| CTRI Number |
CTRI/2021/02/030965 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of clotting of blood using thromboelastography in pregnant patients with pre-eclampsia |
|
Scientific Title of Study
|
A study of thromboelastographic parameters in patients with pre-eclampsia undergoing caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niharika Rani |
| Designation |
Post graduate student in anaesthesiology |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of Anaesthesiology,Lady Hardinge Medical college,connaught place
Shaheed bhagat singh marg,new delhi
New Delhi
DELHI
110001
India |
| Phone |
9570880299 |
| Fax |
|
| Email |
niharikarathore2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maitree Pandey |
| Designation |
Director Professor and Head |
| Affiliation |
LHMC |
| Address |
Department of Anaesthesiology,Lady Hardinge Medical college,connaught place
Shaheed bhagat singh marg,new delhi
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
maitreepandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maitree Pandey |
| Designation |
Director Professor and Head |
| Affiliation |
LHMC |
| Address |
Department of Anaesthesiology,Lady Hardinge Medical college,connaught place
Shaheed bhagat singh marg,new delhi
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
maitreepandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady hardinge medical college |
|
|
Primary Sponsor
|
| Name |
Lady hardinge medical college |
| Address |
Shaheed bhagat singh marg,new delhi |
| 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 |
| Niharika Rani |
Lady Hardinge Medical college |
Main Operation theatre and Obstetric ward
Central
DELHI |
9570880299
niharikarathore2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O14||Pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Age >18 years.
Third trimester(≥32 weeks of gestation) patients with diagnosed pre-eclampsia undergoing Caesarean delivery. |
|
| ExclusionCriteria |
| Details |
Patients prescribed preoperative unfractionated heparin,oral anticoagulants or receiving magnesium therapy.
Patients with a history of deep vein thrombosis,more than two abortions and smoking.
Patients with hereditary thrombophilia or Anti phospholipid antibody syndrome (APLA).
Patients with sepsis.
Patients with major blood loss during surgery or requiring postoperative ventilation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of pre-eclamptic patients with deranged thromboelastographic parameters 24 hours post operatively. |
pre delivery,24 hour and 5th day post caesarean delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Thromboelastographic parameters (Mean ± SD) preoperatively, 24 hours and 5th day postoperatively in patients with pre-eclampsia after Caesarean delivery.
Correlation between coagulation parameters (platelet count, PT, INR, aPTT) with Maximum amplitude, Reaction time, Thrombogenic Potential Index and Coagulation Index; and D-dimer and bleeding time with Reaction time, Thrombogenic Potential Index and Coagulation Index preoperatively and 24 hours postoperatively. |
pre delivery,24 hour and 5th day post caesarean delivery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2021 |
| 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="5"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published in a scientific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre-eclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation accompanied by new-onset proteinuria and other signs or symptoms of pre-eclampsia in the absence of proteinuria.Pre-eclampsia complicates 3.8% of pregnancies in India and represents a significant cause of maternal and perinatal morbidity and mortality. Women with pre-eclampsia are at a greater risk of cerebrovascular and cardiovascular events, organ failure and disseminated intravascular coagulation. Foetus of these mothers are at greater risk of fetal growth retardation, prematurity and intrauterine death. The aetiology of pre-eclampsia remains unclear. Currently, generally accepted theories assume that abnormal placental implantation in the early stage of pregnancy causes systemic vascular endothelial cell disorder and dysfunction and may lead to the development of hypertension, proteinuria, blood hypercoagulability, and other clinical manifestations. These changes start reverting with the delivery of the baby. However, most of the thromboembolic complications occur postdelivery. Therefore, it is important to recognise women at risk for these fatal complications.
Thromboelastography (TEG) has become a reliable point-of-care assay for detecting various coagulopathies. The advantages of thromboelastography over traditional coagulation parameters include provision of reliable evidence to diagnose disease related to coagulation defects, as well as real-time assessment to know whether the patient is hypocoagulable, hypercoagulable or fibrinolytic. Limited information exists regarding thromboelastography parameters throughout pregnancy among patients with pre-eclampsia. Since patients with pre-eclampsia are at risk of thromboembolic complications moreso after Caesarean delivery, it is important to recognise the women at risk and to know whether this hypercoagulable state persists through the entire puerperium. After extensive search of literature, till date there are few studies comparing TEG parameters in patients with pre-eclampsia preoperatively, 24 hours and 5th day postoperatively after Caesarean delivery. Therefore, the present study has been planned to compare TEG parameters in the postpartum period as compared to their pre-operative status in patients with pre-eclampsia. |