Last updated on January 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Thrombocytopenia | Pre-Eclampsia | Pulmonary Edema | Hypertension | Proteinuria | LIVER DISEASE | Renal Failure
  • Age: Between 18 - 45 Years
  • Gender: Female

Eligibility criteria for the STUDY COHORT (CASES and NEGATIVE PRE-E

CONTROLS):

Inclusion Criteria:

  • Subject is willing to provide informed consent and comply with study procedures
  • 18 to 45 years of age
  • Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (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 either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.

Exclusion Criteria:

  • Pregnancy is non-viable or absence of fetal cardiac activity
  • Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic 160 or diastolic 110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
  • Major fetal anomaly or chromosomal aneuploidy
  • Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis

Eligibility criteria for the POSITIVE CONTROL group:

Inclusion Criteria:

  • Subject is willing to provide informed consent and comply with study procedures
  • 18 to 45 years of age
  • 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 diagnosed with Pre-E using 2013 ACOG guidelines

Exclusion Criteria:

  • Pregnancy is non-viable or absence of cardiac activity
  • Major fetal anomaly or chromosomal aneuploidy
  • Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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