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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2019

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

  • Other: Knowledge Translation of labor management guidelines

Arms, Groups and Cohorts

  • Experimental: Intervention centers
    • 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
  • No Intervention: Control centers
    • No intervention at control centers

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Cesarean section
    • Time Frame: at delivery
    • Rate of Cesarean section in primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus

Secondary Measures

  • Rate of perinatal death
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 neonatal sepsis or suspected sepsis
    • Time Frame: 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
  • Rate of post partum hemorrhage
    • Time Frame: at delivery
    • Rate of post partum hemorrhage for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
  • Rate of blood transfusion
    • Time Frame: at delivery
    • Rate of blood transfusion for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
  • Rate of postpartum uterine artery/pelvic artery embolization
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Calgary
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephen Wood, Associate Professor – University of Calgary
  • Overall Official(s)
    • Stephen Wood, MD MSc, Principal Investigator, University of Calgary
  • Overall Contact(s)
    • Stephen Wood, MD MSc, 403-9441438, slwood@ucalgary.ca

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