A clinical trial to compare performance of a preeclampsia screening test in pregnant women with preeclampsia and healthy pregnant wome
Not Applicable
- Conditions
- Health Condition 1: O14- Pre-eclampsia
- Registration Number
- CTRI/2024/07/070822
- Lead Sponsor
- Intignus Biotech Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity, positive/negative predictive values of Preeclampsia Screening KitTimepoint: Single Time Point
- Secondary Outcome Measures
Name Time Method 1. Correlation of risk factor assessment between cases and controls <br/ ><br>2. Comparison of biomarker levels detected by Preeclampsia Screening Kit and reference ELISA <br/ ><br>Timepoint: Single Time Point