| CTRI Number |
CTRI/2019/01/017077 [Registered on: 14/01/2019] Trial Registered Prospectively |
| Last Modified On: |
10/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a drug,injection tranexamic acid in reducing the amount of blood loss after a normal delivery, in comparison with an inactive medicine like normal saline. |
|
Scientific Title of Study
|
INJECTION TRANEXAMIC ACID FOR PREVENTING POSTPARTUM HEMORRHAGE AFTER VAGINAL DELIVERY: ONE YEAR HOSPITAL BASED RANDOMIZED,PLACEBO-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 |
Dr Kshama A Hinchigeri |
| Designation |
Post Graduate student |
| Affiliation |
KLE Universitys J N Medical college ,Belgaum |
| Address |
Post Graduate student
Department of Obstetrics and Gyneacology,
KLE Academy Of Higher Education and Research Institute,
Jawaharlal Nehru Medical College,
Nehru nagar,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9071978689 |
| Fax |
|
| Email |
kshamah92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal P Patil |
| Designation |
Professor and Head |
| Affiliation |
KLE Universitys J N Medical college ,Belgaum |
| Address |
Department of Obstetrics and Gyneacology,
KLE Academy Of Higher Education and Research Institute,
Jawaharlal Nehru Medical College,
Nehru nagar,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal P Patil |
| Designation |
Professor and Head |
| Affiliation |
KLE Universitys J N Medical college ,Belgaum |
| Address |
Department of Obstetrics and Gyneacology,
KLE Academy Of Higher Education and Research Institute,
Jawaharlal Nehru Medical College,
Nehru nagar,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KLE Universitys J N Medical college
KLE University Campus
Nehru Nagar
belgaum
|
|
|
Primary Sponsor
|
| Name |
Dr Kshama A Hinchigeri |
| Address |
Post Graduate student
Department of Obstetrics and Gyneacology,
KLE Academy Of Higher Education and Research Institute,
Jawaharlal Nehru Medical College,
Nehru nagar,
Belagavi |
| 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 Kshama A Hinchigeri |
KLEs Dr Prabhakar Kore Charitable Hospital |
Labour room,
Minus 1 floor,KLEs Dr Prabhakar Kore Charitable Hospital,
Nehru Nagar,
Belagavi-590100
Belgaum
KARNATAKA |
9071978689
kshamah92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
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 |
| Intervention |
Injection tranexamic acid |
Dose is 1 gram.
Frequency is single dose.
Administered by intravenous route.
Total duration of therapy-the drug will be given within 2 minutes from time of delivery of baby and
will be administered as a single dose slowly over a minute. |
| Comparator Agent |
Placebo-Normal saline |
Dose is 10 ml of normal saline.
Frequency is single dose.
Administered by intravenous route.Total duration of therapy - the drug will be given within 2 minutes from time of delivery of baby and will be administered as a single dose slowly over a minute. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Term pregnancy
2)Planned vaginal delivery
3)Singleton pregnancy
|
|
| ExclusionCriteria |
| Details |
1)History of thrombosis
venous-deep vein thrombosis and/or pulmonary embolism
arterial -angina pectoris, myocardial infarction, stroke
2)History of epilepsy or seizure
3)Any known cardiovascular, renal, or liver disorders
4)Autoimmune disease
5)Sickle cell disease
6)Severe hemorrhagic disease
7)Placental Abnormalilty-
8)Placenta previa
9)Invasive placenta (placenta accreta/ increta/
percreta)
10)Abruptio placentae
11)Eclampsia, and HELLP syndrome
12)Intra utero fetal death
13)Administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery
14)Caeserean sections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Amount of blood loss at the end of 30 minutes and at the end of 2 hours .
Mean total blood loss is total blood in the calibrated collector bag at the time of bag removal. |
Blood loss- End of 30 minutes
End of 2 hours
Time of removal of bag |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laboratory parameters
Hemoglobin
Packed Cell Volume(PCV)
The mean change in peripartum hemoglobin and PCV will be calculated
|
Postnatal day 2 |
| Adverse effects of the drug will be noted by monitoring hemodynamic parameters and by follow up visits upto 3 months in the post natal period. |
Hemodynamic parameters
15 minutes
30 minutes
45 minutes
1 hour
2 hour
follow up for major adverse effects till 3 months post delivery |
Patients will be followed up until the day of discharge to know incidence of
Postpartum blood transfusion
Arterial embolization
Emergency hysterectomy
|
Date of discharge |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2019 |
| 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
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an interventional , randomized, placebo controlled trial to asses the effect of injection tranexamic acid in preventing postpartum hemorrhage after a vaginal delivery, conducted at a tertiary care centre. This study will enroll term pregnant women who are planned for vaginal delivery .Women who have even one of the exclusion criteria will not be enrolled into this study..Randomization will be done by computer based randomisation. Soon after the delivery of the baby, injection tranexamic acid or placebo which is normal saline will be given by intravenous route. The primary outcome will be assessed by the amount of blood loss in the calibrated collector bag which will be placed under the waist of the woman soon after delivery of baby. The secondary outcome will be assessed by the mean change in hemoglobin and packed cell volume.Adverse effects of the drug which include immediate and long term adverse effects will also be studied. |