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SHD_0274_PE_Pregnant_Healthy_600
seeking healthy pregnant subjects
Take Feasibility Survey
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
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