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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOstfold Hospital Trust

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women in active labour

Labour and delivery at study sites

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • the labour care guide (LCG)

    Other intervention

    The labour care guide is a tool to be used for assessing labour progression and monitoring care in labour

Treatment groups

23,650 Participants
are divided into 2 treatment groups
Group A: WHO partographNo intervention 0 interventions
Group B: WHO labour care guideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intrapartum cesarean section

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

Time frame
18 months

Secondary outcomes

1

Instrumental vaginal delivery

The rate of instrumental vaginal delivery, presented in numbers and percentages

Time frame
18 months
2

Perineal tears

Perineal tears will be presented in numbers and percentages

Time frame
18 months
3

Post partum hemorrhage

Post partum hemorrhage will be presented in numbers and percentages.

Time frame
18 months
4

Estimated blood loss

Estimated blood loss will be presented in ml of blood loss

Time frame
18 months

Other outcomes

1

Continuous support in labour

Continuous support will be presented as yes/no and according to cervical dilatation

Time frame
18 months
2

Birthing position

The birthing position will registered and presented in numbers and percentages

Time frame
18 months
3

Fetal presentation

The fetal delivery presentation will be registered and presented in numbers and percentages

Time frame
18 months
4

Perineal support

Perineal support will be registered in numbers and percentages

Time frame
18 months

Sponsors and contacts

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