Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification

Completed

Conditions studied: Preeclampsia and Eclampsia, Preeclampsia Severe, Gestational Hypertension, Chronic Hypertension in Obstetric Context, Superimposed Pre-Eclampsia, Preeclampsia Mild

In brief

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.

Key facts

Study ID

NCT03815110

Run by

Cedars-Sinai Medical Center

People needed

1050

Starts

2018-12-20

Expected to finish

2022-10-01

Last updated by the study team

2022-11-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent in a pregnant woman ≥ 18 years of age.
• Gestational age 23+0 to 34+6/7 weeks
• Singleton pregnancy
• Hospitalized with (or develop while hospitalized) a hypertensive disorder of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia or gestational hypertension) as defined by ACOG guidelines.

You may not qualify if…

• 1. Patients who have received intravenous heparin within 24 hours of enrollment. Low dose subcutaneous heparin or low molecular weight heparin (LMWH) for prophylaxis of deep venous thrombosis (DVT) is permitted.
• Patients who are currently participating in another clinical trial to evaluate a new therapeutic intervention or who have participated in another such trial in the previous 30 days.
• Multiple gestations.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• UC San Francisco Medical Center — San Francisco, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• University of South Florida — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Northshore — Evanston, Illinois, United States
• MedStar Health — Baltimore, Maryland, United States
• Johns Hopkins University Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of North Carolina Medical Center- Chapel Hill — Chapel Hill, North Carolina, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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