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CTRI Number  CTRI/2021/06/034324 [Registered on: 21/06/2021] Trial Registered Prospectively
Last Modified On: 20/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Detecting bleeding problems in patients who develop very high BP during Pregnancy  
Scientific Title of Study   Role of Thromboelastography parameters in Hypertensive Disorders of Pregnancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparajita Sinha 
Designation  Junior Resident 
Affiliation  KMC Manipal  
Address  Room 310, NIH block A. Madhav Nagar Manipal 576104
Madhav Nagar. Manipal
Udupi
KARNATAKA
576104
India 
Phone  9304167791  
Fax    
Email  aparajita1594@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna Amin 
Designation  Associate Professor  
Affiliation  KMC Manipal  
Address  Dept of OBG, Kasturba Hospital, Manipal 576104
Madhav Nagar. Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  9880916061  
Fax    
Email  drsapnagoni@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aparajita Sinha 
Designation  Junior Resident 
Affiliation  KMC Manipal  
Address  Room 310, NIH block A. Madhav Nagar Manipal 576104
Madhav Nagar. Manipal
Udupi
KARNATAKA
576104
India 
Phone  9304167791  
Fax    
Email  aparajita1594@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hsopital  
 
Primary Sponsor  
Name  KMC Manipal  
Address  Kasturba medical College, Madhav Nagar, Manipal Karnataka 576104 
Type of Sponsor  Private 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 Aparajita Sinha  Kasturba Hospital   Department of OBG, Woman and Child Block, Kasturba Hospital, Madhav Nagar Manipal 576104
Udupi
KARNATAKA 
9304167791

aparajita1594@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KMC Manipal  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  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  For Cases - Singleton pregnancy with Severe Pre-eclampsia requiring immediate intervention
Controls - Singleton pregnancy with Pre-eclampsia that can undergo expectant
management 
 
ExclusionCriteria 
Details  For Cases - Pre-eclampsia patients that can undergo expectant management, Multiple gestation, Any other causes of bleeding in pregnancy
For Controls - Multiple gestation, Any other causes of bleeding in pregnancy, Patients with severe pre eclampsia and eclampsia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of type of coagulopathy based on scores of R value, K value, ‘a’ angle, MA, CI, Ly30
• R value - Represents period of time of latency from start of test to initial fibrin formation
• K time - Represents time taken to achieve a certain level of clot strength - equates to amplitude 20 mm
• Alpha Angle Measures the rapidity of fibrin build-up and cross-linking (clot strengthening)
• MA - represents the ultimate strength of the fibrin clot
 
4 months  
 
Secondary Outcome  
Outcome  TimePoints 
Providing Blood component as per result of TEG
Further management as per protocol of hospital in high dependency unit. 
Outcome assessed every 8 weeks 
 
Target Sample Size   Total Sample Size="181"
Sample Size from India="181" 
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)   25/06/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
One of the complications occuring during pregnancy is Hypertensive disorders that can range from only high BP recording to multiple organ involvement including liver injury and bleeding disorder. Thromboelastography is a Test that examines type of bleeding disorder  that the pregnant mother has been affected with. Routine Hemostatic tests i.e PT APTT INR Platelets have been routinely used to detect coagulopathy associated with Hypertensive disorders of pregnancy which are individualised tests for the 3 different stages of hemostasis. However, Thromboelastography is a single test that can detect abnormalities of any stage of hemostasis. The benefits would be less time as it takes only one hour which would cut short the time taken to decide further management, it is one test in place of multiple tests and that the IHBT would also provide suggestions regarding the Blood type required to correct the particular type of Coagulopathy . Therefore more objective Test for assessing coagulopathy associated with Hypertensive disorders of pregnancy, result in better decision making in plan of action regarding the condition. Hence it would be beneficial if this is found to be useful it can be incorporated as a single test as a routine method for evaluation.
 
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