The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia

Conditions
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Cesarean Section, Dystocia

Intervention / Treatment
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* Other: Knowledge Translation of labor management guidelines


Participation Criteria
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Eligibility Criteria
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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:
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention centers<br>Application of a knowledge translation strategy, of new clinical practice guidelines on labor management, to physicians and nurses caring for women in labor. Intervention centers will receive knowledge translation of labor management guidelines | Other: Knowledge Translation of labor management guidelines<br> <br> |
| No Intervention: Control centers<br>No intervention at control centers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cesarean section | Rate of Cesarean section in primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perinatal death | Rate of perinatal death for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery | 
| Rate of neonatal asphyxia | 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 | at delivery | 
| Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling | 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 | at delivery | 
| Rate of neonatal sepsis or suspected sepsis | Rate of neonatal sepsis or suspected sepsis for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery | 
| Rate of post partum hemorrhage | Rate of post partum hemorrhage for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery | 
| Rate of blood transfusion | Rate of blood transfusion for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery | 
| Rate of postpartum uterine artery/pelvic artery embolization | Rate of postpartum uterine artery/pelvic artery embolization for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | Within 30 days of delivery | 
| Rate of postpartum hysterectomy | Rate of postpartum hysterectomy for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | Within 30 days of delivery | 
| Rate of postpartum maternal intensive care unit (ICU) admission | Rate of postpartum maternal intensive care unit (ICU) admission for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus | at delivery |