Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501000981262 Date of Registration: 23/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Improving Obstetrics Surgical Safety in KwaZulu-Natal
Official scientific title The impact of a modified WHO surgical safety checklist on maternal outcomes in an African setting.
Brief summary describing the background and objectives of the trial 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 outcomes 5. 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Maternal surgical morbidity and mortality,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2013
Actual trial start date 01/03/2013
Anticipated date of last follow up 30/11/2013
Actual Last follow-up date 30/11/2013
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 26985
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
BE 216/2012 HRKM 146/12
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Sites were stratified and then a simple randomisation was done using Excel Each site within a strata was allocated a number Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Implementation of a modified WHO surgical safety checklist for maternity care Every patient undergoing maternal surgery 6 months The operative team i.e. surgeon, anaesthetist and scrub nurse had to all use the checklist with each patient 11416
Control Group Current standard care 9months Nil 15569 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All hospitals providing obstetrical surgical care in KwaZulu-Natal Hospital managers and staff who agreed to participate in the study Tertiary and central hospitals 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Biomedical Research Ethics Committee of the University of KwaZulu-Natal
Ethics Committee Address
Street address City Postal code Country
Govan Mbeki Research Centre, Room N40 University of KwaZulu-Natal Westville Campus 4000 Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal mortality March 2013 (pre-intervention) April 2013 (pre-intervention) May 2013 (pre-intervention) June 2013 July 2013 August 2013 September 2013 October 2013 November 2013
Secondary Outcome Maternal surgical morbidity March 2013 (pre-intervention) April 2013 (pre-intervention) May 2013 (pre-intervention) June 2013 July 2013 August 2013 September 2013 October 2013 November 2013
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bethesda Hospital Ubombo sub-district, Umkhanyakude Ubombo 3970 South Africa
Church of Scotland Hospital Main Dundee Road, Tugela Ferry, 3010 Tugela Ferry 3010 South Africa
Edendale Hospital Lot 89, Selby Msimang Road, Plessislaer, Pietermaritzburg Pietermaritzburg 3216 South Africa
Eshowe Hospital 40 Kangella Street, Eshowe 3815 Eshowe 3815 South Africa
GJ Crookes Hospital Hospital road, Scottburgh Scottsburgh 4180 South Africa
Hlabisa Hospital 60 Saunders Street Hlabisa 3937 Hlabisa 3937 South Africa
LOWER UMFOLOZI REGIONAL WAR MEMORIAL HOSPITAL 29 Union Street Empangeni 3380 Empangeni 3380 South Africa
MAHATMA GANDHI MEMORIAL HOSPITAL 100 Phoenix Highway, Phoenix Durban 4300 South Africa
Montebello Hospital P614 Noordsberg Road, Dalton Dalton 3236 South Africa
Murchison Hospital Main Harding and Kokstad road, Port Shepstone, Port Shepstone 4240 South Africa
Newcastle Hospital 4 Hospital street Newcastle Newcastle 2940 South Africa
NIEMEYER MEMORIAL HOSPITAL Kantoor Street Utrecht Utrecht 2980 South Africa
Nkonjeni hospital Ekudubekeni Reserve, Mahlabatini, Mahlabathini 3865 South Africa
Northdale Hospital Chota Motola road Northdale Pietermaritzburg Pietermaritzburg 3200 South Africa
PRINCE MSHIYENI MEMORIAL HOSPITAL Mangosuthu Highway, Umlazi Durban 4060 South Africa
Stanger hospital Corner of King Shaka and Patterson Street, Stanger Stanger 4450 South Africa
Wentworth Hospital Sidmouth Avenue Wentworth Durban 4026 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Discovery Foundation Block B Metropolitan Office Park 8 Hillside Road Parktown Braamfontein 2017 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mergan Naidoo Room 225F, George Campbell Building, Howard College, Glenwood Durban 4001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Jagidesa Moodley Women's Health & HIV Research Unit Room 335, 3rd floor DDMRI Building Nelson R Mandela School of Medicine 719 Umbilo Road Durban 4001 South Africa
Prof Premjith Gathiram Room 225F, George Campbell Building, Howard College, Glenwood Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mergan Naidoo naidoom@ukzn.ac.za +27835005334 Room 225F, George Campbell Building, Howard College, Durban
City Postal code Country Position/Affiliation
Durban 4001 South Africa UKZN
Role Name Email Phone Street address
Public Enquiries Mergan Naidoo naidoom@ukzn.ac.za +27835005334 Room 225F, George Campbell Building, Howard College, Durban
City Postal code Country Position/Affiliation
Durban 4001 South Africa UKZN
Role Name Email Phone Street address
Scientific Enquiries Mergan Naidoo naidoom@ukzn.ac.za +27835005334 Room 225F, George Campbell Building, Howard College, Durban
City Postal code Country Position/Affiliation
Durban 4001 South Africa UKZN
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information