Trials / Unknown
UnknownNCT03767803
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 344 (estimated)
- Sponsor
- Progenity, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Pre-Eclampsia
- Hypertension
- Proteinuria in Pregnancy
- Thrombocytopenia
- Renal Insufficiency
- Impaired Liver Function
- Pulmonary Edema
- Headache
- Visual Impairment
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Non-interventional study | This is an observational, non-interventional study. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2018-12-07
- Last updated
- 2020-01-23
Locations
24 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03767803. Inclusion in this directory is not an endorsement.