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

U

University of Calgary

Status

Enrolling

Conditions

Cesarean Section, Dystocia

Treatments

Other: Knowledge Translation of labor management guidelines

Study type

Interventional

Funder types

Other

Identifiers

NCT02874443
REB16-1576

Details and patient eligibility

About

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

Full 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.

Enrollment

100,000 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100,000 participants in 2 patient groups

Intervention centers
Experimental group
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
Treatment:
Other: Knowledge Translation of labor management guidelines
Control centers
No Intervention group
Description:
No intervention at control centers

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Stephen Wood, MD MSc; Janice Skiffington, MSc

Data sourced from clinicaltrials.gov

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