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

University of Calgary88,918 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

88,918

Conditions

Cesarean Section, Dystocia

Interventions

Knowledge Translation of labor management guidelinesOTHER

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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:

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Rate of Cesarean section

Rate of Cesarean section in primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus

Time frame: at delivery

Secondary Outcomes

Rate of perinatal death

Rate of perinatal death for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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