Soluble fms-like tyrosine kinase 1 (sFlt-1), Placental Growth Factor

Sponsor

Ortho-Clinical Diagnostics

Principal Investigator

Dr. John Thorp, Obstetrics and Gynecology

Project Run Dates

1/4/2008 to 12/31/2009

Total Award Amount

$115,139.41

 

Summary

 Preeclampsia is a multisystem disorder that complicates approximately 5-7% of all pregnancies. It is diagnosed by appearance of hypertension, protein excretion urine, symptoms like headache, visual disturbance, epigastric pain and rarely by the life threatening HELLP syndrome (hemolysis, elevated liver enzymes and low platelets).The etiology of preeclampsia is not completely understood but the most plausible hypothesis gives the placenta a central role in the pathogenesis of preeclampsia. The hypothesis of this study is that alterations in serum angiogenic factors precede the onset of preeclampsia before overt disease occurs, that angiogenic factors can help diagnose preeclampsia before the symptoms occur and patients can be risk stratified based on these measurements. The purpose of the study is to collect data to support an in vitro diagnostic device, IVDD that can accurately predict preeclampsia prior to onset of signs and symptoms in pregnant women and aid in the diagnosis of preeclampsia. The other objectives are to assess the biomarkers’ ability to stratify patients at risk of preeclampsia and to expand a sample bank for future use in the development and validation of research methods, biomarkers, diagnostic tools, therapeutic agents and clinical assays for obstetric disease. Participants: This is a prospective, multicenter, observational, non-significant risk clinical study of approximately 1000 pregnant women, at a high risk of developing preeclampsia. Subjects will be recruited from approximately 25 sites in the North America. Procedures (methods): Subjects will be screened and informed consent obtained when eligibility criteria are satisfied. The study subjects will have 6 visits with qualified staff that will clinically assess the subjects at each visit, and obtain serial blood and midstream urine samples. The visits will be scheduled 4-5 weeks apart starting from the 10 to 16 weeks of pregnancy and the last one at delivery.

 

Associated Publications and other materials

 

Associated Award Numbers: A08-1092-002, A08-1092-003, A08-1092-004, A08-1092-005, A08-1092-006, A08-1092-007, A08-1092-008, A08-1092-009, A08-1092-010, A08-1092-011