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.: PACTR202201739991276 Date of Approval: 14/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF THE EFFECTIVENESS OF CARBETOCIN AND OXYTOCIN IN DECREASING POSTOPERATIVE BLOOD LOSS AMONG WOMEN UNDERGOING CAESAREAN SECTION IN WARRI, DELTA STATE, NIGERIA: A RANDOMIZED CONTROLLED TRIAL.
Official scientific title COMPARISON OF THE EFFECTIVENESS OF CARBETOCIN AND OXYTOCIN IN DECREASING POSTOPERATIVE BLOOD LOSS AMONG WOMEN UNDERGOING CAESAREAN SECTION IN WARRI, DELTA STATE, NIGERIA: A RANDOMIZED CONTROLLED TRIAL.
Brief summary describing the background and objectives of the trial BACKGROUND Postpartum haemorrhage is the most common cause of maternal mortality globally. Oxytocin, the recommended drug for the prevention of postpartum haemorrhage requires cold chain storage, has a short half-life and has to be given as a continuous infusion after caesarean delivery. A heat-stable, long-acting alternative with similar efficacy and safety is strongly desired. AIMS AND OBJECTIVES The study aims to compare the effectiveness of Carbetocin with that of Oxytocin in reducing blood loss after caesarean delivery. The study objectives will be to compare postoperative blood loss, need for additional uterotonic, postpartum haemorrhage more than 1000mls, haemoglobin concentration change, need for blood transfusion, and side effects among patients that receive Carbetocin and those that receive Oxytocin.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Carbetocin arm Intravenous 100 micrograms of Carbetocin followed by 4-hour infusion of 500mls of normal saline. 4 hours Intravenous 100 micrograms of Carbetocin followed by 4-hour infusion of 500mls of normal saline. 75
Control Group Oxytocin arm Intravenous 10 IU of Oxytocin followed by a 4-hour infusion of 20 IU of oxytocin in 500mls of normal saline. 4 hours Intravenous 10 IU of Oxytocin followed by a 4-hour infusion of 20 IU of oxytocin in 500mls of normal saline. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women providing consent Term pregnancy Live singleton pregnancy Parity less than 5 History of atonic postpartum haemorrhage Uterine fibroids Multiple gestations Placenta praevia Grand multiparity Use of anticoagulant Use of tocolytics History of coagulopathy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 07/09/2020 Central Hospital Warri Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
No. 1 Mabiaku Street, Off Warri-Sapele road, GRA, Warri. Warri PMB 1004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative bloodloss After caesarean section and 4 hours postoperation.
Secondary Outcome PPH greater than 1000mls Postoperation
Secondary Outcome Use of additional uterotonic postoperation
Secondary Outcome Blood transfusion postoperation
Secondary Outcome Adverse effects postoperation
Secondary Outcome Haemoglobin change postoperation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Hospital Warri No. 1 Mabiaku road, Off Warri-Sapele road, GRA, Warri. Warri Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OKWUCHUKWU ONYEOWUZONI No. 1 Mabiaku Street, off Warri-Sapele road, GRA, Warri. Warri Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OKWUCHUKWU ONYEOWUZONI NO 1 MABIAKU STREET, OFF WARRI-SAPELE ROAD, GRA, WARRI. WARRI Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 NO. 1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA, WARRI.
City Postal code Country Position/Affiliation
WARRI. Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 NO. 1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA, WARRI.
City Postal code Country Position/Affiliation
WARRI. Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 NO. 1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA, WARRI.
City Postal code Country Position/Affiliation
WARRI. Nigeria SENIOR REGISTRAR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data summary results. All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Study Protocol January 2023 to June 2023. Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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