Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women

Study Overview
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Brief Summary
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Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.

Detailed Description
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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.

Official Title
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Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers

Conditions
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Pulmonary Edema, Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Headache, Visual Impairment

Intervention / Treatment
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* Other: Non-interventional study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive Preeclampsia group<br>A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery | Other: Non-interventional study<br>* This is an observational, non-interventional study.<br>|
| Study Cohort<br>A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery. | Other: Non-interventional study<br>* This is an observational, non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of preeclampsia is determined by standard of care. | Observational, non-interventional sample procurement study in which participants are treated per standard of care | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema, Cerebral Symptoms, Visual Symptoms