Cesarean Section, Dystocia
Conditions
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.
Interventions
OTHERKnowledge Translation of labor management guidelines
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Cesarean section | at delivery | Rate of Cesarean section in primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood transfusion | at delivery | Rate of blood transfusion for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of perinatal death | at delivery | Rate of perinatal death for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of neonatal asphyxia | at delivery | Neonatal asphyxia is defined as intrapartum stillbirth or neonatal death from asphyxia (Perinatal Society of Australia and New Zealand coding) or Neonatal Intensive Care Unit admission and at least two of: a. Apgar score of ≤5 at 10 minutes; b. Mechanical ventilation or chest compressions for resuscitation within 10 minutes; c. Cord pH \< 7.00 (venous or arterial), or arterial base excess ≥ 12 at birth. Rate of neonatal asphyxia for deliveries involving primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling | at delivery | Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling for deliveries involving primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of post partum hemorrhage | at delivery | Rate of post partum hemorrhage for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of postpartum uterine artery/pelvic artery embolization | Within 30 days of delivery | Rate of postpartum uterine artery/pelvic artery embolization for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of postpartum hysterectomy | Within 30 days of delivery | Rate of postpartum hysterectomy for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of postpartum maternal intensive care unit (ICU) admission | at delivery | Rate of postpartum maternal intensive care unit (ICU) admission for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
| Rate of neonatal sepsis or suspected sepsis | at delivery | Rate of neonatal sepsis or suspected sepsis for deliveries involving primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus |
Countries
Canada
Outcome results
None listed