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CTRI Number  CTRI/2025/05/087067 [Registered on: 16/05/2025] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Pregnant female undergoing ceaserean section receiving I.V.Tranexamic acid 1g to see its effectiveness in reducing blood loss. 
Scientific Title of Study   Effect of preoperative use of intravenous tranexamic acid in reducing blood loss during caeserean section:Double blinded randomised controlled trial 
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 Venisree 
Designation  Junior resident OBGYN 
Affiliation  AIIMS JODHPUR 
Address  Department of Obstetrics and Gynecology ,OFFICE BUILDING ,AIIMS JODHPUR

Jodhpur
RAJASTHAN
342005
India 
Phone  7993632492  
Fax    
Email  venisreemudavath12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank shekhar  
Designation  Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of obstetrics and Gynecology ,AIIMS JODHPUR

Jodhpur
RAJASTHAN
342005
India 
Phone  7993632492  
Fax    
Email  longshanks28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venisree 
Designation  Junior resident 
Affiliation  AIIMS JODHPUR 
Address  Department of Obstetrics and Gynecology ,Office Building ,AIIMS JODHPUR

Jodhpur
RAJASTHAN
342005
India 
Phone  7993632492  
Fax    
Email  venisreemudavath12@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Venisree 
Address  Department of obstetrics and Gynecology,3rd floor college buiding ,aiims jodhpur,basni industrial area phase 2,pincode-342005 ,Rajasthan,India. 
Type of Sponsor  Other [] 
 
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 Venisree  Aiims jodhpur  Department of obstetrics and gynecology,office building,3rd floor.
Jodhpur
RAJASTHAN 		 7993632492

venisreemudavath12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1g IV tranexemic acid   Patient will receive One gram Tranexamic acid once through Intravenous route 20mins before skin incision in caeserean delivery 
Comparator Agent  normal saline  women will receive 100 ml of I.V normal saline 20mins once before skin incision as placebo 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  pregnant women above 18 years.
All consenting women undergoing caeserean section
 
 
ExclusionCriteria 
Details  Exclusion criteria
Non consenting patients
Prior history of Thromboembolism and bleeding disorders
Patients on Anticoagulants
Acute Fetal Distress
• Failed instrumental delivery
Exclusion criteria:
• Non consenting patients
• Prior history of Thromboembolism and bleeding disorders.
• Patients on Anticoagulants
• Acute Fetal Distress
• Failed instrumental delivery


 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
TO COMPARE THE DIFFERENCE IN INTRAOPERATIVE BLOOD LOSS DURING C SECTION AFTER PROPHYLACTIC ADMINISTRATION OF 1G IV TRANEXEMIC ACID   AFTER 10 MINS OF SKIN CLOSURE 
 
Secondary Outcome  
Outcome  TimePoints 
TO compare need of additional uterotonics drugs & measures
To compare side effects
TO compare hematocrit & hemoglobin drop after caeserean section
TO compare blood transfusion rates 		 During Ceaserean section if any additional uterotonics required.
after 24 hours Hematocrit & hemoglobin drop  
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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 2/ Phase 3 
Date of First Enrollment (India)   26/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Tranexamic acid (TXA) has been extensively studied for its efficacy and safety in reducing blood loss during and after caesarean section (CS), a procedure associated with increased risk of postpartum hemorrhage (PPH)Regarding safety, TXA administration was associated with a reduced risk of PPH and transfusions, with no significant increase in thromboembolic events . Minor side effects were more common in the TXA group than in the control group, but these were not clinically significant .In conclusion, prophylactic administration of TXA before caesarean section is an effective and safe intervention to reduce blood loss and associated complications. Its use is particularly advantageous in settings where blood conservation is critical and in patients at higher risk of bleeding.

 
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