Health Condition 1: O14- Pre-eclampsia
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Lady Hardinge Medical College