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Clean-CS: A Program to Improve the Safety of C-section
Not Recruiting
Trial ID: NCT04812522
Purpose
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.
Official Title
CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section - CLEAN-CS: A Cluster-Randomized, Stepped Wedge Interventional Trial to Reduce Postoperative Infections Following Cesarean Delivery
Stanford Investigator(s)
Thomas G Weiser, MD, MPH
Clinical Professor, Surgery - General Surgery
Eligibility
Inclusion Criteria:
- Any patient undergoing obstetric and gynecologic surgery at any time in one of the
targeted operating theatres is eligible for inclusion
Exclusion Criteria:
- there will be no exclusion criteria
Intervention(s):
behavioral: Clean Cut program
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Thomas Weiser
xxx-xxxx