Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

The Lifebox Foundation

Collaborator: Ethiopian Society of Obstetricians and Gynecologists

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Clean Cut program

Phase:

N/A

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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting