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Clean-CS: A Program to Improve the Safety of C-section

NCT04812522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10506

Last updated 2023-10-04

No results posted yet for this study

Summary

Executive summary: Cesarean delivery, or section (CS), is the single most common surgical procedure performed. Estimates indicate that in low resource settings, CS comprises up to 50% of more of the total volume of operations performed. The World Health Organization recommends national CS rates of between 10-15% to save lives and improve maternal and neonatal outcomes. Population-based work indicates that CS rates of up to 19% are demonstrably related to improved maternal and neonatal survival. However, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. In low resource settings, complication rates are particularly high.

The intervention being tested is based on a previously developed program called Clean Cut. Clean Cut is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis. It was successfully piloted in five surgical departments in Ethiopia, and reduced the relative risk of infection by 35%. This has been adapted specifically for obstetric and gynecological operations and will be evaluated in a cluster randomized stepped wedge trial design in ten maternity hospitals/departments in Ethiopia in order to reduce infections and other complications for women undergoing cesarean delivery and other obstetric and gynecologic operations.

Conditions

  • Cesarean Section Complications

Interventions

BEHAVIORAL

Clean Cut program

Clean Cut, is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis

Sponsors & Collaborators

  • Ethiopian Society of Obstetricians and Gynecologists

    collaborator UNKNOWN

  • The Lifebox Foundation

    lead OTHER

Principal Investigators

  • Thomas G Weiser, MD MPH · The Lifebox Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2023-01-31
Completion
2023-03-10

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812522 on ClinicalTrials.gov