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Third trimester Risk Assessment for Preeclampsia using sFLT-1 Lateral-flow assay (LFA) biomarker test

Third trimester Risk Assessment for Preeclampsia using sFLT-1 Lateral-flow assay (LFA) biomarker test: A prospective observational study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/087831
Enrollment
1000
Registered
2025-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O14- Pre-eclampsia

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Cedars Sinai Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Patient is enrolled in another clinical trial 3. Patients receiving intravenous heparin

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 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

MeasureTime frame
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 Timepoint: 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.

Countries

India, Malawi

Contacts

Public ContactDr Manisha Kumar

Lady Hardinge Medical College

manishaonly@gmail.com9818014887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026