Clinical trial NCT02874443: The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Official title: The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section, Dystocia
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 100000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a clustered randomized controlled trial of a knowledge translation intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent is to reduce the rate of cesarean section (CS) in first time mothers at term (\>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. The guidelines were developed from data from the Consortium for Safe Labor. The unit of randomization will be sites in Alberta that deliver

Detailed description: Cluster randomized controlled trial of a knowledge translation intervention of new guidelines for the diagnosis of poor progress in labor. The intervention will be randomized to centres (the clusters) in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually, with stratification based on facility type and geographic location. Clustering by centre and not individual caregivers (nurses/physicians) is necessary to prevent leakage or crossover of the intervention to controls. As all participating centres will eventually receive the intervention, the biostatistician will generate a randomization into two "waves". The intervention will be introduced sequentially by strata (Calgary, Edmonton, regional centres, rural centres) to the first "wave" hospitals in multi-week run-in periods after which those strata will be revisited for roll-out to the second "wave" hospitals.

Eligibility criteria: Inclusion Criteria:

* Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually

Exclusion Criteria:

Primary outcomes:
measure: Rate of Cesarean section
timeFrame: at delivery
Secondary outcomes:
measure: Rate of perinatal death
timeFrame: at delivery
measure: Rate of neonatal asphyxia
timeFrame: at delivery
measure: Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling
timeFrame: at delivery
measure: Rate of neonatal sepsis or suspected sepsis
timeFrame: at delivery
measure: Rate of post partum hemorrhage
timeFrame: at delivery
measure: Rate of blood transfusion
timeFrame: at delivery
measure: Rate of postpartum uterine artery/pelvic artery embolization
timeFrame: Within 30 days of delivery
measure: Rate of postpartum hysterectomy
timeFrame: Within 30 days of delivery
measure: Rate of postpartum maternal intensive care unit (ICU) admission
timeFrame: at delivery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen Wood, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: