| CTRI Number |
CTRI/2024/12/078225 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of Blood loss after normal delivery |
|
Scientific Title of Study
|
Assessment of blood loss after vaginal delivery with the use of tranexamic acid in third stage of labour . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVijaylakshmi |
| Designation |
junior resident |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Office of department of obstetrics and gynaecology nehru hospital 3rd floor room no.10 pgimer chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7006293980 |
| Fax |
|
| Email |
vjlakshmideepak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Seema chopra |
| Designation |
Professor obstetrics and gynaecology |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Office of department of obstetrics and gynaecology nehru hospital 3rd floor pgi chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209351 |
| Fax |
|
| Email |
drseemachopra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Vijaylakshmi |
| Designation |
junior resident |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Office of department of obstetrics and gynaecology nehru hospital 3rd floor pgimer chandigarh
OFFICE OF DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7006293980 |
| Fax |
|
| Email |
vjlakshmideepak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru hospital department of obstetrics and gynaecology
PGIMER Chandigarh
160012
India |
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY PGIMER CHANDIGARH 160012
chandigarh |
| 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 vijaylakshmi |
pgimer chandigarh |
Labour room of Department of obstetrics and gynaecology
Chandigarh
CHANDIGARH |
7006293980
vjlakshmideepak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND TRESEARCH, CHANDIGARH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O60-O77||Complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oxytocin |
In 2nd group , placebo ( 10ml NS) will be administered along with oxytocin 10 units in 500ml NS over 4 hours |
| Intervention |
TRANEXAMIC ACID + OXYTOCIN |
TWO GROUPS WILL BE MADE
IN FIRSTGROUP,1 g TRANEXAMIC ACID WILL BE ADMINISTERED INTRAVENOUSLY at a rate of 1ml/ minuteALONG WITH OXYTOCIN 10 units in 500ml NS I/V over 4 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
women in labour
women willing for participation |
|
| ExclusionCriteria |
| Details |
Women not willing for participation.
Period of gestation ≤ 28 weeks
Elective or emergency caesarean sections.
Women with underlying medical disorders such as cardiovascular, hepatic, renal disorder or seizure disorders.
History of allergy to tranexamic acid or excipients.
Patients on anticoagulation.
Patients not in a sound state to give consent. (eclampsia, psychiatric disorders)
h/o thromboembolic event during pregnancy.
coagulation disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of blood loss after normal vaginal delivery in ml . |
Amount of blood loss will be measured till 6 hours after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study haemoglobin differences pre- & post-delivery in two groups.
To study the proportion of women requiring additional uterotonics in two groups.
To study the women requiring blood transfusion in two groups.
To study the women requiring additional surgical interventions in two groups.
|
6 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
FIGO and WHO recommends the use of oxytocin as the first line uterotonic drug for the prevention of PPH. Intravenous oxytocin infusion alone is the recommended uterotonic drug for the treatment of PPH. Tranexamic acid is used in the treatment of PPH if oxytocin and other uterotonics fail to stop bleeding or if it is thought that blood loss may be partly due to trauma. TXA is proven efficient in the treatment of PPH and has an advantage over oxytocin in decreasing blood loss in traumatic PPH as oxytocin can prevent blood loss in atonic PPH only. Also, TXA doesn’t require cold storage, easily available over the counter, doesn’t lead to volume overload in patients with heart disease, anaemia etc. So ,we are thinking to extend the use of TXA as a prophylactic agent for preventing PPH.
Oxytocin is used as a standard drug for preventing PPH. We will add a drug with different mechanism of action, TXA, with oxytocin to see whether the combination is more effective in preventing PPH. If proven more effective, TXA can be compared with oxytocin alone in preventing PPH.
|