| CTRI Number |
CTRI/2024/07/069840 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of coagulation profile in severe pre eclampsia and eclampsia patients |
|
Scientific Title of Study
|
An observational study of coagulation profile in severe pre-ecampsia and eclampsia patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Spurthi Prabhakar |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru medical college , Belgavi |
| Address |
Obstetrics And Gynecology Department, ,Jawaharlal Nehru medical college , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9440969906 |
| Fax |
|
| Email |
spurthi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Dalal |
| Designation |
Professor , Department of Obstetrics and Gynecology |
| Affiliation |
Jawaharlal Nehru medical college , Belgavi |
| Address |
Department of Obstetrics and Gynecology , Jawaharlal Nehru medical college , BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
9440969906 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Spurthi Prabhakar |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru medical college , Belgavi |
| Address |
Department of Obstetrics and Gynecology ,Jawaharlal Nehru medical college , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9440969906 |
| Fax |
|
| Email |
spurthi98@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS Jawaharlal Nehru Medical College, Belagavi ,
pin code 590001,
Karnataka,
INDIA |
| platelet count , PT,APTT , serum fibrinogen , D-Dimer will be done , reports will be collected from the patient after consent |
|
|
Primary Sponsor
|
| Name |
Spurthi Prabhakar self |
| Address |
Department of Obstetrics and Gynecology , Jawaharlal Nehru medical college ,Belagavi 590010
Karnataka, INDIA |
| Type of Sponsor |
Other [Deemed university] |
|
|
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 SPURTHI PRABHAKAR |
Prabhakar Kore Hospital ,KAHERs Jawaharlal Nehru Medical college, Belagavi |
OBG department ,1st floor ,Jawaharlal Nehru Medical College , KLE University , Belagavi , KARNATAKA- 590001
Belgaum
KARNATAKA |
9440969906
-
spurthi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
hypertensive females |
|
| ExclusionCriteria |
| Details |
pregnant female with known
history of pre hypertensive disorder
on anticoagulant therapy
established DIC
intrauterine fetal demise.
history of bleeding disorder
abruptio placentae |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
platelet count decreases
PT and APTT is prolonged |
The values will be observed in period of gestation between 20 weeks to 40 weeks , in the above gestational period whenever patients arrives with symptoms of severe pre eclampsia and eclampsia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
13/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is being conducted so as to observe the blood parameters like platelet count, PT ,APTT , serum fibrinogen, D-Dimer in severe pre- eclampsia and eclampsia patients . With pthe help of these parameters we will detect thrombocytopenia and coagulation failure early and manage its complications before it worsens. |