Labor DystociaNORWELNCT05791630
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
A study testing the labour care guide (LCG) in people with Labor Dystocia and Labor Complication, run by Ostfold Hospital Trust at 10 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Dystocia, Labor Complication, Labor Onset and Length Abnormalities
- What is being tested?
- the labour care guide (LCG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,650 participants
- Where
- 10 sitesNorway
- Study dates
- 1 Apr 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women in active labour
- Labour and delivery at study sites
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Norway10 sites, 10 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5009
Jørg Kessler, ph.d., +4797709603, jorg.kessler@helse-bergen.no
- Recruiting
Vestre Viken Helseforetak, Drammen
Drammen, Buskerud, 3004
Shruti Sharma, ph.d., +4732803000, Shruti.Sharma@vestreviken.no
- Not yet recruiting
Ostfold Hospital Trust
Greåker, Østfold fylke, 1714
Rebecka Dalbye, PhD, +4745247873, rebda@oslomet.no
Waleed Ghanima, PhD, +4741303440, waleed.ghanima@so-hf.no
- Recruiting
Sørlandet Hospital Kristiansand
Kristiansand, Kristiansand, 4615
Janne Rossen, ph.d., +4798464129, janne.rossen@sshf.no
- Recruiting
Akershus University Hospital, Ahus
Nordbyhagen, Akershus, 1478
Camilla M Haavaldsen, +4767960000, marit.camilla.haavaldsen@ahus.no
- Recruiting
Oslo university hospital Rikshospitalet
Oslo, Oslo, 0372
Trond F Michelsen, ph.d., +4740042502, trmi1@ous-hf.no
- Recruiting
Oslo University Hospital Ullevål
Oslo, Oslo, 0450
Anne F Jacobsen, ph.d., +4792814298, UXAFJA@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger, Rogaland, 4019
Ragnar K Sande, ph.d., +4797977379, ragnar.kvie.sande@sus.no
Elsa Lindtjørn, MSC, +4791693929, elsa@lindtjorn.no
- Recruiting
University Hospital Northern Norway, Tromsø
Tromsø, Troms, 9038
Åse Torunn Pettersen, MSC, +4791332077, aase.torunn.revholt.pettersen@unn.no
- Recruiting
St.Olav University Hospital
Trondheim, Trøndelag, 7006
Elisabeth Magnussen, ph.d., +4792205929, elisabeth.magnussen@stolav.no
About this study
Official title: The Norwegian World Health Organisation Labour Care Guide Trial
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.
Read the 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
- Being tested
- the labour care guide (LCG)
- Medical subject headings
- Dystocia, Obstetric Labor Complications, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the labour care guide (LCG)Other
The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour
| Study group | Role | What they receive |
|---|---|---|
| WHO partograph | No intervention | all study sites use the WHO partograph as standard care in the first step of the trial |
| WHO labour care guide | Experimental | All study sites will cross over to the intervention according to randomization and use the LCG for assessing labour progression and wellbeing in labour Receives: Other: the labour care guide (LCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapartum cesarean section
the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
Measured: 18 months
Secondary outcomes (26)
Instrumental vaginal delivery
The rate of instrumental vaginal delivery, presented in numbers and percentages
Measured: 18 months
Perineal tears
Perineal tears will be presented in numbers and percentages
Measured: 18 months
Post partum hemorrhage
Post partum hemorrhage will be presented in numbers and percentages.
Measured: 18 months
Estimated blood loss
Estimated blood loss will be presented in ml of blood loss
Measured: 18 months
Blood transfusion
The need for blood transfusion will be presented in numbers and percentages
Measured: 18 months
The use of oxytocin
The use of oxytocin will be presented in numbers and percentages
Measured: 18 months
Dosage of oxytocin
The dosages of oxytocin will be presented in milli units (m/U)
Measured: 18 months
Duration of oxytocin
The duration of oxytocin will be presented in hours and minutes
Measured: 18 months
initiation of oxytocin
Initiation of oxytocin will be presented according to cervical dilatation in centimetres
Measured: 18 months
Labour duration
Labour duration will be presented in hours and minutes
Measured: 18 months
The use of epidural analgesia
The use of epidural analgesia will be presented in numbers and percentages
Measured: 18 months
Duration of epidural analgesia
Duration of epidural analgesia will be presented hours and minutes
Measured: 18 months
Initiation of epidural analgesia
The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres
Measured: 18 months
The use of medical pain relief in labour
The use of medical pain relief will be presented in numbers and percentages.
Measured: 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.
Measured: 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
Measured: 20 months
Intermittent fetal monitoring
The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages
Measured: 18 months
Continuous fetal monitoring
The use of continuous fetal monitoring will be presented in numbers and percentages
Measured: 18 months
Neonatal Apgar scores
Apgar scores 1/5/10 minutes post partum presented in values of 0-10
Measured: 18 months
Neonatal metabolic acidosis
Metabolic acidosis will be presented in numbers and percentages
Measured: 18 months
Admittance to Neonatal Intensive Care Unit
Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages
Measured: 18 months
Duration of stay at neonatal Intensive Care Unit
Duration of stay at neonatal Intensive Care Unit will be presented days
Measured: 18 months
Neonatal gender
Neonatal gender will be presented by numbers and percentages
Measured: 18 months
Neonatal birth weight
Neonatal birth weight will be presented in kilograms
Measured: 18 months
Neonatal birth head circumference
Neonatal head circumference will be presented in centimetres
Measured: 18 months
Neonatal morbidity
Neonatal morbidity will be presented in numbers and percentages.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor DystociaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 23,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Bernitz, Ostfold Hospital Trust
- Investigators
- Stine Bernitz, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791630
- Sponsor's protocol ID
- 2023084
- Acronym
- NORWEL
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared according to demand and aim
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian World Health Organisation Labour Care Guide Trial
- ClinicalTrials.gov ID
- NCT05791630
- Acronym / sponsor ID
- NORWEL / 2023084
- Conditions
- Labor Dystocia, Labor Complication, Labor Onset and Length Abnormalities, Labor (Obstetrics)--Complications, Experience, Life, Progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23,650 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| WHO partograph | No intervention | –all study sites use the WHO partograph as standard care in the first step of the trial |
| WHO labour care guide | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women in active labour
- Labour and delivery at study sites
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the labour care guide (LCG)The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour | Other | WHO labour care guide |
Primary outcome
Intrapartum cesarean section
Time frame: 18 months
the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.
26 secondary outcomes
Instrumental vaginal delivery
Time frame: 18 months
Perineal tears
Time frame: 18 months
Post partum hemorrhage
Time frame: 18 months
Estimated blood loss
Time frame: 18 months
Blood transfusion
Time frame: 18 months
The use of oxytocin
Time frame: 18 months
Dosage of oxytocin
Time frame: 18 months
Duration of oxytocin
Time frame: 18 months
initiation of oxytocin
Time frame: 18 months
Labour duration
Time frame: 18 months
The use of epidural analgesia
Time frame: 18 months
Duration of epidural analgesia
Time frame: 18 months
Initiation of epidural analgesia
Time frame: 18 months
The use of medical pain relief in labour
Time frame: 18 months
The use of non-medical pain relief in labour
Time frame: 18 months
Childbirth experience
Time frame: 20 months
Intermittent fetal monitoring
Time frame: 18 months
Continuous fetal monitoring
Time frame: 18 months
Neonatal Apgar scores
Time frame: 18 months
Neonatal metabolic acidosis
Time frame: 18 months
Admittance to Neonatal Intensive Care Unit
Time frame: 18 months
Duration of stay at neonatal Intensive Care Unit
Time frame: 18 months
Neonatal gender
Time frame: 18 months
Neonatal birth weight
Time frame: 18 months
Neonatal birth head circumference
Time frame: 18 months
Neonatal morbidity
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Will be shared according to demand and aim
Related trials for Labor Dystocia
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Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
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Maternal Maneuvers During Prolonged Labor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stine Bernitz, PhD principal investigator
Ostfold Hospital Trust
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the labour care guide (LCG) in people with Labor Dystocia and Labor Complication, run by Ostfold Hospital Trust at 10 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stine Bernitz, PhD (+4790944715, stine.bernitz@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapartum cesarean section (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.