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NCT Number: NCT05791630

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

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.

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Key information

Conditions

Labor Dystocia Apgar; 4-7 at 1 Minute Cesarean Section Complications Disease Attributes Disease Progression Dystocia Experience, Life Female Urogenital Diseases and Pregnancy Complications Labor (Obstetrics)--Complications Labor Complication Labor Onset and Length Abnormalities Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Progression Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Ahus, Nordbyhagen, Akershus, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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

Primary outcomes

  1. Intrapartum cesarean section

    Time frame: 18 months

    the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.

Secondary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecka Dalbye, PhD

CONTACT

[email protected]

+4745247873

Stine Bernitz, PhD

CONTACT

[email protected]

+4790944715

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

The Norwegian World Health Organisation Labour Care Guide Trial

Acronym: NORWEL

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Mar 30, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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