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.: PACTR201403000636418 Date of Approval: 05/09/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A TRIAL COMPARING PROPHYLACTIC PHENYLEPRINE FIXED DOSE VERSES A WEIGHT ADJUSTED DOSE IN REDUCING HYPOTENSION FOLLOWING SPINAL ANAESTHESIA FOR CAESERE
Official scientific title A RANDOMIZED CONTROL TRIAL COMPARING WEIGHT ADJUSTED DOSE VERSUS FIXED DOSE PROPHYLACTIC PHENYLEPRINE INFUSION ON MAINTAINING SYSTOLIC BLOOD PRESSURE DURING CAESEREAN SECTION UNDER SPINAL ANAESTHESIA.
Brief summary describing the background and objectives of the trial A prophylactic phenylephrine infusion combined with a fluid co-load is proven to be an effective and safe method of maintaining maternal hemodynamic stability. Objective Compare the incidence of hypotension between women undergoing elective caesarean section assigned to receive prophylactic phenylephrine infusion at a fixed dose of 37.5micrograms/minute versus a weight adjusted dose of 0.5micrograms/kilogram/minute.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Hypotension following spinal anaesthesia for caeserean section.,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/07/2013
Actual trial start date 10/09/2013
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date 31/12/2013
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 130
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group prophylactic phenyleprine fixed dose infusion infusion at 37micrograms/min from completion of the spinal tp delivery of the baby phenyleprine bolus if MAP reduces by 20% from baseline and infusion stopped with increase of MAP above 20% of baseline 53
Experimental Group weight adjusted dose 0.5micrograms/kg/min from completion of spinal till delivery of the baby the prophylactic phenylephrine infusion will be started from completion of the spinal till delivery of the baby, and blood pressure recirded every 2mins. a fall in blood pressure at 20% from the baseline will be considered as hypotension and 50micrograms bolus of phenyleprine will be given 53
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA I and II patients over 18years scheduled for non-urgent caesarean delivery. 1. Patient refusal 2. Patients with contraindications to neuraxial anaesthesia a. Puncture site infection b. Hypovolemic shock c. Coagulopathy d. Sepsis 3. Patient involved in any other clinical studies 4. Women scheduled for emergency c\s 5. Type 1 DM 6. HPTN/Cardiac disease 18 Year(s) 45 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 03/10/2013 aGAHKHAN UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
3rd Parklands avenue NAIROBI 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compare the incidence of hypotension between the two study groups Following spinal anaesthesia a drop of the mean arterial pressure of 20% from baseline is considered a hypotensive episode.
Secondary Outcome Porportion of bradycardia and reactive hypertension between the two study groups from completion of the spinal till delivery of the baby
Secondary Outcome Number of physician interventions between the two study groups From competion of spinal till delivery of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue P.O Box 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan university Research committee 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan university Research committee 3rd Parklands Avenue P.O Box 30270 Nairobi 00100 Kenya University
Primary Sponsor Agah Khan University research comittee 3rd Parklands Avenue P.O Box 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
DR SAMINAR MIR 3rd Parklands Avenue P.O Box 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator LUCY MWAURA lucy.mwaura@aku.edu +254720422075 3rd parklands avenue P.O BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya resident doctor
Role Name Email Phone Street address
Public Enquiries Samina Mir samina.mir@aku.edu +254726720473 3rd parklands avenue P.O BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Obstetric Anaesthesiologist
Role Name Email Phone Street address
Scientific Enquiries Vitalis Mungayi vitalis.Mungayi@aku.edu +254733635554 3rd parklands avenue P.O BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Anaesthesiologist
REPORTING
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