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

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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

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

Condition or disease Intervention/treatment Phase
Cesarean Section, Dystocia Other: Knowledge Translation of labor management guidelines Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Study Start Date : October 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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

Other: Knowledge Translation of labor management guidelines
No Intervention: Control centers
No intervention at control centers



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874443


Contacts
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Contact: Stephen Wood, MD MSc 403-9441438 slwood@ucalgary.ca
Contact: Janice Skiffington, MSc 403-944-8446 janice.skiffington@ahs.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Stephen Wood, MD    403-944-1438    slwood@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Stephen Wood, MD MSc University of Calgary
  Study Documents (Full-Text)

Documents provided by Stephen Wood, University of Calgary:

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Responsible Party: Stephen Wood, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02874443     History of Changes
Other Study ID Numbers: REB16-1576
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Dystocia
Obstetric Labor Complications
Pregnancy Complications