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A test for screening Preeclampsia early in pregnancy: A Study Across Multiple Hospitals

A Prospective Multicentric Performance Evaluation study for a rapid Preeclampsia screening test - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093346
Enrollment
800
Registered
2025-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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 Intervention4: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women having gestational age between 11 to 16 weeks from LMP and/or CRL

Exclusion criteria

Exclusion criteria: Unconscious or severely ill status Having major fetal abnormality identified at the time of enrollment Known bleeding disorder such as von Willebrand?s disease Participation in another drug trial within 28 days before screening Pregnant women diagnosed with Preeclampsia Pregnant women who are already on aspirin medication Pregnant women with a known case of diabetes or chronic HTN Twins or multiple pregnancies

Design outcomes

Primary

MeasureTime frame
To evaluate the Diagnostic Accuracy of the Preeclampsia screening testTimepoint: At 6 time points of testing during the study (gestational age) 1. 11 to 12 weeks ? 6 days 2. 13 to 15 weeks ? 6 days 3. 16 to 19 weeks ? 6 days 4. 20 to 28 weeks ? 6 days 5. 28 to 34 weeks ? 6 days 6. after 35 weeks ? 0 days

Secondary

MeasureTime frame
Using patient history and other clinical findings (MAP, USG findings, maternal factors) and combinations for enhanced diagnostic accuracyTimepoint: 6 time points;Association of risk factors with PreeclampsiaTimepoint: 6 time points

Countries

India

Contacts

Public ContactDr Neha Lasure

Intignus Biotech Pvt Ltd

nehalasure@intignusbiotech.com9923141484

Outcome results

None listed

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