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.: PACTR202204640411588 Date of Approval: 22/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF TWO DOSES OF CARBETOCIN WITH OXYTOCIN FOR THE PREVENTION OF POSTPARTUM BLEEDING
Official scientific title COMPARISON OF TWO DOSES OF CARBETOCIN WITH OXYTOCIN FOR THE PREVENTION OF POSTPARTUM HAEMORRHAGE: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial BACKGROUND Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide, with uterine atony being its most common aetiology. Prophylactic administration of uterotonic drugs is recommended to reduce blood loss and prevent PPH. OBJECTIVE To compare the efficacy of 50μ and 100μg of carbetocin with standard 10IU of oxytocin for the prevention of PPH in women following delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CONCERT
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum haemorrhage
Purpose of the trial Prevention
Anticipated trial start date 01/05/2022
Actual trial start date
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 321
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://eu.docworkspace.com/d/sIKf-styXAZmn4JIG
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 50microgram of carbetocin stat Given over one minute Patients allocated to this group will be healthy pregnant women at term receiving 50 microgram of intravenous carbetocin following delivery by vaginal route or caesarean section 107
Experimental Group Group 2 100 microgram of carbetocin stat Given over one minute Patients allocated to this group will be healthy pregnant women at term receiving 100 microgram of intravenous carbetocin following delivery by vaginal route or caesarean section 107
Control Group Group 3 10 international units of oxytocin stat Given over one minute Patients allocated to this group will be healthy pregnant women at term receiving 10 international units of intravenous oxytocin following delivery by vaginal route or caesarean section 107 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy pregnant women at term Women with history of, or being treated for bleeding disorder Women with intrauterine fetal demise Women with antepartum haemorrhage Women requiring general anaesthesia Adult: 19 Year-44 Year 18 Year(s) 49 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 04/02/2022 UIUCH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
College of medicine, University of Ibadan Ibadan 200005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Uterine contractility by palpation (as recommended by WHO)13, at two and five minutes by the attending accoucheur after intravenous administration of the study drug. This is because of the onset of action of carbetocin at 2 minutes with contractions lasting for about 6 minutes following its administration2. - Estimated blood loss after intravenous administration of the study drug. At 2 and 5 minutes following administration of study drug
Secondary Outcome -The use of additional uterotonic agents, -The need for blood transfusion. -The need for additional surgical interventions such as hysterectomy -The occurrence of side effects (hypo/hypertension, brady/tachycardia, nausea/vomiting, flushing, headache, others) following the administration of the study drug. Within 24hours of administration of study drug
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Ibadan Queen Elizabeth road, Oritamefa, Ibadan Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Rasheedat Balogun Department of obstetrics and gynaecology, UCH Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rasheedat Balogun University College Hospital Ibadan Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Adeyinka Ishola Department of Pharmacy, UCH Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasheedat Balogun lolea1310@yahoo.com +2348020717726 Department of obstetrics and gynaecology, UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar OBGYN
Role Name Email Phone Street address
Public Enquiries Rasheedat Balogun lolea1310@yahoo.com +2348020717726 Department of obstetrics and gynaecology UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar OBGYN
Role Name Email Phone Street address
Scientific Enquiries Imran MorhasonBello imranmorhasonbello@gmail.com +2348034784402 Department of obstetrics and gynaecology UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Honorary Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: “Data obtained through this study may be provided to qualified researchers with academic interest in maternal mortality. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact lolea1310@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://eu.docworkspace.com/d/sIKf-styXAZmn4JIG 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