| CTRI Number |
CTRI/2025/03/082530 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study how the severity of preeclampsia in pregnant females is associated with changes in blood parameters and biochemical parameters |
|
Scientific Title of Study
|
A study on association of hematological and biochemical indices with disease severity in preeclampsia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Katiyar |
| Designation |
Junior resident |
| Affiliation |
GSVM medical College |
| Address |
Department of physiology
GSVM medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7651877989 |
| Fax |
|
| Email |
prinkskat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dolly Rastogi |
| Designation |
Head of department |
| Affiliation |
Gsvm medical College |
| Address |
Physiology department
Gsvm medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8400331162 |
| Fax |
|
| Email |
drdollyrastogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dolly Rastogi |
| Designation |
Head of department |
| Affiliation |
Gsvm medical College |
| Address |
Physiology department
Gsvm medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8400331162 |
| Fax |
|
| Email |
drdollyrastogi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Priyanka Katiyar (self) Upper India Sugar exchange maternity Hospital, Kanpur, India,208002 |
| Dr Priyanka Katiyar (self)GSVM MEDICAL COLLEGE , Kanpur,India, 208002 |
|
|
Primary Sponsor
|
| Name |
Priyanka Katiyar |
| Address |
Physiology department
Gsvm medical College
Kanpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Katiyar |
GSVM MEDICAL COLLEGE |
Room no.6, Physiology department
Kanpur Nagar
UTTAR PRADESH |
7651877989
prinkskat@gmail.com |
| Priyanka Katiyar |
Upper India Sugar exchange maternity Hospital , LLR |
Opd no.6
Labour room 1,
Ward 4,
Obstetrics and Gynaecology department
Kanpur Nagar
UTTAR PRADESH |
7651877989
prinkskat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy with diagnosed preeclampsia |
|
| ExclusionCriteria |
| Details |
Women with multiple gestation
Women with diabetes mellitus
Women with chronic hypertension
Women with pre-existing renal disease, cardiovascular disease, liver disease, dyslipidemia,any thyroid disease
Women with active labour, PROM, polyhydramnios, severe anemia, IUD
Women with infectious diseases diagnosed during pregnancy
Women having chronic inflammatory disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| It might be possible to predict the severity of preeclampsia by platelet indices, liver function test, renal function test and thyroid stimulating hormone. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preeclampsia whether severe or non severe might lead to preterm delivery & risk of preeclampsia in subsequent pregnancies |
1 year |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
24/03/2025 |
| 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 Yet Recruiting |
| 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
|
Preeclampsia is a hypertensive disorder of pregnancy with significant morbidity and mortality. It has been seen that there are changes in blood parameters, liver function and renal function during the course of disease. In this study approach is to identify such changes which might predict severity of disease at proper time so that timely interventions can be taken. |