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
|
|
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
|
|
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. |