| CTRI Number |
CTRI/2024/05/067790 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness and safety of using intravenous injection tranexamic acid before vaginal/caesarean delivery in order to avoid excessive blood loss after delivery. |
|
Scientific Title of Study
|
Efficacy and safety of IV Tranexamic acid in the prevention of postpartum haemorrhage:A Randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aradhya Garg |
| Designation |
Junior Resident Second Year |
| Affiliation |
King George Medical University,Lucknow,Uttar Pradesh |
| Address |
Department of obstetrics and gynaecology,queen mary’s hospital,King George’s Medical University,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9557407915 |
| Fax |
|
| Email |
aradhyag567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Mehrotra |
| Designation |
Proffesor |
| Affiliation |
King George Medical University,Lucknow,Uttar Pradesh |
| Address |
Department of obstetrics and gynaecology,queen mary’s hospital,King George’s Medical University,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9918924300 |
| Fax |
|
| Email |
mehrotra.seema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aradhya Garg |
| Designation |
Junior Resident Second Year |
| Affiliation |
King George Medical University,Lucknow,Uttar Pradesh |
| Address |
Department of obstetrics and gynaecology,queen mary’s hospital,King George’s Medical University,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9557407915 |
| Fax |
|
| Email |
aradhyag567@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George’s Medical university , Lucknow,UP, India, Pincode-226003 |
|
|
Primary Sponsor
|
| Name |
Aradhya Garg |
| Address |
Department of obstetrics and gynaecology,queen mary’s hospital ,King George’s medical university ,Chowk, Lucknow , Pincode-226003 |
| 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 |
| DrAradhya Garg |
Labour room ,room number 1 ,department of obstetrics and gynaecology,queen mary’s hospital,kgmu |
Queen mary’s hospital,department of obstetrics and gynaecologyKGMU
Lucknow
UTTAR PRADESH |
9557407915
aradhyag567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,King George Medical University, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not recieving prophylactic tranexamic acid I.V and managing PPH by standard protocol. |
Women undergoing vaginal delivery –
Women will receive IV 10 ml saline slowly during 30-60 sec during crowning of the fetal head .After vaginal delivery active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Women undergoing caesarean section-
In caesarean births, the IV 10 ml i. V saline slowly during 30-60 sec will be given prior to skin incision, immediately after draping
This will be followed by active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Delivered women will be followed for any amount of blood loss .The amount of blood loss after vaginal delivery will be estimated using Caliberated drapes placed under the buttocks after delivery and using pictorial charts .
During LSCS blood loss will be estimated using Gravimetrical estimation method assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted or provider estimated blood loss by the surgical team whichever is feasible.
Those women who will develop atonic PPH ( defined as blood loss 500 ml after vaginal delivery or 1000 ml after LSCS or any blood loss sufficient to compromise haemodynamic stability within 24 h of birth will be managed as per protocol.
Pulse and BP will be recorded at intervals of 15 minutes.
The uterine tone and amount of bleeding will be assessed and need for further uterotonics will be determined. |
| Intervention |
Receiving IV Tranexamic acid (1 gm ) |
Women undergoing vaginal delivery –
Women will receive IV(route) tranexamic acid (frequency-only once) slowly during 30-60 sec during crowning of the fetal head .After vaginal delivery active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Women undergoing caesarean section-
In caesarean births, the IV tranexamic acid slowly during 30-60 sec will be given prior to skin incision, immediately after draping
This will be followed by active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Delivered women will be followed for any amount of blood loss .The amount of blood loss after vaginal delivery will be estimated using Caliberated drapes placed under the buttocks after delivery and using pictorial charts .
During LSCS blood loss will be estimated using Gravimetrical estimation method assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted or provider estimated blood loss by the surgical team whichever is feasible.
Those women who will develop atonic PPH ( defined as blood loss 500 ml after vaginal delivery or 1000 ml after LSCS or any blood loss sufficient to compromise haemodynamic stability within 24 h of birth will be managed as per protocol.
Pulse and BP will be recorded at intervals of 15 minutes.
The uterine tone and amount of bleeding will be assessed and need for further uterotonics will be determined.
As per duration of intervention hemoglobin will be measured after 48hrs of delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.All women undergoing vaginal delivery/LSCS at QMH,KGMU.
2.Patient who have given written informed consent will be taken
|
|
| ExclusionCriteria |
| Details |
1.Patient not giving written informed consent
2.Antenatal diagnosis of placenta accreta spectrum (PAS),
3.Genital tract trauma
4.Known background of thrombophilia or coagulopathy
5.Women with renal, cardiac or liver disease.
6.Known hypersensitivity with tranexamic acid.
7.Women with increased risk of arterial or venous thrombosis
8.Women with epilepsy or seizures
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Calculated EBL(cEBL)-Estimated blood vol×(predelivery or preop haematocrit− Post delivery or postop haematocrit)/predelivery or preop haematocrit. Estimated blood vol in ml -bodyweight in kg×85. For participants who received transfusion before postnatal blood sample taken,the corrected postop hb will be post-transfusion hb 48 hrs postop− (1 × unit of RBC transfused), and postop haematocrit as post-transfusion haematocrit 48 hrs postop − (3 × units of RBC transfused).
|
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Need for additional medical interventions (additional uterotonics, additional TXA
2.Need for additional surgical & mechanical interventions for haemostasis
3.Need of blood and blood products
4.Difference between hemoglobin before and after 24 hours of delivery.
5.Adverse events like nausea, vomiting, photopsia (sensation of seeing lights, sparks, or flashes of color) or thromboembolic event
|
Immediate post partum till next 48 hours |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="6"
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
|
All women undergoing vaginal delivery/LSCS admitted in Dept of Obstetrics and Gynaecology,KGMU fulfilling the inclusion criteria will be enrolled after written informed consent. Information on age, education, parity, occupation, income and obstetric history will be obtained from the woman using a questionnaire. Using a computer generated randomisation sequence, eligible pregnant women in the study will be randomly divided into two equal groups of 240 (240 in each group) Participants haemoglobin & haematocrit levels will determined within the week before delivery Group 1- Receiving IV Tranexamic acid (1 gm ) Group 2- Control group ( Not receiving IV tranexamic acid ) Women undergoing vaginal delivery – Women will receive IV tranexamic acid slowly during 30-60 sec during crowning of the fetal head .After vaginal delivery active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction. Women undergoing caesarean section- In caesarean births, the IV tranexamic acid slowly during 30-60 sec will be given prior to skin incision, immediately after draping This will be followed by active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction. Delivered women will be followed for any amount of blood loss .The amount of blood loss after vaginal delivery will be estimated using Caliberated drapes placed under the buttocks after delivery and using pictorial charts . During LSCS blood loss will be estimated using Gravimetrical estimation method assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted or provider estimated blood loss by the surgical team whichever is feasible. Those women who will develop atonic PPH ( defined as blood loss >500 ml after vaginal delivery or >1000 ml after LSCS or any blood loss sufficient to compromise haemodynamic stability within 24 h of birth will be managed as per protocol. Pulse and BP will be recorded at intervals of 15 minutes. The uterine tone and amount of bleeding will be assessed and need for further uterotonics will be determined. Need for blood or other blood products transfusion. Participants haemoglobin & haematocrit levels will be repeated around 24 hours post-delivery. The total amount of blood loss will then be objectively calculated using blood volume and haematocrit of the woman using the formula |