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CTRI Number  CTRI/2021/01/030570 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Open label, analytical study 
Study Design  Other 
Public Title of Study   Clotting ability of blood analysed by thromboelastography in healthy pregnant women undergoing Caesarean or vaginal delivery  
Scientific Title of Study   A comparative study of thromboelastographic parameters in healthy pregnant women undergoing Caesarean or vaginal delivery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sylvia Lhingnunmawi  
Designation  PG student 
Affiliation  Department of Anaesthesiology Lady Hardinge Medical College 
Address  271 A-1 Ground Floor Hauz Rani

Central
DELHI
110017
India 
Phone  09873816858  
Fax    
Email  sylvia27jan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor & Head  
Affiliation  Department of Anaesthesiology Lady Hardinge Medical College 
Address  Department Of Anaesthesiology Lady Hardnge Medical College And Associated Hospitals Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9810570515  
Fax    
Email  maitreepandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor & Head  
Affiliation  Department of Anaesthesiology Lady Hardinge Medical College 
Address  Department Of Anaesthesiology Lady Hardnge Medical College And Associated Hospitals Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9810570515  
Fax    
Email  maitreepandey@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Lady Hardinge Medical College New Delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College  
Address  Shaheed Bhagat Singh Marg New Delhi  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sylvia Lhingnunmawi   Lady Hardinge Medical College and Associated Hospitals  Department of Anaesthesia
Central
DELHI 
9873816858

sylvia27jan@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Healthy pregnant women >18 years posted for Caesarean delivery under spinal anaesthesia or vaginal delivery 
 
ExclusionCriteria 
Details  1)Patients undergoing assisted vaginal delivery (use of forceps and vacuum)
2)Patients receiving preoperative unfractionated heparin, oral anticoagulants or magnesium sulphate
3)Patients with a history of deep vein thrombosis or more than two abortions
4)Patients with history of smoking
5)Patients with hereditary thrombophilia, anti-phospholipid syndrome
6)Patients with sepsis
7)Patients with platelet count < 1 lakh/ mm3 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of healthy pregnant women having deranged thromboelastographic parameters 24
hours after Caesarean delivery and those after vaginal delivery 
Predelivery, 24 hours after delivery and day of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1)Thromboelastographic parameters (Mean ± SD) pre-delivery, 24 hours post-delivery and on the day of discharge in healthy pregnant women after Caesarean or vaginal delivery.
2)Correlation between platelet count, PT, INR, aPTT with MA, R and CI and D-dimer and BT with R, CI and TPI pre-delivery and 24 hr post-delivery in healthy pregnant women undergoing Caesarean delivery and vaginal delivery. 
Pre-delivery,24 hours post-delivery and on the day of discharge 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   25/01/2021 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The physiological changes in pregnancy result in a hypercoagulable state. The concentration of most coagulation factors increases, while factor XI and factor XIII decreases leading to activation of the clotting system. During the first 3 to 5 days postpartum, changes in various procoagulant factors may account for greater incidence of thrombotic complications during the puerperium. 

It has been reported that the risk of thrombosis after vaginal delivery was 1 per 1000 while this risk reaches 3 per 1000 after Caesarean section. The mortality associated with venous thromboembolism after Caesarean section is increased 10-fold compared with women who undergo vaginal delivery.

The conventional blood coagulation tests (prothrombin time, activated partial thromboplastin time, international normalised ratio, platelet count, bleeding time) do not provide a complete picture of hemostasis due to their inability to assess some coagulation factors (such as Factor 13), platelet function and the activity of the fibrinolytic system.

On the other hand, thromboelastography (TEG) is a single test that quantitatively measures the ability of whole blood to form a clot and has become a reliable point-of-care assay for detecting various coagulopathies. In this regard, the advantage of thromboelastography over conventional coagulation parameters include real time assessment to know whether the patient is hypocoagulable, hypercoagulable or fibrinolytic. The aim of the present is to evaluate the role of TEG, in identifying haemostatic alterations in healthy pregnant women undergoing Caesarean delivery and vaginal delivery.

 
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