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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201306000536344 Date of Registration: 25/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Apgar scores of babies,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/05/2013
Actual trial start date 13/05/2013
Anticipated date of last follow up 04/11/2013
Actual Last follow-up date 11/11/2013
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants) 162
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Outcome Assessors,Participants
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-Treatment of Control Group
Experimental Group thiopental 5mg/kg 5 minutes thiopental used as an induction agent 81
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.pregnant mothers scheduled for general anaesthesia 1. allergies to study drugs 2. refusal to consent 3. 18 Year(s) 40 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 29/04/2013 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 Street address
Principal Investigator Janat Tumukunde janattumukunde@gmail.com +256 787 226515 mulago hill road
City Postal code Country Position/Affiliation
kampala 7051, mulago Uganda Doctor
Role Name Email Phone Street address
Public Enquiries Arthur Kwizera kwizera.arthur@gmail.com +256 772897171 mulago hill road
City Postal code Country Position/Affiliation
kampala 7051, mulago Uganda Doctor
Role Name Email Phone Street address
Scientific Enquiries kintu Andrew kintuug2012@gmail.com +256779229920 mulago hill road
City Postal code Country Position/Affiliation
kampala 7051, Mulago Uganda Doctor
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