NCT02808494已完成不适用
Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 10
- 主要终点
- cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
研究概览
简要总结
Sample Collection Study
详细描述
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older at enrollment
- •Pregnant women with a viable singleton gestation
- •Able to provide written, informed consent
- •Able to provide 20 mL of whole blood
- •Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
- •Preeclampsia with severe features is defined as:
- •Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine >1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
- •Fetal Growth Restriction defined as:
- •Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio >95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
- •Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines
- •A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.
排除标准
- •Known malignancy
- •History of maternal organ or bone marrow transplant
- •Maternal blood transfusion in the last 8 weeks
- •Chronic hypertension diagnosed prior to current pregnancy
- •Type I, II or gestational diabetes
- •Fetal anomaly or known chromosome abnormality
- •Active labor
结局指标
主要结局
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (10)
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