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.: PACTR202008739887429 Date of Approval: 24/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study between oxytocin versus combination of tranexamic acid and ethsmyslate in reducing intra operative bleeding during abdominal myomectomy
Official scientific title Role of oxytocin versus tranexamic acid and ethsmyslate in reducing intra operative blood loss in myomectomy
Brief summary describing the background and objectives of the trial This study aims to compare the efficacy of oxytocin, tranexamic acid and ethsmyslate combination, and saline in controlling intra-operative bleeding during myomectomy. One hundred and eighty patients had been randomized in three groups each group contained 60 patients. The primary outcome is the amount of blood loss. The secondary outcomes are the need of blood and iron transfusion, duration of operation and hospital stay, need for hysterectomy, and postoperative fever
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 controlling bleeding after myomectomy
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/08/2020
Actual trial start date
Anticipated date of last follow up 20/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
Recruitment status Closed to recruitment,follow-up continuing
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 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 Oxytocin 30 IU of oxytocin in 500 ml normal saline will be administered during myomectomy during myomectomy 60 patients will take 30 IU of oxytocin in 500 ml normal saline during myomectomy 60
Experimental Group Tranexamic acid and Ethamsylate once before skin incision, 1 g tranexamic acid (2 ampoules of kapron 500 mg) and 250 mg Ethamsylate (1 ampoule of dicynone) once before skin incision once before skin incision, 1 g tranexamic acid (2 ampoules of kapron 500 mg) and 250 mg Ethamsylate (1 ampoule of dicynone) IV 60
Control Group saline 110 ml normal saline IV just before skin incision before skin incision 110 ml normal saline IV just before skin incision 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
premenopausal patients aged between 30 to 50 years old, five or less symptomatic uterine myomas, maximum diameter of the largest myoma is 6 cm, all myomas are subserous or intramural and uterine size less than 24 weeks pregnancy history of previous surgery, hypertension, cardiac and Pulmonary diseases, patients who have bleeding disorders, anemia (Hb< 10g %), chronic endocrine or metabolic diseases such as Diabetes, obesity (body mass index > 30 kg/m²) cases that require intraoperative conversion of myomectomy to hysterectomy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 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 04/11/2018 Quality Education Assurance Unit al Azhar Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Nasr City, Cairo Cairo 11651 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome amount of blood loss Complete blood count: 24 hours after surgery
Secondary Outcome the need of blood and iron transfusion during surgery and in 24 hours after surgery
Secondary Outcome duration of operation during operation
Secondary Outcome hospital stay after operation
Secondary Outcome need for hysterectomy intra-operative to control bleeding
Secondary Outcome postoperative fever during 24 hours after operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElGalaa Teaching Hospital El-Galaa St, Al Qalayah, Al Azbakeya, Cairo Governorate Cairo 11669 Egypt
El Hussein University Hospital El-Darb El-Ahmar, Cairo Governorate Cairo 11639 Egypt
Alazhar university hospitals of damietta address Kafr Elsad, new Damietta Damietta 34517 Egypt
Alazhar university hospitals of Assiut Al Walideyah Al Bahreyah, Asyut Second, Assiut Governorate Assiut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsayed Eldesouky Alagoza giza.3 nile abiad street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elgalaa teaching hospital El-Galaa St, Al Qalayah, Al Azbakeya, Cairo Governorate Cairo 11669 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Elsayed Eldesouky elsayedeldesouky@yahoo.com 201092934978 Alagoza giza.3 nile abiad street
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
Role Name Email Phone Street address
Public Enquiries Mohamed Abd ElGawad mohammed.mahmod87@gmail.com +201069401202 El toba street
City Postal code Country Position/Affiliation
Fayoum Egypt Medical student at faculty of medicine Fayoum university
Role Name Email Phone Street address
Principal Investigator Elsayed Eldesouky elsayedeldesouky@yahoo.com +201092934978 Alagoza giza.3 nile abiad street
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of obstetrics and gynecology faculty of medicine alazhar university Cairo
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 9 months and ending 36 months following article publication Researches who provide a methodologically sound proposal
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