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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: www.pactr.org

Trial no.: PACTR201306000536344 Date registered: 2013/04/25
TRIAL DESCRIPTION
Public title EFFECTS OF PROPOFOL VERSUS THIOPENTAL ON APGAR SCORES IN NEWBORNS AND PERI-OPERATIVE OUTCOMES OF WOMEN UNDERGOING CAESAREAN SECTION IN MULAGO HOSPITAL
Official scientific title EFFECTS OF PROPOFOL VERSUS THIOPENTAL ON APGAR SCORES IN NEWBORNS AND PERI-OPERATIVE OUTCOMES OF WOMEN UNDERGOING CAESAREAN SECTION IN MULAGO HOSPITAL; A RANDOMIZED CLINICAL TRIAL
Brief summary describing the background
and objectives of the trial
pregnant women will be randomised to receive either propofol or thiopentone as their induction agents. Apgar scores of their babies will be compared and peri-operative haemodynamic changes in the mother compared.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2013-05-06
Actual trial start date 2013-05-13
Anticipated date of last follow up 2013-11-04
Actual date of last follow up 2013-11-11
Anticipated target sample size (number of participants) 162   
Actual target sample size (number of participants) 162   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 simple randomisation using a randomisation codes created by a computer software program allocation was determined by the holder of the sequence who is situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group propofol 2mg/kg 5 minutes propofol used as induction agent 81 Active
Experimental group thiopental 5mg/kg 5 minutes thiopental used as an induction agent 81

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1.pregnant mothers scheduled for general anaesthesia 1. allergies to study drugs 2. refusal to consent 3. 18 Years 40 Years 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
No 2013/04/29 SOMREC
Ethics Committee Address
Street address City Postal code Country
makerere hill road kampala 7072, kampala Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome apgar scores 0 minute 5 minutes 10 minutes

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mulago national referal hospital mulago hill road kampala +256 Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
Belgian Development Agency (BTC) kololo kampala Uganda

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor janat tumukunde mulago hill road kampala 7051, mulago Uganda Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Andrew Kintu mulago hill road kampala 7051, mulago Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Janat Tumukunde janattumukunde@gmail.com +256 787 226515
Street address City Postal code Country Position / Affiliation
mulago hill road kampala 7051, mulago Uganda Doctor
Role Name Email Phone Fax
Public Enquiries Dr Arthur Kwizera kwizera.arthur@gmail.com +256 772897171
Street address City Postal code Country Position / Affiliation
mulago hill road kampala 7051, mulago Uganda Doctor
Role Name Email Phone Fax
Scientific Enquiries Dr kintu Andrew kintuug2012@gmail.com +256779229920
Street address City Postal code Country Position / Affiliation
mulago hill road kampala 7051, Mulago Uganda Doctor