Status:
UNKNOWN
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Lead Sponsor:
Progenity, Inc.
Conditions:
Pre-Eclampsia
Hypertension
Eligibility:
FEMALE
18-45 years
Brief Summary
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
Detailed Description
This multicenter non-interventional observational sample acquisition study is designed to acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E and are in the ca...
Eligibility Criteria
Inclusion
- Subject is 18 to 45 years of age
- Subject is willing to provide informed consent
- Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
- Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
- Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:
- New onset increased blood pressure in otherwise normotensive patient
- Worsening hypertension in a patient with pre-existing hypertension
- New onset proteinuria or worsening of pre-existing proteinuria
- Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E
Exclusion
- Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT03767803
Start Date
October 1 2018
End Date
December 31 2020
Last Update
January 23 2020
Active Locations (24)
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1
West Coast Medical Research, Inc.
San Diego, California, United States, 92123
2
Christiana Care
Newark, Delaware, United States, 19718
3
Women's Health Partners, LLC
Boca Raton, Florida, United States, 33433
4
Discovery Clinical Research
Plantation, Florida, United States, 33324