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A clinical trial to compare performance of a preeclampsia screening test in pregnant women with preeclampsia and healthy pregnant women

A Clinical Performance Evaluation Case-Control Study for Point-of-Care Preeclampsia Screening Kit in Pregnant Women - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070822
Enrollment
200
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: NOT APPLICABLE Control Intervention1: NIL: NOT APPLICABLE

Sponsors

Intignus Biotech Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases- Pregnant women aged 18 years and above with confirmed diagnosis of preeclampsia based on ACOG guidelines Controls- Age and time-matched normotensive pregnant women aged 18 years and above

Exclusion criteria

Exclusion criteria: Patients meeting any of the following exclusion criteria will not be eligible for participation in this study: 1. Unconscious or severely ill status 2. Having major fetal abnormality identified at the time of enrollment 3. Known bleeding disorder such as von Willebrand’s disease, peptic ulceration 4. Participation in another drug trial within 28 days before screening 5. Unable to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity, positive/negative predictive values of Preeclampsia Screening KitTimepoint: Single Time Point

Secondary

MeasureTime frame
1. Correlation of risk factor assessment between cases and controls 2. Comparison of biomarker levels detected by Preeclampsia Screening Kit and reference ELISA Timepoint: Single Time Point

Countries

India

Contacts

Public ContactDr Neha Lasure

Intignus Biotech Pvt. Ltd.

nehalasure@intignusbiotech.com64011026

Outcome results

None listed

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