Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 344
- 试验地点
- 24
- 主要终点
- Diagnosis of preeclampsia is determined by standard of care.
研究概览
简要总结
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diagnosis of preeclampsia is determined by standard of care.
时间窗: 3 months
Observational, non-interventional sample procurement study in which participants are treated per standard of care
次要结局
未报告次要终点