| 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
|
|
|
Primary Sponsor
|
| Name |
KMC Manipal |
| Address |
Kasturba medical College, Madhav Nagar, Manipal Karnataka 576104 |
| Type of Sponsor |
Private 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 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
|
|
|
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 |
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
|
|
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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. |