| CTRI Number |
CTRI/2024/04/066348 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To give tranexamic acid in reducing postpartum blood loss in vaginal deliveries |
|
Scientific Title of Study
|
Effect of prophylactic tranexamic acid in reducing postpartum blood loss in vaginal deliveries at tertiary care centre; placebo controlled randomized clinical 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 Seema |
| Designation |
junior resident |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Umaid hospital
Obstetrics and Gynecology
Labor room
Jodhpur
RAJASTHAN
342003
India |
| Phone |
09166864816 |
| Fax |
|
| Email |
seemanvi1196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hanslata Gehlot |
| Designation |
Senior professor and unit head |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Umaid hospital
Obstetrics and Gynecology
Labor room
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9079320629 |
| Fax |
|
| Email |
pummyia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema |
| Designation |
junior resident |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Umaid hospital
Obstetrics and Gynecology
Labor room
Jodhpur
RAJASTHAN
342003
India |
| Phone |
09166864816 |
| Fax |
|
| Email |
seemanvi1196@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SN MEDICAL COLLEGE,
Shashtri circle, Jodhpur
342001
Rajasthan
India |
|
|
Primary Sponsor
|
| Name |
DR SN MEDICAL COLLEGE |
| Address |
Shashtri Nagar ,Jodhpur
Pin code-342001
Rajasthan
India |
| Type of Sponsor |
Government medical college |
|
|
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 SEEMA |
Umaid hospital |
Obstetrics and gynecology
labor room
Jodhpur
RAJASTHAN |
09166864816
seemanvi1196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Dr Sampurnanand medical college, jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ALL HEALTHY PREGNANT WOMEN FULFILLING THE INCLUSION CRITERIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Injection normal saline 10 ml slow intravenous infusion over 10 minutes single dose |
| Intervention |
Tranexamic acid |
Injection Tranexamic acid 1 gram
slow direct intravenous infusion
in 10 ml diluent over 10 minutes
single dose |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
prmigravida or secondary gravida
37 to 42 weeks of gestation
admitted in active labour
normotensive
cephalic presentation |
|
| ExclusionCriteria |
| Details |
All other patients not fulfilling the inclusion criteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To quantify the mean 2hour postpartum blood loss |
from delivery to 2 hour postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see if any other intervention needed after delivery & to compare the need of blood transfusion & to see the potential adverse effects of tranexamic acid.
|
from delivery till patient discharged. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2024 |
| 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
|
Intravenous infusion of 1 gm Tranexamic acid in 10 ml diluent over 10 minutes will be given to the patients at the time of delivery. Aim of the study is to minimize the mortality and morbidity due to postpartum blood loss. |