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.: PACTR202507509436209 Date of Registration: 28/07/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized Controlled Trial Comparing Effectiveness and Safety of Carbetocin and Oxytocin in Preventing Postpartum Haemorrhage (COPP Study).
Official scientific title Randomized Controlled Trial Comparing Effectiveness and Safety of Carbetocin and Oxytocin in Preventing Postpartum Haemorrhage (COPP Study).
Brief summary describing the background and objectives of the trial Background PPH could be prevented if prophylactic uterotonics are administered during the third stage of labour, and by timely and appropriate management. Oxytocin is the first choice uterotonic drug recommended by the WHO. However, oxytocin is sensitive to heat exposure and must be transported and stored at 2-8 °C continuously. This represents a problem in low resource settings where the cold chain is difficult to access and maintain. Carbetocin, a long-acting analogue of oxytocin in its heat stable formulation, does not require cold chain transport and storage and can stay at room temperature for a long period of time (30°C for 3 years, 40°C for 6 months, 50°C for 3 months and 60°C for 1 month). Since carbetocin is a modified version of oxytocin, it should be expected that possible side effects might be similar. A number of studies have been conducted that challenged the superiority of oxytocin over carbetocin and the place of oxytocin as the first choice of uterotonics for prevention of PPH. However, comparative studies on this subject are few in low resource settings. This research into carbetocin effectiveness and safety in the prevention of PPH will help to provide important additional information to assist healthcare decision makers to ensure that women receive an effective uterotonic for prevention of PPH. AIM AND OBJECTIVES Aim: To compare the effectiveness and safety of carbetocin and oxytocin in preventing postpartum haemorrhage in active management of third stage of labour at the University of Ilorin teaching hospital.
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 01/09/2025
Actual trial start date 08/09/2025
Anticipated date of last follow up 02/03/2026
Actual Last follow-up date 09/03/2026
Anticipated target sample size (number of participants) 264
Actual target sample size (number of participants) 264
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 randomization using a randomization 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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment Group A carbetocin 100 mcg of carbetocin once slowly over 5 minutes Within a minute of delivery, treatment group A will receive 100 mcg carbetocin (slow bolus) 132
Control Group Treatment Group B oxytocin 10 IU of oxytocin once slowly over 5 minutes Within a minute of delivery, all patients will receive either 10 IU of oxytocin (slow bolus). 132 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting women above 18 years undergoing spontaneous vaginal delivery at term in a vertex presenting fetus a. grandmultiparity, b. anemia in pregnancy, c. antepartum haemorrhage in index pregnancy, d. asymptomatic placenta praevia, e. multiple pregnancy, f. co-existing uterine fibroid, g. polyhydramnious and h. previous scar Adult: 18 Year(s)-44 Year(s) 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 16/07/2025 University of Ilorin Teaching Hospital Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke - Ose, Ilorin . Ilorin PMB 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine incidence of PPH (blood loss > 500 ml following vaginal delivery) after 7th day postpartum
Secondary Outcome 1. Incidence of maternal side effects (nausea, vomiting, allergic reactions, ……..) 2. Incidence of retained placenta 3. Incidence of secondary postpartum haemorrhage 4. Incidence of maternal hypotension 5. Need for additional uterotonics 6. Change in haematocrit (pre delivery versus post delivery) 7. Need for blood transfusion 8. Need for surgical intervention (examination under anaethesia, B-lynch sutures, subtotal hysterectomy) 9. Length of hospital stay 10. Incidence of maternal death after 7th day postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba Road Oke - Ose Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ilorin TETFUND Institution Based Research 1 University Road Ilorin 240003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Ilorin TETFUND Institution Based Research 1 University Road, Ilorin 240003 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hadijat Olaide Raji laideraji1@yahoo.com +2348033940387 1 University Road
City Postal code Country Position/Affiliation
Ilorin 240003 Nigeria Professor University of Ilorin
Role Name Email Phone Street address
Public Enquiries Sadiya Musa Gwadabe mgsadiya@yahoo.com +2348022761652 1 University Road
City Postal code Country Position/Affiliation
Ilorin 240003 Nigeria Dr. University of Ilorin
Role Name Email Phone Street address
Scientific Enquiries Munirdeen A Ijaiya munirijaiya@yahoo.com +2348033801565 1 University Road
City Postal code Country Position/Affiliation
Ilorin 240003 Nigeria Professor University of Ilorin
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The patient would not be individually identified in the reports or publication that will arise from the study. Informed Consent Form,Study Protocol It will be share within 6 month of study publication. Researchers with a valid institutional affiliation and a legitimate research purpose which align with the original purpose of the study or contribute to the advancement of scientific knowledge and should demonstrate adequate measures to protect participant confidentiality and data security.
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