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

Cesarean Section Complications Clinical Trial

— NORWEL  

Official title:

The Norwegian World Health Organisation Labour Care Guide Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05791630
• Other study ID #: 2023084
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Ostfold Hospital Trust
• Contact: Stine Bernitz, PhD
• Phone: +4790944715
• Email: stine.bernitz[@]oslomet.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20636
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women in active labour

• Labour and delivery at study sites

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Apgar; 4-7 at 1 Minute
• Cesarean Section Complications
• Dystocia
• Experience, Life
• Labor (Obstetrics)--Complications
• Labor Complication
• Labor Dystocia
• Labor Onset and Length Abnormalities
• Obstetric Labor Complications
• Progression

Intervention

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

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Greåker	Ostfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous support in labour	Continuous support will be presented as yes/no and according to cervical dilatation	18 months
Other	Birthing position	The birthing position will registered and presented in numbers and percentages	18 months
Other	Fetal presentation	The fetal delivery presentation will be registered and presented in numbers and percentages	18 months
Other	Perineal support	Perineal support will be registered in numbers and percentages	18 months
Other	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	18 months
Other	Breast feeding	Breastfeeding will be presented as number and percentages	18 months
Other	The use of formula	The use of formula will be registered as number and percentages	18 months
Other	Usability of the Labour Care Guide	Midwives' and doctors' experience with LCG use assessed through a customized questionnaire	24 months
Primary	Intrapartum cesarean section	the rate of intrapartum cesarean sections (ICS), presented in numbers and percentages.	18 months
Secondary	Instrumental vaginal delivery	The rate of instrumental vaginal delivery, presented in numbers and percentages	18 months
Secondary	Perineal tears	Perineal tears will be presented in numbers and percentages	18 months
Secondary	Post partum hemorrhage	Post partum hemorrhage will be presented in numbers and percentages.	18 months
Secondary	Estimated blood loss	Estimated blood loss will be presented in ml of blood loss	18 months
Secondary	Blood transfusion	The need for blood transfusion will be presented in numbers and percentages	18 months
Secondary	The use of oxytocin	The use of oxytocin will be presented in numbers and percentages	18 months
Secondary	Dosage of oxytocin	The dosages of oxytocin will be presented in milli units (m/U)	18 months
Secondary	Duration of oxytocin	The duration of oxytocin will be presented in hours and minutes	18 months
Secondary	initiation of oxytocin	Initiation of oxytocin will be presented according to cervical dilatation in centimetres	18 months
Secondary	Labour duration	Labour duration will be presented in hours and minutes	18 months
Secondary	The use of epidural analgesia	The use of epidural analgesia will be presented in numbers and percentages	18 months
Secondary	Duration of epidural analgesia	Duration of epidural analgesia will be presented hours and minutes	18 months
Secondary	Initiation of epidural analgesia	The initiation of epidural analgesia will be presented according to cervical dilatation presented in centimetres	18 months
Secondary	The use of medical pain relief in labour	The use of medical pain relief will be presented in numbers and percentages.	18 months
Secondary	The use of non-medical pain relief in labour	The use of non-medical pain relief will be presented in numbers and percentages.	18 months
Secondary	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	20 months
Secondary	Intermittent fetal monitoring	The use of intermittent fetal monitoring (pinard and doppler) will be presented in numbers and percentages	18 months
Secondary	Continuous fetal monitoring	The use of continuous fetal monitoring will be presented in numbers and percentages	18 months
Secondary	Neonatal Apgar scores	Apgar scores 1/5/10 minutes post partum presented in values of 0-10	18 months
Secondary	Neonatal metabolic acidosis	Metabolic acidosis will be presented in numbers and percentages	18 months
Secondary	Admittance to Neonatal Intensive Care Unit	Admittance to the Neonatal Intensive Care Unit will be presented in numbers and percentages	18 months
Secondary	Duration of stay at neonatal Intensive Care Unit	Duration of stay at neonatal Intensive Care Unit will be presented days	18 months
Secondary	Neonatal gender	Neonatal gender will be presented by numbers and percentages	18 months
Secondary	Neonatal birth weight	Neonatal birth weight will be presented in kilograms	18 months
Secondary	Neonatal birth head circumference	Neonatal head circumference will be presented in centimetres	18 months
Secondary	Neonatal morbidity	Neonatal morbidity will be presented in numbers and percentages.	18 months