Cesarean Section Complications Clinical Trial
— NORWELOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Ostfold Hospital Trust | Greåker | Ostfold |
Lead Sponsor | Collaborator |
---|---|
Ostfold Hospital Trust |
Norway,
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 |
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