SHD_0274_PE_Pregnant_Healthy_600


seeking healthy pregnant subjects

SHD_0274_Confirmed PE diagnosis (274.2)

Inclusion Criteria
  • 1. >= 18 years of age 2. Pregnant female between 20 to 42 weeks +6 days of gestation 3. Singleton pregnancy 4. Able and willing to provide consent 5. All subjects must be PE diagnosed according to the ACOG criteria listed below as follows: 1. Blood Pressure meeting one of the following criteria: Greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with a previously normal blood pressure
  • Greater than or equal to 160 mmHg systolic or greater than or equal to 110 mmHg diastolic, hypertension can be confirmed within a short interval (minutes) to facilitate timely antihypertensive therapy AND 2. Proteinuria: Greater than or equal to 300 mg per 24-Hour urine collection (or this amount extrapolated from a time collection)
  • Protein/ creatinine ratio greater than or equal to 0.3 mg/dL
  • Dipstick reading of 1 + (used if other quantitative methods not available) 3. In the absence of Proteinuria, new onset of hypertension and one of the following: Thrombocytopenia: Platelet count less than 100,000/microliter
  • Renal Insufficiency: Serum creatinine concentration greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease
  • Impaired Liver Function: Elevated blood concentration of liver transaminase to twice the normal concentration
  • Pulmonary edema
  • Cerebral or visual symptoms
Exclusion Criteria
  • 1. Subjects who have received heparin within 24 hours of enrollment 2. Subjects who received treatment with investigational drug within 90 days before enrollment

SHD_0274_Non-hypertensive healthy pregnant female (274.1)

Inclusion Criteria
  • - At least 18 years of age - Females confirmed to be pregnant between 20 to 42 weeks + 6 days ofo gestation - Singleton pregnancy - Able and willing to provide consent - Blood Pressure (BP)< 140/90 (non-hypertensive) at the time of blood draw
Exclusion Criteria
  • - Females <=18 years of age - Non-pregnant females - Females with a diagnosis of PE, HELLP syndrome, IUGR - Females progressing to a diagnosis of PE after the study blood draw - Any subject not meeting the inclusion criteria - Multiple pregnancies - Subjects who have undergone a heparin treatment within the last 24 hours of enrollment - Subjects who received treatment with investigational drug within 90 days before enrollment

SHD_0274_Pregnant Female (Not Healthy Due to Various Reasons)

Inclusion Criteria
  • At least 18 years of age - Females confirmed to be pregnant between 20-34 weeks of gestation and >=34 of gestation - Singleton pregnancy - Able and willing to provide consent - Blood Pressure (BP)> 140/90 (non-hypertensive) at time of delivery (Preeclampsia diagnosis)
Exclusion Criteria
  • - Females <18 years of age - Non-pregnant females - Females with a diagnosis of PE, chronic or gestational hypertension prior to the study blood draw - Females progressing to a diagnosis of PE after the study blood draw - Any subject not meeting the inclusion criteria - Multiple pregnancies - Subjects who have undergone a heparin treatment within the last 24 hours of enrollment

SHD_0274_Suspected PE (274.3)

Inclusion Criteria
  • 1. >= 18 years of age 2. Singleton pregnancy 3. Female confirmed to be pregnant between 20 to 36 weeks +6 days of gestation 4. Females admitted, referred or self-presented with signs and symptoms suspicious of preeclampsia
  • with an evaluation of PE deemed necessary by a qualified healthcare professional.
Exclusion Criteria
  • 1. Subjects who have received heparin within 24 hours of enrollment 2. Subjects who have a current diagnosis of PE/eclampsia/HELLP/IUGR 3. Subjects who received treatment with investigational drug within 90 days before enrollment