| CTRI Number |
CTRI/2025/12/099772 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study if Oral Tranexamic acid given before birth can reduce blood loss during vaginal delivery in high risk women |
|
Scientific Title of Study
|
Prophylactic Oral Tranexamic acid to reduce blood loss during vaginal delivery in high risk women |
| 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 Soraanganbee Okram |
| Designation |
Primary DNB Resident |
| Affiliation |
Dr. Baba Saheb Ambedkar Hospital, Rohini, Delhi |
| Address |
Residential Complex, Dr. Baba Saheb Ambedkar Hospital, Sector 6 Rohini, Delhi
Sector 6, Rohini, Delhi
North West
DELHI
110085
India |
| Phone |
9818236317 |
| Fax |
|
| Email |
soraanganbee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Khatri |
| Designation |
MD (OBG), SENIOR SPECIALIST AND ASSOCIATE PROFESSOR |
| Affiliation |
DR. BABA SAHEB AMBEDKAR HOSPITAL, ROHINI |
| Address |
Department of obstetrics and gynaecology,first floor,DR. BABA SAHEB AMBEDKAR HOSPITAL, ROHINI, DELHI
North West
DELHI
110085
India |
| Phone |
8130940185 |
| Fax |
|
| Email |
heeragyanee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SONAL PRASAD |
| Designation |
MS(OBG), ASSISTANT PROFESSOR |
| Affiliation |
DR. BABA SAHEB AMBEDKAR HOSPITAL, SECTOR 6, ROHINI, DELHI |
| Address |
Department of obstetrics and gynaecology, first floor,DR. BABA SAHEB AMBEDKAR HOSPITAL, SECTOR 6. ROHINI, DELHI
North West
DELHI
110085
India |
| Phone |
9650549739 |
| Fax |
|
| Email |
sonal.pras@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SECTOR 6 ROHINI, DELHI, India-110085 |
|
|
Primary Sponsor
|
| Name |
DR SORAANGANBEE OKRAM |
| Address |
DR. BABA SAHEB AMBEDKAR HOSPITAL, SECTOR 6, ROHINI, DELHI, India-110085 |
| Type of Sponsor |
Other [SELF] |
|
|
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 SORAANGANBEE OKRAM |
LABOR ROOM, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
DR. BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SECTOR 6 ROHINI, DELHI
North West
DELHI |
9818236317
soraanganbee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, GOVT. OF NCT OF DELHI, SECTOR 6, ROHINI, DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
randomised controlled trial |
The eligible women will be allocated to one of the 2 study groups: Group A (N=200) will receive oral tranexamic acid 1 gm at the end of first stage of labor along with AMTSL and Group B (N= 200) will receive AMTSL without oral TXA. AMTSL includes administration of Injection oxytocin 10 units IM(preferred) within one minute of birth of baby for prophylaxis of PPH. Objectives are to study the efficacy of prophylactic oral tranexamic acid as an adjunct to Active Management of Third Stage of Labor in reducing blood loss at the time of placental separation and immediate postpartum period in high risk vaginal deliveries, to determine the incidence of PPH in 2 groups (with and without oral tranexamic acid) and to study side effects of oral tranexamic acid in the medication group. Dose-1gram, frequency -single dose to be given at the end of first stage of labor,route of administration-oral, total duration of intervention - 24hours |
| Comparator Agent |
RANDOMISED CONTROLLED TRIAL |
The eligible women will be allocated to one of the 2 study groups: Group A (N=200) will receive oral tranexamic acid 1 gm at the end of first stage of labor along with AMTSL and Group B (N= 200) will receive AMTSL without oral TXA. AMTSL includes administration of Injection oxytocin 10 units IM(preferred) within one minute of birth of baby for prophylaxis of PPH. Objectives are to study the efficacy of prophylactic oral tranexamic acid as an adjunct to Active Management of Third Stage of Labor in reducing blood loss at the time of placental separation and immediate postpartum period in high risk vaginal deliveries, to determine the incidence of PPH in 2 groups (with and without oral tranexamic acid) and to study side effects of oral tranexamic acid in the medication group.Dose- 1 gm, frequency - single dose at the end of first stage of labor, route- oral, duration of intervention - 24hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
MODERATE AND SEVERE ANAEMIA
GRAND MULTIPARA
PROLONGED LABOR
MULTIPLE PREGNANCY
MACROSOMIA
POLYHYDRAMNIOS
PIH
APH
ABRUPTION
UTERINE PATHOLOGY LIKE FIBROID
THROMBOCYTOPENIA
PPROM
CHORIOAMNIONITIS
Patient for TOLAC
|
|
| ExclusionCriteria |
| Details |
Known allergy to Tranexamic acid
Patient on LMWH or antiplatelet agent
Medical past history of thromboembolism, autoimmune disease,sickle cell anaemia,bleeding disorders, renal disease,liver disease, known cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the efficacy of prophylactic oral Tranexamic acid as an adjunct to AMTSL in reducingblood loss at the time of placental separation and immediate post partum period upto 2 hours in high risk vaginal deliveries.
2. To determine the incidence of PPH in 2 groups (with and without oral Tranexamic acid). |
2 hours post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To study side effects of oral Tranexamic acid in the medication group. |
2 hours post delivery |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 4 |
|
Date of First Enrollment (India)
|
26/12/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
WHO trial has shown that IV tranexamic acid is effective in management of PPF but at lower level health facilities or home deliveries, parenteral administration is not practicable. In such situation, oral tranexamic acid if found to be effective in reducing blood loss after delivery, can be used by the concerned health care providers/ low resources set up areas. As high risk parturients for obstetrical haemorrhage may be the one that would benefit the most from prophylactic tranexamic acid. |