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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874443
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Wood, University of Calgary

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
Rate of Cesarean section in primiparous women in labor. [ Time Frame: at delivery ]
Change History Complete list of historical versions of study NCT02874443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • Perinatal death [ Time Frame: at delivery ]
  • Neonatal intensive care unit (NICU) admission with arterial blood gasses pH < 7 and base excess >=12 or NICU admission with Apgar at 5 minutes < 7 [ Time Frame: at delivery ]
  • moderate or severe asphyxia or meets criteria for therapeutic cooling [ Time Frame: at delivery ]
  • Neonatal sepsis or suspected sepsis [ Time Frame: at delivery ]
  • Post partum hemorrhage/blood transfusion [ Time Frame: at delivery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Official Title  ICMJE The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cesarean Section, Dystocia
Intervention  ICMJE Other: Knowledge Translation of labor management guidelines
Study Arms  ICMJE
  • 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

    Intervention: Other: Knowledge Translation of labor management guidelines
  • No Intervention: Control centers
    No intervention at control centers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2016)
40000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen Wood, MD MSc 403-9441438 slwood@ucalgary.ca
Contact: Janice Skiffington, MSc 403-944-8446 janice.skiffington@ahs.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874443
Other Study ID Numbers  ICMJE REB16-1576
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Wood, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Wood, MD MSc University of Calgary
PRS Account University of Calgary
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP