Preeclampsia Risk Assessment (PRAECIS)
Condition: Preeclampsia, eclampsia
Key Inclusion Criteria
- Pregnant women who are at least 18 years old, with gestational age 23 – 34 6/7 weeks
- Singleton pregnancy
- Hospitalized with (or develop while hospitalized) a hypertensive disorder of pregnancy
Key Exclusion Criteria
- Patients who have received intravenous heparin within 24 hours of enrollment; low-dose, subcutaneous heparin or low molecular weight heparin for prophylaxis of deep venous thrombosis 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
Full Study Name
Identification and Validation of a Cut-Off for the Ratio of Soluble FMS-Like Tyrosine Kinase-1 to Placental Growth Factor (sFlt-1/PlGF) to Stratify Risk in Pregnant Women With Hypertensive Disorders of Pregnancy (IRB no. 55135)
This study focuses on women with high blood pressure in pregnancy. Researchers aim to identify a protein level in this patient population that will predict who will go on to develop severe features of preeclampsia and its complications. Preeclampsia-eclampsia is one of the leading causes of pregnancy complications and premature delivery in the U.S. The goal is to develop a blood test that will be available in hospitals to help physicians determine who (among women with high blood pressure in pregnancy) will become sick quickly and need specialized care. Urine and saliva protein levels will also be analyzed. The results of protein analyses will not be made available to treating physicians and will not affect participants’ care in any way.
Two tests from BRAHMSGmbH/ThermoFisher will be evaluated. Other companies’ tests may also be assessed. These tests have not been approved by the U.S. Food and Drug Administration (FDA).
Financial disclosure: S. Ananth Karumanchi, MD, the principal investigator, is listed as a co-inventor of patents that have been out-licensed to multiple companies. Also, S. Ananth Karumanchi, MD, has received payment for consultation services provided to Roche Diagnostics and Thermofisher, the companies that make the protein tests being examined in this study.