| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
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. |