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CTRI Number  CTRI/2021/03/031690 [Registered on: 03/03/2021] Trial Registered Prospectively
Last Modified On: 02/03/2021
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   A study to assess the role of Tranexamic acid in reducing blood loss in Cesarean Sections in women at high risk for Postpartum Hemorrhage 
Scientific Title of Study   To assess the role of Tranexamic acid in reducing the blood loss in women at high risk for Postpartum Hemorrhage undergoing Cesarean Section - A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bethany Grace Neumann 
Designation  Post Graduate Student 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Obstetrics and Gynaecology Jawaharlal Nehru Medical College JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7829567851  
Fax    
Email  beth.grace10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MC Metgud 
Designation  Professor, Department of Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynaecology Jawaharlal Nehru Medical College JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bethany Grace Neumann 
Designation  Post Graduate Student 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Obstetrics and Gynaecology KAHERs Jawaharlal Nehru Medical College JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7829567851  
Fax    
Email  beth.grace10@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, KLE University 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College KLE University 
Address  KAHERs Jawaharlal Nehru Medical College JNMC Campus Nehru Nagar Belagavi 
Type of Sponsor  Research institution and hospital 
 
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 Bethany Grace Neumann  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi  Department of Obstetrics and Gynaecology Jawaharlal Nehru Medical College Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA 
7829567851

beth.grace10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee on Human Subjects Research  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 
Comparator Agent  Normal Saline  After randomisation, Control group (Group B) will receive 10ml of Normal Saline NaCl 0.9% iv at least 10 minutes prior to skin incision in cesarean sections. After delivery of the baby, 10 units Oxytocin im and iv will be administered according to standard care. 
Intervention  Tranexamic acid  After randomisation, Treatment group (Group A) will receive Inj Tranexamic acid 1g (10ml) slow iv, over 2 minutes at least 10 minutes prior to skin incision in cesarean sections. After delivery of the baby, 10 units Oxytocin im and iv will be administered according to standard care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women at gestational age of 34 weeks or more, who are to undergo elective or emergency caesarean delivery, with at least one risk factor including Obesity, Chronic Hypertension, Gestational hypertension, Pre-eclampsia, Eclampsia, Anemia, Use of Oxytocin augmentation >4hrs, Multiparity (Parity >4), Multiple pregnancy, Abnormally implanted placenta, Placenta previa, Abruption, Uterine Leiomyomas, Polyhydramnios, Fetal macrosomia, Previous LSCS, History of postpartum hemorrhage in previous pregnancy, Chorioamnionitis and Cholestasis of pregnancy 
 
ExclusionCriteria 
Details  Patients with Impaired colour vision, Known cardiovascular, renal or liver disorders, Current or past history of DVT, Anticoagulant therapy, Coagulation defects, HELLP syndrome and Sensitivity to Tranexamic acid. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in estimated blood loss in cesarean sections by formula using difference between pre and post op hematocrit and estimated blood volume.

Difference in pre and post op hemoglobin 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Need for blood and blood product transfusion intra-op or post-operatively

Need for additional uterotonics/surgical procedure during cesarean section

Need for additional Tranexamic acid to control bleeding

Maternal and fetal complications related to Tranexamic acid 
1 year 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   05/03/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is being conducted to assess the role of prophylactic Tranexamic acid in reducing blood loss in elective and emergency cesarean sections in women at high risk for postpartum hemorrhage. Hemorrhage is a leading cause of maternal morbidly and mortality. Tranexamic acid is an anti-fibrinolytic agent that helps to reduce bleeding. It is safe in pregnancy (FDA category B). Several studies have been conducted regarding the use of Tranexamic acid to prevent postpartum hemorrhage in cesarean sections with conclusive results showing statistically significant decrease in the blood loss and incidence of post partum hemorrhage. However very little research has been done to study the effectiveness among women with high risk pregnancies. This study aims to bridge that gap. 
 
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