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.: PACTR202205750416982 Date of Registration: 18/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tranexamic acid versus etamsylate in reducing blood loss in patients with high risk of postpartum hemorrhage
Official scientific title Tranexamic acid versus etamsylate in reducing blood loss during normal vaginal delivery in patients with high risk of postpartum hemorrhage: Randomized controlled trial
Brief summary describing the background and objectives of the trial Postpartum hemorrhage remains a leading cause of maternal mortality and accounts for about one quarter of all maternal deaths worldwide. The aim of the current study is to investigate whether etamsylate may be a suitable alternative to tranexamic acid to reduce blood loss in normal delivery, as it has fewer side effects than 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 post partum hemorrhage
Purpose of the trial Prevention
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
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
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group tranexamic acid 1 ampoule once Group 1: include 60 women wil receive 1 g of tranexamic acid 60
Experimental Group Etamsylate 1 ampoule once Group 2: include 60 women will receive 1 g of etamsylate. 60
Control Group saline 10 ml saline once Group 3: include 60 women will receive 10 mL of normal saline. 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women who will give birth vaginally, full term of gestation age, susceptible for post-partum hemorrhage as: • History of pervious postpartum hemorrhage precipitate labour or instrumental delivery or prolonged induction of labour. •Anemic (hemoglobin between 8-10mg/dl), diabetic, macrosomic baby Women with thrombophilia, or coagulopathy cardiovascular, renal, or liver disorders; or contraindication to any drug used in the study protocol as (allergy to TXA or its excipients) Adult: 19 Year-44 Year 19 Year(s) 45 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 28/02/2022 Resaearch Ethics Committee at October 6 University
Ethics Committee Address
Street address City Postal code Country
elmhewar elmerkzi giza 12585 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) The amount of blood loss measured by using the difference between pre weighted towels and weightof towels soaked with blood ,towels were weighed 2h postpartum Two digital scales of the same brandwill be calibrated by the biomedical engineeringdepartment, one placed in October 6th university hospital and the other one placed in Ain shams Maternity hospital. 2) Complete blood picture (CBC) comparing hematocrit pre and postoperative and clinical data include blood pressure, pulse, andtemperature. 6 minutes
Secondary Outcome The percentage of cases that developed postpartumhemorrhage, the need for blood transfusion and theneed for further interventions to combat postpartum hemorrhage 1 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
october 6 hospital elmehwar elmarkzi giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 31 st elimam elshafey gamal abdel nasser gesr elswes cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor October 6th university and Ain shams Maternity hospital elmehwar elmarkzi giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf abolouz Ashraf.abolouz@gmail.com 01222376540 6 october
City Postal code Country Position/Affiliation
giza Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Haitham torky Haithamtorky@yahoo.com 01001230161 the 5th settlement
City Postal code Country Position/Affiliation
cairo Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries Ahmed gamal abadawie@hotmail.com 01001405558 6 october
City Postal code Country Position/Affiliation
giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries kareem labib Kareem_labib@yahoo.com 01005115380 cairo
City Postal code Country Position/Affiliation
cairo Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1) individual participant data will be available ( including data dictionaries) 2) all of the individual participant data collected during the trial after the deidentification. 3) study protocol , statistical analysis plan, informed consent and analytic code will be available. 4) data will be available immediately following publication and no end date. 5) available for anyone who wishes to access the data. 6) the analysis to achieve the aim in the approved proposal. 7) the mechanism of data will be available : proposal will be submitted after 36 months following article publication , after 36 months the data will be available in our university data warehouse, but without investigator support other than deposited metadata. Informed Consent Form data will be available immediately following publication and no end date. available for anyone who wishes to access the data.
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