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.: PACTR202403873496250 Date of Registration: 01/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of oral clonidine pre-medication on intra-operative blood loss during caesarean section under sub-arachnoid block
Official scientific title Effects of Oral Clonidine Pre-medication on Intra-Operative Blood Loss during Caesarean Section under Sub-Arachnoid Block in Federal Teaching Hospital Abakaliki
Brief summary describing the background and objectives of the trial Caesarean section is known to be associated with several complications, of which excessive intra-operative bleeding stands out. Though several methods have been used to limit intra-operative haemorrhage during caesarean section, these are not without their limitations. Clonidine, an oral anti-hypertensive drug, has been suggested as being able to significantly reduce intra-operative blood loss. The objective of the study is to assess the effects of oral clonidine premedication on the intra-operative blood loss, maternal haemodynamic stability and neonatal outcome during caesarean sections under subarachnoid block (SAB).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/03/2018
Actual trial start date 02/04/2018
Anticipated date of last follow up 09/11/2018
Actual Last follow-up date 05/11/2018
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 158
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clonidine grouup 0.2mg stat 90 minutes before surgery Normotensive and Hypertensive patients received 0.2mg of oral clonidine 80
Control Group Placebo group 100mg of Vitamin C single dose Each normotensive and hypertensive patient in this group received a single dose of 100mg of Vitamine C 90 minutes before the surgery 78 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Normotensive and mild to moderate hypertensive (controlled) pregnant women aged 18 to 45 years who were scheduled for elective caesarean section under SAB at the study centre Those who consented to participate in the study.  Patients below age 18 and above age 45years.  Grandmultiparous women (parity greater or equal to 5).  Patients with complications of pregnancy such as: placenta praevia, Abruptio placentae, pre-eclampsia with BP ≥ 160/110mmHg, Eclampsia, pregnancy-induced hypertension or chronic hypertension in pregnancy with BP ≥ 160/110mmHg.  Emergency Caesarean sections  Patients with Cardiovascular /Respiratory diseases  Renal/hepatic disease patients  Multiple gestations.  Patients that took antihypertensive <24 hours before surgery.  History of allergy to the study drug.  Patients with height less or equal to 1.0m.  Patients with previous caesarean section(s). Adult: 19 Year-44 Year 19 Year(s) 44 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 26/03/2018 Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
No 1 AEFUTHA Abakaliki Abakaliki 480101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Volume of intra-operative blood loss 2 minutes after surgery and 24 hours after the surgery
Secondary Outcome Haemodynamic stability of patients, neonatal APGAR Scores, incidence of side effects like nausea, vomiting, shivering, sedation, hypotension etc. and the need for rescue analgesia Every 15 Minutes intra-operatively, 1 minute and 5 minutes after delivery of the baby, 15 minutes after sugery and within 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki No 1 AEFUTHA Road Abakaliki 480101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
None Plot 108 Road Nkaliki GRA Abakaliki 480101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Plot 108 Nkaliki GRA, Abakaliki Abakalliki 480101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr John Egede Department of Obstetrics and Gynaecology AEFUTHA Abakaliki 480101 Nigeria
Dr Joshua Adeniyi Adebayo Department of Obstetrics and Gynaecology, AEFUTHA Abakaliki 480101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cletus Uchechukwu Onwe onwecletus@yahoo.com +2348033135639 Department of Anaesthesia, AEFUTHA
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant Department of Anaesthesia Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
Role Name Email Phone Street address
Public Enquiries John Okafor Egede egedejohno@gmail.com +2348037797950 Plot 108 Nkaliki GRA, Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant Department of Obstetrics and Gynaecology Alex Ekwueme Federal University teaching Hospital Abakaliki
Role Name Email Phone Street address
Scientific Enquiries John Okafor Egede egedejohno@gmail.com +2348037797950 Plot 108 Nkaliki GRA, Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant Department of Obstetrics and Gynaecology Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Result is ready and we are ready to share Access criteria is open. Any individual or organization interested in the result can access it by a written request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 11/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information