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Improving Obstetrics Surgical Safety in KwaZulu-Natal - Trial PACTR201501000981262

Access comprehensive clinical trial information for PACTR201501000981262 through Pure Global AI's free database. This Not Applicable trial is sponsored by Dr Mergan Naidoo and is currently Completed. The study focuses on Pregnancy and Childbirth; Surgery; Other.

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PACTR201501000981262
Not Applicable
Completed
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR201501000981262
Pure Global
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Improving Obstetrics Surgical Safety in KwaZulu-Natal
The impact of a modified WHO surgical safety checklist on maternal outcomes in an African setting.

Study Focus

Sponsor & Location

Dr Mergan Naidoo

Discovery Foundation

South Africa

Timeline & Enrollment

Not Applicable

Mar 01, 2013

Nov 30, 2013

Summary

The use of the WHO surgical safety checklist has become a controversial topic with investigators being divided on its use as a safety measure. Anaesthesia and surgery are associated with a 2.5 times greater risk of death in pregnant women in South Africa compared to having a normal vaginal delivery. The effect of a modified WHO surgical safety checklist for maternity care (MSSCL) on surgical outcomes and its use in low and middle income countries (LMIC) is unknown. The aim of the study was to reduce maternal surgical morbidity and mortality in KwaZulu-Natal (KZN) by implementing the MSSCL in maternity operating theatres (OT) in randomly selected district and regional hospitals in KZN. The objectives of the study were to:1. To establish a baseline of the current surgical safety culture in the public sector at 18 randomly selected hospitals in KZN.2. To establish the maternal and neonatal surgical outcomes at these hospitals.3. To implement the MSSCL in 50% (9) of the randomly selected hospitals, comprising 12 district and six regional hospitals.4. To evaluate the effect of the MSSCL on safety attitudes and surgical outcomes5. To compare the safety attitudes and surgical outcomes with hospitals which provide the current standard of care.6. To make recommendations to the KZN Department of Health on implementing, monitoring and evaluating surgical safety practices in the province to reduce the MMR.

ICD-10 Classifications

Other complications of obstetric surgery and procedures
Pregnancy, childbirth and the puerperium
Fetus and newborn affected by surgical procedure on mother
Other specified complications of labour and delivery
Personal history of complications of pregnancy, childbirth and the puerperium

Data Source

Pan Africa Clinical Trials Registry

PACTR201501000981262

Non-Device Trial