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.: PACTR201908793583382 Date of Approval: 06/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Carbetocin for the reduction of blood loss during myomectomy
Official scientific title Tranexamic Acid versus Carbetocin for Reduction of Blood loss during Abdominal Myomectomy
Brief summary describing the background and objectives of the trial Uterine fibroids are benign tumors of the uterus. They represent the most common benign tumor of the female genital tract during reproductive period. They present in about 70% of general population. Myomectomy although conservative, is associated with excessive blood loss. The aim of this study was to decrease blood loss during myomectomy using carbetocin in comparison with tranexamic acid.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied myomectomy surgery
Purpose of the trial Prevention
Anticipated trial start date 01/05/2016
Actual trial start date
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group tranexamic acid group 30 ml of sodium chloride with added 500 mg tranexamic acid at the time of skin incision control group 66 Active-Treatment of Control Group
Experimental Group carbetocin group 30 ml of sodium chloride with added 100 microgram carbetocin at the time of skin incision studyl group 66
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- age ranging from 18 to 50 years with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within last 12 months, - patients complaining of abnormal vaginal bleeding, chronic pelvic pain, pressure symptoms or reproductive disorders - pre-operative hemoglobin > 8g/dl. - post-menopausal women - patients previously treated with Depo-Lupron, Depo-Provera or oral contraceptive pills, - patients with known bleeding/clotting disorders, active liver, kidney or cardiovascular disease or receiving anticoagulant, NSAIDs or antiplatelet, - previous history of gynecological malignancy, - previous abdominal myomectomy or venous thromboembolism. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 17/04/2016 research ethics committee faculty of medicine suez canl univerity
Ethics Committee Address
Street address City Postal code Country
ring road ismailia, egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Studying the effect of tranexamic acid versus carbetocin on operative blood loss ( intra-and post operative ) and the needs of blood transfusion in women undergoing myomectomy. during the surgery and 48 hours after
Secondary Outcome the need for blood transfusion, patients hemoglobin level after the operation during the surgery and 48 hours after
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university faculty of medicine ring road, kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sherehan magdi elkeplawy ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty pf medicine suez canal university ring road, kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
omima tharwat taha ring road kilo 4.5 ismailia Egypt
Zakia Mahdy abolill ring road kilo 4.5 ismailia Egypt
mariam lotfy mohamed ring road kilo 4.5 ismailia Egypt
khaled Ahmed Atwa ring road kilo 4.5 ismailia Egypt
sherehan magdi elkeplawy ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zakia abolill zakiamahdyabolill@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 002001223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes through the research and after approval of our ethical committee Study Protocol after publishing the trial after approval of our ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.dropbox.com/s/kigmb1zem91n2d3/sherehan%20protocol-1.docx?dl=0 Yes Total blood loss was significantly lower in the Carbetocin group (399.27 ± 28.94 ml) than the tranexamic acid group (535.15 ± 80.30 ml) (p <0.001). Intra-operative blood loss was significantly lower in the Carbetocin group (371.39 ± 27.54 ml) than the tranexamic acid group (478.48 ± 60.4 ml) (p <0.001). Post-operative blood loss was significantly lower in the Carbetocin group (27.88 ± 32.32 ml) than the tranexamic acid group (56.67 ± 53.13 ml) (p 0.001). 03/08/2019 03/08/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/kigmb1zem91n2d3/sherehan%20protocol-1.docx?dl=0
Changes to trial information