of oxytocin | The duration of oxytocin will be presented in hours and minutes | 18 months | 
| initiation of oxytocin | Initiation of oxytocin will be presented according to cervical dilatation in centimetres | 18 months | 
| Labour duration | Labour duration will be presented in hours and minutes | 18 months | 
| The use of epidural analgesia | The use of epidural analgesia will be presented in numbers and percentages | 18 months | 
| Duration of epidural analgesia | Duration of epidural analgesia will be presented hours and minutes | 18 months | 
| Initiation of epidural analgesia | The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres | 18 months | 
| The use of medical pain relief in labour | The use of medical pain relief will be presented in numbers and percentages. | 18 months | 
| The use of non-medical pain relief in labour | The use of non-medical pain relief will be presented in numbers and percentages. | 18 months | 
| Childbirth experience | Childbirth experience measured by the childbirth experience questionnaire, CEQ presented in total and mean scores according to the four domains in the CEQ questionnaire | 20 months | 
| Intermittent fetal monitoring | The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages | 18 months | 
| Continuous fetal monitoring | The use of continuous fetal monitoring will be presented in numbers and percentages | 18 months | 
| Neonatal Apgar scores | Apgar scores 1/5/10 minutes post partum presented in values of 0-10 | 18 months | 
| Neonatal metabolic acidosis | Metabolic acidosis will be presented in numbers and percentages | 18 months | 
| Admittance to Neonatal Intensive Care Unit | Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages | 18 months | 
| Duration of stay at neonatal Intensive Care Unit | Duration of stay at neonatal Intensive Care Unit will be presented days | 18 months | 
| Neonatal gender | Neonatal gender will be presented by numbers and percentages | 18 months | 
| Neonatal birth weight | Neonatal birth weight will be presented in kilograms | 18 months | 
| Neonatal birth head circumference | Neonatal head circumference will be presented in centimetres | 18 months | 
| Neonatal morbidity | Neonatal morbidity will be presented in numbers and percentages. | 18 months |