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CTRI Number  CTRI/2025/08/092779 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see if giving tranexamic acid before caesarean section helps reduce blood loss in women. 
Scientific Title of Study   To Evaluate the Role of Prophylactic Use of Tranexamic Acid in Reducing Blood Loss during Caesarean Section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chirag Sharma 
Designation  Junior Resident 
Affiliation  Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P 
Address  Room No 404, Department of Obstetrics and Gynaecology, Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P

Hamirpur
HIMACHAL PRADESH
177001
India 
Phone  8629834052  
Fax    
Email  chirag.chirag24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Sharma 
Designation  Associate Professor 
Affiliation  Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P 
Address  Room No 402, Department of Obstetrics and Gynaecology, Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P

Hamirpur
HIMACHAL PRADESH
177001
India 
Phone  981608888  
Fax    
Email  anuragshruti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chirag Sharma 
Designation  Junior Resident 
Affiliation  Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P 
Address  Room No 404, Department of Obstetrics and Gynaecology, Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P

Hamirpur
HIMACHAL PRADESH
177001
India 
Phone  8629834052  
Fax    
Email  chirag.chirag24@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Radhakrishnan Government Medical College and Hospital Hamirpur HP 
Address  Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, Himachal Pradesh, India, Pincode 177001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chirag Sharma  Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, HP  Room No 404, Department of Obstetrics and Gynaecology, Dr Radhakrishnan Government Medical. College and Hospital, Hamirpur, HP, 177001
Hamirpur
HIMACHAL PRADESH 		 8629834052

chirag.chirag24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr Radhakrishnan Government Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  10 mL of Normal Saline  10 mL of Normal Saline in 100 mL of Normal Saline iv infusion Duration of study 6 months 
Intervention  Tranexamic Acid   10 mL (1 gram) of Tranexamic Acid in 100 mL Saline iv infusion Duration of study 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Singleton, term pregnancy
Informed consent provided 
 
ExclusionCriteria 
Details  Multiple pregnancy
Pre-eclampsia
Macrosomia
Polyhydramnios
Fibroid complicating pregnancy
Placental abnormalities (e.g., placenta previa, abruptio placentae, placenta
accreta/increta/percreta)
History of bleeding disorders
Allergy to tranexamic acid
Systemic complications involving the heart, liver, or kidneys
Prolonged or obstructed labour
Parity greater than  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total blood loss (in mL) measured intraoperatively and up to 2 hours postoperatively  Total blood loss (in mL) measured intraoperatively and up to 2 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Change in haemoglobin and haematocrit levels  24 hours post surgery 
Requirement for blood transfusion  24 hours 
Use of additional uterotonic agents  24 hours 
Adverse effects related to tranexamic acid  42 days 
Postoperative complications  42 days 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [chirag.chirag24@gmail.com].

  6. For how long will this data be available start date provided 04-08-2025 and end date provided 04-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Caesarean section routinely entails greater blood loss than vaginal delivery, placing women at risk of

perioperative anaemia, transfusion and its complications. Standard uterotonic protocols (oxytocin ±

additional agents) do not fully prevent bleeding in all cases. Tranexamic acid (TXA) is a cost-effective

antifibrinolytic that stabilises clot formation.

This double-blind, randomised, placebo-controlled trial will evaluate whether a single 1 g IV dose given

pre-operatively reduces intraoperative and early postpartum blood loss in women undergoing elective

or emergency caesarean section.

Primary endpoints are measured blood loss (gravimetric + suction canister) and change in haemoglobin

and haematocrit at 24 hours. Secondary endpoints include transfusion requirement, additional

uterotonic use and any TXA-related adverse events.

We hypothesise that TXA will significantly decrease perioperative bleeding and transfusion needs

without increasing complications, supporting its routine prophylactic use in caesarean practice.


 
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