Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,730
- 试验地点
- 20
- 主要终点
- Suspected and Pre-E cases determined by institutional standards
研究概览
简要总结
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E.
This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.
详细描述
Eligible subjects will provide written informed consent after which demographic and baseline clinical data will be recorded.
Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
Interim study visits will continue every 14 days [+/- 3 days] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.
In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 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 willing to provide informed consent and comply with study procedures
- •18 to 45 years of age
- •Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (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 either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.
排除标准
- •Pregnancy is non-viable or absence of fetal cardiac activity
- •Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic ≥160 or diastolic ≥110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
- •Major fetal anomaly or chromosomal aneuploidy
- •Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
- •Eligibility criteria for the POSITIVE CONTROL group:
- •Inclusion Criteria:
- •Subject is willing to provide informed consent and comply with study procedures
- •18 to 45 years of age
- •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 diagnosed with Pre-E using 2013 ACOG guidelines
- •Exclusion Criteria:
- •Pregnancy is non-viable or absence of 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
Suspected and Pre-E cases determined by institutional standards
时间窗: about 2 years
次要结局
未报告次要终点