The impact of a modified World Health Organization surgical safety checklist on maternal outcomes in a South African setting: A stratified cluster-randomised controlled trial.

BACKGROUND: In South Africa (SA), the Saving Mothers Reports have shown an alarming increase in deaths during or after caesarean delivery. OBJECTIVE: To improve maternal surgical safety in KwaZulu-Natal Province, SA, by implementing the modified World Health Organization surgical safety checklist for maternity care (MSSCL) in maternity operating theatres. METHODS: The study was a stratified cluster-randomised controlled trial conducted from March to November 2013. Study sites were 18 hospitals offering maternal surgical services in the public health sector. Patients requiring maternal surgical intervention at the study sites were included. Pre-intervention surgical outcomes were assessed. Training of healthcare personnel took place over 1 month, after which the MSSCL was implemented. Post-intervention surgical outcomes were assessed and compared with the pre-intervention findings and the control arm. The main outcome measure was the mean incidence rate ratios (IRRs) of adverse incidents associated with surgery. RESULTS: Significant improvements in the adverse incident rate per 1 000 procedures occurred with combined outcomes (IRR 0.805, 95% confidence interval (CI) 0.706 - 0.917), postoperative sepsis (IRR 0.619, 95% CI 0.451 - 0.849), referral to higher levels of care (IRR 1.409, 95% CI 1.066 - 1.862) and unscheduled return to the operating theatre (IRR 0.719, 95% CI 0.574 - 0.899) in the intervention arm. Subgroup analysis based on the quality of implementation demonstrated greater reductions in maternal mortality in hospitals that were good implementers of the MSSCL. CONCLUSIONS: Incorporation of the MSSCL into routine surgical practice has now been recommended for all public sector hospitals in SA, and emphasis should be placed on improving the quality of implementation.