| CTRI Number |
CTRI/2025/05/087831 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Third trimester Risk Assessment for Preeclampsia using sFLT-1 Lateral-flow assay (LFA) biomarker test |
|
Scientific Title of Study
|
Third trimester Risk Assessment for Preeclampsia using sFLT-1 Lateral-flow assay (LFA) biomarker test: A prospective observational study |
| 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 Manisha Kumar |
| Designation |
Director Professor, Department of gynaecology and obstetrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of gynaecology and obstetrics,Old Building, Gate Number 1,
Lady Hardinge Medical College,
, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi
Central
DELHI
110001
India |
| Phone |
9818014887 |
| Fax |
|
| Email |
manishaonly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Kumar |
| Designation |
Director Professor, Department of gynaecology and obstetrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of gynaecology and obstetrics,Old Building, Gate Number 1,
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi
Central
DELHI
110001
India |
| Phone |
9818014887 |
| Fax |
|
| Email |
manishaonly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Kumar |
| Designation |
Director Professor, Department of gynaecology and obstetrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of gynaecology and obstetrics,Old Building, Gate Number 1,
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi
Central
DELHI
110001
India |
| Phone |
9818014887 |
| Fax |
|
| Email |
manishaonly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cedars Sinai Medical Center, Cedars-Sinai, 8700 Beverly Blvd, AHSP-A8110A, Los Angeles, California, 90048 |
|
|
Primary Sponsor
|
| Name |
Cedars Sinai Medical Center |
| Address |
Cedars Sinai Medical Center,
Cedars-Sinai, 8700 Beverly Blvd,
AHSP-A8110A, Los Angeles, California, 90048.
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Malawi
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Kumar |
Lady Hardinge Medical College |
Department of gynaecology and obstetrics, Maternity Ward 1,Old Building,
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
9818014887
manishaonly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lady Hardinge Medical College & Associated Hospitals |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Current singleton pregnancy
2. Gestational age 23 0/7 to 37 0/7 weeks that is confirmed by ultrasound estimation.
3. Women presenting with clinical suspicion of PE (new onset high blood pressure or worsening of chronic hypertension, edema or excess weight gain, proteinuria, headache, abdominal pain, visual symptoms) |
|
| ExclusionCriteria |
| Details |
1. Multiple pregnancy
2. Patient is enrolled in another clinical trial
3. Patients receiving intravenous heparin |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The performance of Gravidas LFA test (Sensitivity, Specificity, PPV and NPV) in predicting severe PE in the suspected preeclampsia population.
2. The performance (Sensitivity, Specificity, PPV and NPV) of sFLT-1 and PlGF ratio in predicting severe PE in the suspected preeclampsia population.
|
The collected blood samples will be assessed using the diagnostic tool every 3rd month. And will be cross verified with the adverse maternal & fetal outcome data collected after delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The performance of Gravidas LFA test (Sensitivity, Specificity, PPV & NPV) in
predicting severe PE in the suspected preeclampsia population
2. The performance (Sensitivity, Specificity, PPV & NPV) of Sflt-1/ PlGF ratio in
predicting severe PE in the suspected preeclampsia population
|
The collected blood samples will be assessed using the diagnostic tool every 3rd month. And will be cross verified with the adverse maternal & fetal outcome data collected after delivery. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="500"
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)
|
30/06/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective observational study evaluates the effectiveness of the Gravidas LFA test, a point-of-care diagnostic tool, in predicting severe preeclampsia (sPE) and adverse maternal/perinatal outcomes within two weeks in high-risk pregnant women. The Gravidas LFA, which estimates sFLT-1 levels, is compared to standard clinical indicators and the Roche Elecsys platform’s sFLT-1/PlGF ratio test. Objectives
-
Assess Gravidas LFA’s performance (sensitivity, specificity, PPV, NPV) in predicting sPE.
-
Compare Gravidas LFA’s predictive value with that of the sFLT-1/PlGF ratio from standard testing.
Clinical Relevance
Current clinical signs (e.g., blood pressure, proteinuria, edema, etc) poorly predict sPE. While sFLT-1/PlGF testing is FDA-approved, it’s not feasible in low-resource settings. Gravidas LFA offers a fast, low-cost, and effective alternative, potentially improving early detection and intervention in underserved areas. Study Design & Methodology
The trial involves 500 third-trimester women with suspected PE. Blood samples will be tested using both Gravidas LFA test and standard Roche Elecsys platforms. Participants will be followed through delivery to document outcomes.
Impact
Wider implementation of Gravidas LFA may enhance patient care, reduce healthcare burden, and save maternal & fetal lives in low/middle-income countries. |