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

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ClinicalTrials.gov Identifier: NCT05791630
Recruitment Status : Not yet recruiting
First Posted : March 30, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Stine Bernitz, Ostfold Hospital Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Labor Dystocia Labor Complication Labor Onset and Length Abnormalities Labor (Obstetrics)--Complications Experience, Life Progression Cesarean Section Complications Apgar; 4-7 at 1 Minute Other: the labour care guide (LCG) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20636 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Multicenter stepped wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Norwegian World Health Organisation Labour Care Guide Trial
Estimated Study Start Date : July 1, 2024
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2030
Arms and Interventions
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Arm Intervention/treatment
No Intervention: WHO partograph
all study sites use the WHO partograph as standard care in the first step of the trial
Experimental: WHO labour care guide
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


Outcome Measures
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Primary Outcome Measures :
  1. Intrapartum cesarean section [ Time Frame: 18 months ]
    the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.


Secondary Outcome Measures :
  1. Instrumental vaginal delivery [ Time Frame: 18 months ]
    The rate of instrumental vaginal delivery, presented in numbers and percentages

  2. Perineal tears [ Time Frame: 18 months ]
    Perineal tears will be presented in numbers and percentages

  3. Post partum hemorrhage [ Time Frame: 18 months ]
    Post partum hemorrhage will be presented in numbers and percentages.

  4. Estimated blood loss [ Time Frame: 18 months ]
    Estimated blood loss will be presented in ml of blood loss

  5. Blood transfusion [ Time Frame: 18 months ]
    The need for blood transfusion will be presented in numbers and percentages

  6. The use of oxytocin [ Time Frame: 18 months ]
    The use of oxytocin will be presented in numbers and percentages

  7. Dosage of oxytocin [ Time Frame: 18 months ]
    The dosages of oxytocin will be presented in milli units (m/U)

  8. Duration of oxytocin [ Time Frame: 18 months ]
    The duration of oxytocin will be presented in hours and minutes

  9. initiation of oxytocin [ Time Frame: 18 months ]
    Initiation of oxytocin will be presented according to cervical dilatation in centimetres

  10. Labour duration [ Time Frame: 18 months ]
    Labour duration will be presented in hours and minutes

  11. The use of epidural analgesia [ Time Frame: 18 months ]
    The use of epidural analgesia will be presented in numbers and percentages

  12. Duration of epidural analgesia [ Time Frame: 18 months ]
    Duration of epidural analgesia will be presented hours and minutes

  13. Initiation of epidural analgesia [ Time Frame: 18 months ]
    The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres

  14. The use of medical pain relief in labour [ Time Frame: 18 months ]
    The use of medical pain relief will be presented in numbers and percentages.

  15. The use of non-medical pain relief in labour [ Time Frame: 18 months ]
    The use of non-medical pain relief will be presented in numbers and percentages.

  16. Childbirth experience [ Time Frame: 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

  17. Intermittent fetal monitoring [ Time Frame: 18 months ]
    The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages

  18. Continuous fetal monitoring [ Time Frame: 18 months ]
    The use of continuous fetal monitoring will be presented in numbers and percentages

  19. Neonatal Apgar scores [ Time Frame: 18 months ]
    Apgar scores 1/5/10 minutes post partum presented in values of 0-10

  20. Neonatal metabolic acidosis [ Time Frame: 18 months ]
    Metabolic acidosis will be presented in numbers and percentages

  21. Admittance to Neonatal Intensive Care Unit [ Time Frame: 18 months ]
    Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages

  22. Duration of stay at neonatal Intensive Care Unit [ Time Frame: 18 months ]
    Duration of stay at neonatal Intensive Care Unit will be presented days

  23. Neonatal gender [ Time Frame: 18 months ]
    Neonatal gender will be presented by numbers and percentages

  24. Neonatal birth weight [ Time Frame: 18 months ]
    Neonatal birth weight will be presented in kilograms

  25. Neonatal birth head circumference [ Time Frame: 18 months ]
    Neonatal head circumference will be presented in centimetres

  26. Neonatal morbidity [ Time Frame: 18 months ]
    Neonatal morbidity will be presented in numbers and percentages.


Other Outcome Measures:
  1. Continuous support in labour [ Time Frame: 18 months ]
    Continuous support will be presented as yes/no and according to cervical dilatation

  2. Birthing position [ Time Frame: 18 months ]
    The birthing position will registered and presented in numbers and percentages

  3. Fetal presentation [ Time Frame: 18 months ]
    The fetal delivery presentation will be registered and presented in numbers and percentages

  4. Perineal support [ Time Frame: 18 months ]
    Perineal support will be registered in numbers and percentages

  5. Skin-to-skin-contact [ Time Frame: 18 months ]
    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

  6. Breast feeding [ Time Frame: 18 months ]
    Breastfeeding will be presented as number and percentages

  7. The use of formula [ Time Frame: 18 months ]
    The use of formula will be registered as number and percentages

  8. Usability of the Labour Care Guide [ Time Frame: 24 months ]
    Midwives' and doctors' experience with LCG use assessed through a customized questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women in labour and delivery
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05791630


Contacts
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Contact: Stine Bernitz, PhD +4790944715 stine.bernitz@oslomet.no
Contact: Rebecka Dalbye, PhD +4745247873 rebecka.dalbye@oslomet.no

Locations
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Norway
Ostfold Hospital Trust
Greåker, Ostfold, Norway, 1714
Contact: Rebecka Dalbye, PhD    +4745247873    rebda@oslomet.no   
Contact: Waleed Ghanima, PhD    +4741303440    waleed.ghanima@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
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Principal Investigator: Stine Bernitz, PhD Ostfold Hospital Trust
More Information
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Responsible Party: Stine Bernitz, Professor/researcher, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT05791630    
Other Study ID Numbers: 2023084
First Posted: March 30, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be shared according to demand and aim
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dystocia
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases