The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
- Conditions
- Labor Onset and Length AbnormalitiesLabor (Obstetrics)--ComplicationsLabor DystociaApgar; 4-7 at 1 MinuteExperience, LifeProgressionCesarean Section ComplicationsLabor Complication
- Interventions
- Other: the labour care guide (LCG)
- Registration Number
- NCT05791630
- Lead Sponsor
- Ostfold Hospital Trust
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 23650
- Women in active labour
- Labour and delivery at study sites
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description WHO labour care guide the labour care guide (LCG) All study sites will cross over to the intervention according to randomization and use the LCG for assessing labour progression and wellbeing in labour
- Primary Outcome Measures
Name Time Method Intrapartum cesarean section 18 months the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
- Secondary Outcome Measures
Name Time Method Neonatal Apgar scores 18 months Apgar scores 1/5/10 minutes post partum presented in values of 0-10
Duration of stay at neonatal Intensive Care Unit 18 months Duration of stay at neonatal Intensive Care Unit will be presented days
Estimated blood loss 18 months Estimated blood loss will be presented in ml of blood loss
Duration of oxytocin 18 months The duration of oxytocin will be presented in hours and minutes
Labour duration 18 months Labour duration will be presented in hours and minutes
Duration of epidural analgesia 18 months Duration of epidural analgesia will be presented hours and minutes
The use of oxytocin 18 months The use of oxytocin will be presented in numbers and percentages
Dosage of oxytocin 18 months The dosages of oxytocin will be presented in milli units (m/U)
Post partum hemorrhage 18 months Post partum hemorrhage will be presented in numbers and percentages.
Initiation of epidural analgesia 18 months The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres
Instrumental vaginal delivery 18 months The rate of instrumental vaginal delivery, presented in numbers and percentages
Perineal tears 18 months Perineal tears will be presented in numbers and percentages
The use of epidural analgesia 18 months The use of epidural analgesia will be presented in numbers and percentages
Blood transfusion 18 months The need for blood transfusion will be presented in numbers and percentages
The use of non-medical pain relief in labour 18 months The use of non-medical pain relief will be presented in numbers and percentages.
Neonatal morbidity 18 months Neonatal morbidity will be presented in numbers and percentages.
initiation of oxytocin 18 months Initiation of oxytocin will be presented according to cervical dilatation in centimetres
The use of medical pain relief in labour 18 months The use of medical pain relief will be presented in numbers and percentages.
Childbirth experience 20 months Childbirth experience measured by the childbirth experience questionnaire, CEQ presented in total and mean scores according to the four domains in the CEQ questionnaire
Intermittent fetal monitoring 18 months The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages
Continuous fetal monitoring 18 months The use of continuous fetal monitoring will be presented in numbers and percentages
Admittance to Neonatal Intensive Care Unit 18 months Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages
Neonatal birth weight 18 months Neonatal birth weight will be presented in kilograms
Neonatal birth head circumference 18 months Neonatal head circumference will be presented in centimetres
Neonatal metabolic acidosis 18 months Metabolic acidosis will be presented in numbers and percentages
Neonatal gender 18 months Neonatal gender will be presented by numbers and percentages
Trial Locations
- Locations (10)
Akershus University Hospital, Ahus
🇳🇴Nordbyhagen, Akershus, Norway
Vestre Viken Helseforetak, Drammen
🇳🇴Drammen, Buskerud, Norway
Stavanger University Hospital
🇳🇴Stavanger, Rogaland, Norway
University Hospital Northern Norway, Tromsø
🇳🇴Tromsø, Troms, Norway
St.Olav University Hospital
🇳🇴Trondheim, Trøndelag, Norway
Haukeland University Hospital
🇳🇴Bergen, Vestland, Norway
Sørlandet Hospital Kristiansand
🇳🇴Kristiansand, Norway
Oslo university hospital Rikshospitalet
🇳🇴Oslo, Norway
Oslo University Hospital Ullevål
🇳🇴Oslo, Norway
Ostfold Hospital Trust
🇳🇴Greåker, Ostfold, Norway