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.: PACTR201312000577386 Date of Approval: 28/06/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title dexamethasone and spinal anaesthesia
Official scientific title Efficacy and safety of dexamethasone in prevention of intra operative nausea, vomiting and hypotension in obstetrics
Brief summary describing the background and objectives of the trial Hypotension is the most common and feared complication of spinal anaesthesia among parturients undergoing caesarean section which may compromise the well being of both the mother and the foetus(Reid et al,1995).To compare incidence of intra-operative hypotension, nausea and vomiting in parturients recieving a preoperative bolus of dexamethasone with the placebo under spinal anesthesia in mulago hospital. To compare the incidence adverse events in women recieving a preoperative bolus of dexamethasone with the placebo under spinal anaesthesia in mulago hospital
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,intraoperative nausea, vomiting and hypotension,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/08/2013
Actual trial start date 30/09/2013
Anticipated date of last follow up 30/10/2013
Actual Last follow-up date 30/11/2013
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
Recruitment status Not yet recruiting
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
Randomised simple randomisation by computer program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexamethasone 8mg , within 1 hour preoperatively 1minute dexamethasone 90
Control Group placebo 2mls of placebo within 1 hour preoperatively 1 minute normal saline 90 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Women 18-40 years old undergoing caesarean sections under spinal anaesthesia and having Consented to participate in the study. Emancipated minors. ASA 1and ASA 11 Patient¿s refusal to consent Hypertension History of allergy to dexamethasone Severe systemic infections History of active GI ulceration History dexamethasone treatment in the last 24 hours ASA 111 and above 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 05/06/2013 Makerere University college of health sciences school of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
KAMPALA 7021 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intraoperative hypotension intraoperative nausea vomiting
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mulago hospital kamokya road Kampala p.o box 7021
FUNDING SOURCES
Name of source Street address City Postal code Country
kojjo Charles,self kamokya road kampala 7021 KAMAPLA Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MaCHS kamapala Uganda University
Primary Sponsor kojjo Charles kamokya road kampala 7021 KAMAPLA Uganda University
COLLABORATORS
Name Street address City Postal code Country
department of obstetric MaKCHS kamapala 7021 KAMAPLA Uganda
Kwizera Arthur MaKCHS kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Kojjo charleskojjo@yahoo.com +256779142269
City Postal code Country Position/Affiliation
kamapala Uganda resident
Role Name Email Phone Street address
Public Enquiries Andrew Kintu andrewkintu@gmail.com +256702439864
City Postal code Country Position/Affiliation
kamapala Uganda lecturer
Role Name Email Phone Street address
Scientific Enquiries Arthur Kwizera arthurkwizera@gmail.com +256772897171
City Postal code Country Position/Affiliation
kamapala Uganda anaesthesiologist
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