NCT04812522: Clean-CS

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

Completed NA Last updated 4 October 2023

What this trial tests

NA trial testing Clean Cut program in Cesarean Section Complications in 10,506 participants. Completed in 10 March 2023.

Timeline

26 August 2021

Primary endpoint
31 January 2023

10 March 2023

Quick facts

Lead sponsor	The Lifebox Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	10,506
Start date	26 August 2021
Primary completion	31 January 2023
Estimated completion	10 March 2023
Sites	10 locations across Ethiopia

Drugs / interventions tested

• Clean Cut program

Conditions studied

• Cesarean Section Complications — all drugs for Cesarean Section Complications →

Sponsor

The Lifebox Foundation

Who can join

Eligibility, female only, with Cesarean Section Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial.
   Mammo TN, Feyssa MD, Haile ST, Fikre T, et al · · 2022 · cited 4× · PMID 35986400 · DOI 10.1186/s13063-022-06500-9
2. A Perioperative Quality Improvement Program for Cesarean Delivery in Ethiopia: A Stepped-Wedge Cluster Randomized Clinical Trial.
   Mammo TN, Feyssa MD, Nofal MR, Gebeyehu N, et al · · 2024 · cited 1× · PMID 39163043 · DOI 10.1001/jamanetworkopen.2024.28910