Headache, Hypertension, Impaired Liver Function, Pre-Eclampsia, Proteinuria in Pregnancy, Pulmonary Edema, Renal Insufficiency, Thrombocytopenia, Visual Impairment
Conditions
Keywords
Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema, Cerebral Symptoms, Visual Symptoms
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 care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as outpatient centers, clinic sites, and medical offices. Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Interventions
OTHERNon-interventional study
This is an observational, non-interventional study.
Sponsors
Progenity, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of preeclampsia is determined by standard of care. | 3 months | Observational, non-interventional sample procurement study in which participants are treated per standard of care |
Countries
United States
Outcome results
None listed