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

Not Applicable

Recruiting

• Conditions: Cesarean Section, Dystocia
• Interventions: Other: Knowledge Translation of labor management guidelines

• Registration Number: NCT02874443
• Lead Sponsor: 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-22
• Study Start: 2016-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100000

Inclusion Criteria

• Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention centers	Knowledge Translation of labor management guidelines	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of perinatal death	at delivery	Rate of perinatal death for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Rate of postpartum hysterectomy	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 post partum hemorrhage	at delivery	Rate of post partum hemorrhage for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Rate of postpartum uterine artery/pelvic artery embolization	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 blood transfusion	at delivery	Rate of blood transfusion for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Rate of postpartum maternal intensive care unit (ICU) admission	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
Rate of neonatal asphyxia	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	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	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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada