| CTRI Number |
CTRI/2024/09/074219 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Research focussed on developing a risk prediction models for pre-eclampsia to enhance early identification in pregnancies, particularly tailored for Indian population. |
|
Scientific Title of Study
|
Validation of performance of multiparametric risk prediction models for preeclampsia in
early pregnancy and determination of the best fit model for Indian Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
7th Floor Room No 711, MCH Block, AIIMS,
New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
7th Floor Room No 711, MCH Block, AIIMS,
New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
7th Floor Room No 711, MCH Block, AIIMS,
New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. All India Institute of Medical Sciences, New Delhi, Ansari Nagar, 110029
2. Translational Health Science and Technology Institute(THSTI), NCR Biotech Science Cluster, 3rd Milestone , Faridabad- Gurugram Expressway |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
1. All India Institute of Medical Sciences, New Delhi, Ansari Nagar, 110029
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr K Aparna Sharma |
All India Institute of Medical Sciences |
Department of Obstetrics and Gynaecology, Room No. 711, Mother and child block, AIIMS New Delhi, Ansari Nagar, 110029
South
DELHI |
9711824415
kaparnasharma@gmail.com |
| Dr Nitya Wadhwa |
Translational Health Science and Technology Institute |
NCR Biotech Science Cluster, 3rd Milestone , Faridabad- Gurugram Expressway
Faridabad
HARYANA |
9811142248
nitya.wadhwa@thsti.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
| THSTI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O14||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 |
More than 14 weeks of pregnancy
Willing to be a part of the study |
|
| ExclusionCriteria |
| Details |
1. women not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-eclampsia |
At 20 weeks or more period of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the performance of maternal history-based prediction models (in the Indian population
2) To calibrate the risk prediction model for selecting the high-risk group that could benefit from the prophylactic use of aspirin in the Indian population for singleton pregnancies |
During and end of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="1139"
Sample Size from India="1139"
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)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2024 |
| 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 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 occurs in 2–8%
of pregnancies worldwide and is the second leading cause of direct maternal and
fetal deaths. In India, the reported incidence of eclampsia varies from
0.17 to 3.7% and maternal mortality of eclamptic women varies from 2.2% to 23%. The
early detection of the risk of this complication may allow for the improvement
of the maternal and fetal outcome by increasing patient surveillance or by
initiating a therapeutic intervention. The current prediction model used
across the globe, especially in the UK, is a multiparametric test involving
biophysical and biomarkers to predict the occurrence of preeclampsia. There
is a concern that the implementation of the screening protocols may require
local modification and the estimate of performance from the literature may not
be applicable to all populations. Thus, it is important to evaluate the
performance of various multiparametric tests for screening of preeclampsia in
the Indian population and validate the same. |