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NCT03815110 · ClinicalTrials.gov registry record
Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 1,050
- Enrollment target
NCT03815110: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT03815110 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 1,050 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815110 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 1,050 participants
- Enrollment target
Study Summary
The purpose of this study is to 1. Identify a cut-off for the ratio of the serum proteins soluble FMS-like Tyrosine Kinase 1 (sFLT-1) and placental growth factor (PlGF) that identifies women will who develop preeclampsia with severe features within 2 weeks of testing (clinically positive) from those who do not develop preeclampsia with severe features within 2 weeks of testing (clinically negative) among preterm pregnant women with hypertensive disorders of pregnancy. And 2. To validate the cut-off the ratio of sFLT-1 and PlGF and to validate the performance of the automated assays used to find the cut-off. Test performance includes positive predictive value, negative predictive value, sensitivity, and specificity. Subjects will provide blood, urine, and saliva samples at the time of enrollment. Samples will be frozen for batch assessment of sFLT-1 and PlGF levels by automated assays. Clinicians, subjects, and researchers will be blinded to protein level assessment, therefore assay results will not affect clinical management.
Primary Outcome
Identification of the cut-off and performance (sensitivity, specificity, positive predictive value, and negative predictive value) for the sFLT-1/PlGF ratio as determined by automated assays that enable differentiation of those women with a hypertensive disorder of pregnancy who develop preeclampsia with severe features from those who do not develop preeclampsia within 2 weeks of testing.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,050 participants |
| Start Date | 2018-12-20 |
| Est. Completion | 2022-10-01 |
What the finished NCT03815110 record still lists
NCT03815110 is an observational study that tracks outcomes without assigning an intervention. Its 1,050 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03815110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815110 about?
NCT03815110 is a clinical study titled "Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification". The purpose of this study is to 1. Identify a cut-off for the ratio of the serum proteins soluble FMS-like Tyrosine Kinase 1 (sFLT-1) and placental growth factor (PlGF) that identifies women will who develop preeclampsia with severe features within 2 weeks of testing (clinically positive) from thos...
What is the current status of trial NCT03815110?
This trial is currently completed. The enrollment target is 1,050 participants. The study started on 2018-12-20. Estimated completion is 2022-10-01.
Who is sponsoring clinical trial NCT03815110?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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