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

Primary Purpose

Cesarean Section, Dystocia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knowledge Translation of labor management guidelines
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section, Dystocia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention centers

Control centers

Arm Description

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 at control centers

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of perinatal death
Rate of perinatal death for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
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
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
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
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
Rate of blood transfusion
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
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
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
Rate of postpartum maternal intensive care unit (ICU) admission for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus

Full Information

First Posted
August 17, 2016
Last Updated
February 24, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02874443
Brief Title
The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Acronym
REDUCED
Official Title
The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Dystocia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention centers
Arm Type
Experimental
Arm Description
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
Arm Title
Control centers
Arm Type
No Intervention
Arm Description
No intervention at control centers
Intervention Type
Other
Intervention Name(s)
Knowledge Translation of labor management guidelines
Primary Outcome Measure Information:
Title
Rate of Cesarean section
Description
Rate of Cesarean section in primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
Rate of perinatal death
Description
Rate of perinatal death for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
at delivery
Title
Rate of neonatal asphyxia
Description
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
Title
Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling
Description
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
Title
Rate of neonatal sepsis or suspected sepsis
Description
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
Title
Rate of post partum hemorrhage
Description
Rate of post partum hemorrhage for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
at delivery
Title
Rate of blood transfusion
Description
Rate of blood transfusion for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
at delivery
Title
Rate of postpartum uterine artery/pelvic artery embolization
Description
Rate of postpartum uterine artery/pelvic artery embolization for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
Within 30 days of delivery
Title
Rate of postpartum hysterectomy
Description
Rate of postpartum hysterectomy for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
Within 30 days of delivery
Title
Rate of postpartum maternal intensive care unit (ICU) admission
Description
Rate of postpartum maternal intensive care unit (ICU) admission for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Time Frame
at delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Wood, MD MSc
Phone
403-9441438
Email
slwood@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Janice Skiffington, MSc
Phone
403-944-8446
Email
janice.skiffington@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Wood, MD MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Wood, MD
Phone
403-944-1438
Email
slwood@ucalgary.ca

12. IPD Sharing Statement

Learn more about this trial

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

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