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

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 Overview

• Status: Recruiting
• Conditions: Cesarean Section, Dystocia
• Intervention / Treatment: Other: Knowledge Translation of labor management guidelines

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: Interventional
• Enrollment (Estimated): 100000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janice Skiffington, MSc; Phone Number: 403-944-8446; Email: janice.skiffington@ahs.ca
• Study Contact Backup: Name: Stephen Wood, MD MSc; Phone Number: 403-9441438; Email: slwood@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • University of Calgary
      • Contact: Stephen Wood, MD; Phone Number: 403-944-1438; Email: slwood@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Stephen Wood, MD MSc, University of Calgary

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimated): August 22, 2016

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dystocia
• Other Study ID Numbers: REB16-1576