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.: PACTR202506916530208 Date of Approval: 20/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the effect of tranexamic acid injection on the estimated blood loss among anemic women undergoing delivery
Official scientific title Evaluation of the effect of tranexamic acid injection on the estimated blood loss among anemic women undergoing delivery
Brief summary describing the background and objectives of the trial Tranexamic acid, given within 3 h of birth, reduces bleeding deaths in women with postpartum haemorrhage. We examined whether giving tranexamic acid shortly after birth would affect the average blood loss among women with moderate or severe anaemia. Objective: To estimate the average blood loss after tranexamic acid injection among anemic women giving birth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/06/2025
Actual trial start date
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants)
Recruitment status Active, not 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
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo group 10 ml saline infused IV within 15 min after delivery of the baby placebo will be given within 15 min after delivery of the baby, blood loss will be evaluated after 24 hours of delivery placebo 270 Placebo
Experimental Group tranexamic acid group 1 gm tranexamic acid (Kapron ampules 500mg/5ml) within 15 minutes after delivery of the baby tranexamic acid will be given within 15 minutes after delivery of the baby blood loss will be evaluated after 24 hours of delivery tranexamic acid group 270
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) women aged 18-45 years, b) women delivering vaginally or by cesarean section, c) women diagnosed with anemia (Hb < 10.5 g/dl) d) singleton pregnancy with cephalic presentation, e) BMI < 40kg/m2, a) participants refusing to participate in the study, b) anemia due to blood disease as thalassemia and sickle cell anemia, c) women on anticoagulant therapy, d) preterm birth, e) allergy to TXA, f) abnormal placentation as placenta previa- accreta spectrum -defined as abnormal implantation of the placenta or invasion to the lower uterine segment, g) placental abruption, h) pregnancy-related complications as severe preeclampsia, Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 29/04/2025 research ethics committee of faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road, kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the amount of peripartum blood loss in both groups after 24 hours of delivery
Secondary Outcome the incidence of PPH defined as blood loss ≥ 1000 ml for women having CS and ≥ 500 ml for women having vaginal delivery, need for surgical intervention (hysterectomy, laparotomy, embolization, uterine compression sutures, and arterial ligation) in cases with PPH, and need for blood transfusion. after 24 hours of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university ring road, kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
omima tharwat ring road, kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university ring road, kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
omima tharwat ring road, kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator omima taha omimatharwat@yahoo.com +2001223423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university faculty of medicine
Role Name Email Phone Street address
Public Enquiries islam Albiadi eslamalbayadi@gmail.com +2001223666764 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 +2001223423685 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 data sharing is possible after reasonable request from the corresponding author. data sharing would include the raw material if required Study Protocol after completion of the study after reasonable request from the corresponding author
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/06/2025 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/06/2025 PACTR Admin TRUE, research ethics committee of faculty of medicine suez canal university, ring road, kilo 4.5, ismailia, 41522, Egypt, , 28 Apr 2025, +203200789, rec@med.suez.edu.eg, 34852_32012_4737.pdf TRUE, research ethics committee of faculty of medicine suez canal university, ring road, kilo 4.5, ismailia, 41522, Egypt, , 29 Apr 2025, +203200789, rec@med.suez.edu.eg, 34852_32012_4737.pdf