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

NCT ID: NCT02874443

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88918 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-03-30

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.

Conditions

Cesarean Section, Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Knowledge Translation of labor management guidelines

Intervention Type: OTHER

Control centers

No intervention at control centers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Knowledge Translation of labor management guidelines

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Wood, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

References

Wood S, Skiffington J, Brant R, Crawford S, Hicks M, Mohammad K, Mrklas KJ, Tang S, Metcalfe A; REDUCED Trial Team. The REDUCED trial: a cluster randomized trial for REDucing the utilization of CEsarean delivery for dystocia. Am J Obstet Gynecol. 2023 May;228(5S):S1095-S1103. doi: 10.1016/j.ajog.2022.10.038. Epub 2023 Mar 16.

Reference Type: DERIVED

PMID: 37164490 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REB16-1576

Identifier Type: -

Identifier Source: org_study_id