An interventional study of the labour care guide (LCG) in Labor Dystocia, Labor Complication and Labor Onset and Length Abnormalities, sponsored by Ostfold Hospital Trust. Recruiting at 10 sites in Norway. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 23,650 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
all study sites use the WHO partograph as standard care in the first step of the trial
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)
The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour
Intrapartum cesarean section
the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
Time frame: 18 months
Instrumental vaginal delivery
The rate of instrumental vaginal delivery, presented in numbers and percentages
Time frame: 18 months
Perineal tears
Perineal tears will be presented in numbers and percentages
Time frame: 18 months
Post partum hemorrhage
Post partum hemorrhage will be presented in numbers and percentages.
Time frame: 18 months
Estimated blood loss
Estimated blood loss will be presented in ml of blood loss
Time frame: 18 months
Blood transfusion
The need for blood transfusion will be presented in numbers and percentages
Time frame: 18 months
The use of oxytocin
The use of oxytocin will be presented in numbers and percentages
Time frame: 18 months
Dosage of oxytocin
The dosages of oxytocin will be presented in milli units (m/U)
Time frame: 18 months
Duration of oxytocin
The duration of oxytocin will be presented in hours and minutes
Time frame: 18 months
initiation of oxytocin
Initiation of oxytocin will be presented according to cervical dilatation in centimetres
Time frame: 18 months
Labour duration
Labour duration will be presented in hours and minutes
Time frame: 18 months
The use of epidural analgesia
The use of epidural analgesia will be presented in numbers and percentages
Time frame: 18 months
Duration of epidural analgesia
Duration of epidural analgesia will be presented hours and minutes
Time frame: 18 months
Initiation of epidural analgesia
The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres
Time frame: 18 months
The use of medical pain relief in labour
The use of medical pain relief will be presented in numbers and percentages.
Time frame: 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.
Time frame: 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
Time frame: 20 months
Intermittent fetal monitoring
The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages
Time frame: 18 months
Continuous fetal monitoring
The use of continuous fetal monitoring will be presented in numbers and percentages
Time frame: 18 months
Neonatal Apgar scores
Apgar scores 1/5/10 minutes post partum presented in values of 0-10
Time frame: 18 months
Neonatal metabolic acidosis
Metabolic acidosis will be presented in numbers and percentages
Time frame: 18 months
Admittance to Neonatal Intensive Care Unit
Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages
Time frame: 18 months
Duration of stay at neonatal Intensive Care Unit
Duration of stay at neonatal Intensive Care Unit will be presented days
Time frame: 18 months
Neonatal gender
Neonatal gender will be presented by numbers and percentages
Time frame: 18 months
Neonatal birth weight
Neonatal birth weight will be presented in kilograms
Time frame: 18 months
Neonatal birth head circumference
Neonatal head circumference will be presented in centimetres
Time frame: 18 months
Neonatal morbidity
Neonatal morbidity will be presented in numbers and percentages.
Time frame: 18 months
Continuous support in labour
Continuous support will be presented as yes/no and according to cervical dilatation
Time frame: 18 months
Birthing position
The birthing position will registered and presented in numbers and percentages
Time frame: 18 months
Fetal presentation
The fetal delivery presentation will be registered and presented in numbers and percentages
Time frame: 18 months
Perineal support
Perineal support will be registered in numbers and percentages
Time frame: 18 months
Skin-to-skin-contact
Immediate skin-to-skin-contact will be registered as yes/no and time for immediate skin-to-skin-contact will be presented in hours and minutes
Time frame: 18 months
Breast feeding
Breastfeeding will be presented as number and percentages
Time frame: 18 months
The use of formula
The use of formula will be registered as number and percentages
Time frame: 18 months
Usability of the Labour Care Guide
Midwives' and doctors' experience with LCG use assessed through a customized questionnaire
Time frame: 24 months
Plan to share: Yes — Will be shared according to demand and aim
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: from onset of trial until five years after the trial has ended
Access criteria: if the purpose is stated and acceptable and presented by scientific personnel
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Ostfold Hospital Trust