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.: PACTR202001691971779 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Tranexamic acid in reducing blood loss during myomectomy in federal Medical Centre, Owerri: A randomised controlled trial
Official scientific title Effectiveness of Tranexamic acid in reducing blood loss during myomectomy in federal Medical Centre, Owerri: A randomised controlled trial
Brief summary describing the background and objectives of the trial Myomectomy remains a common surgical procedure in our environment for the management of symptomatic uterine fibroid. It is associated with significant perioperative blood loss. Differerent techniques are used during myomectomy tomanage blood loss with uterine tourniquet being the more popular technique in our environment. Tranexamic acid is an antifibrinolytic agent that has been used in surgical patients to reduce blood loss. Its use during myomectomy may prove to be an effective means of reducing blood loss. Aim of the study is to determine the effectiveness of intravenous Tranexamic acid in reducing blood loss during myomectomy in women undergoing myomectomy with the use of uterine tourniquet. Objectives: to compare the mean estimated intraoperative blood loss, determine the change in preoperative packed cell volume and to determine the number of patient needing blood transfusion
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 Uterine fibroid
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/11/2019
Actual trial start date
Anticipated date of last follow up 22/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous Tranexamic acid 1 gram Single dose Tranexamic acid will be given from a 10 milliliter syringe, intravenously over 10 minutes at a rate of 1 millilitre per minute, and completed at least 10 minutes before skin incision. All participants will have combined spinal epidural and entry into the peritoneal cavity will be by a midline or Pfannenstiel incision as decided by the surgeon. The uterus will be inspected and a tourniquet using size 18Fr Foley catheter will be applied around the isthmus of the uterus and held in place anteriorly by an hemostat. The incisions over the myoma will be done with a scalpel blade and the myomas enucleated by sharp and/or blunt dissection. Following removal of all myomas, the myoma beds will be closed in layers and the uterus reconstructed using polyglactin sutures. Uterine tourniquet will then be removed and additional hemostasis achieved by using figure of eight stitches. During the surgery, the operation field will be cleared of blood by the use of suction and laparotomy mops, and blood loss will be estimated using the gravimetric method while accounting for irrigation fluid. 30
Control Group Normal saline as placebo 10 milliliters Single dose Normal saline from a 10 milliliter syringe is given to the participants over 10 minutes duration at least 10 minutes before the commencement of surgery. Subsequent procedures are then similar to those of the participants in the experimental arm of the study. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Consenting women scheduled to have abdominal (laparotomy and ) myomectomy 2) uterine size of 16 weeks and above with multiple uterine fibroids 1) women with known allergy to Tranexamic acid 2) women with current and / or previous thromboembolic disease 3) women with bleeding disorders 4) women taking combine oral contraceptive pills 5) women who had received Gonadotrophin Releasing hormone analogue within three month of the proposed surgery 6) women who are receiving Tranexamic acid for menorrhagia within one month of surgery Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 60 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 28/02/2019 Research and Ethics Committee Federal Medical Centre Owerri
Ethics Committee Address
Street address City Postal code Country
Orlu Road Owerri Municipal 460212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Estimated intraoperative blood loss During surgery and at the end of surgery
Secondary Outcome Packed cell volume postoperative Second day post operation
Secondary Outcome Number of participants requiring blood transfusion During surgery till the 5th postoperative day
Secondary Outcome The number of units of whole blood transfused During surgery till the 5th postoperative day
Secondary Outcome Duration of sugery Time from the first uterine incision to the last stitch is placed on the uterus
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Federal Medical Centre Owerri Orlu Road Owerri Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Onwukwe Emeka Department of Obstetrics and Gynaecology Federal Medical Centre Owerri Owerri Municipal Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Onwukwe Emeka Department of Obstetrics and Gynaecology Federal Medical Centre Owerri Owerri municipal Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Nzeribe Emily Department of Obstetrics and gynaecology Federal medical centre Owerri Owerri municipal Nigeria
Dr Idih Ezinwanne Department of Obstetrics and gynaecology Federal Medical centre Owerri Owerri municipal Nigeria
Dr Ejelonu uchenna Department of Obstetrics and Gynaecology Federal Medical Centre Owerri Owerri municipal Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emeka Onwukwe jonwukwe18@gmail.com +2347033241904 Department of obstetrics and Gynaecology Federal Medical Centre Owerri
City Postal code Country Position/Affiliation
Owerri Municipal 460212 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Emeka Onwukwe jonwukwe18@gmail.com +2347033241904 Department of Obstetrics and Gynaecology Federal Medical Centre Owerri
City Postal code Country Position/Affiliation
Owerri Municipal 460212 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Onyedikachi Ezirim teddyezirim@yahoo.com +2347038715726 Department of Obstetrics and Gynaecology Federal Medical centre Owerri
City Postal code Country Position/Affiliation
Owerri Municipal Nigeria Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlies the result in the article to be published after the research will be available for sharing Study Protocol IPD will be available from 3 months after the published work with no ending Data will be available to anyone or group who requires access to it All type of data analysis is permitted Request for data should be forwarded via mail to the contact person with the purpose of the request stated
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