A Nested Case-Controlled Study Evaluating the Utility of Placental Protein 13 (PP13) In-vitro Diagnostic Kit as a Diagnostic Aiding Tool in Assessment of the Risk for Developing Preeclampsia Necessitating Delivery Before 37 Weeks (Early-preeclampsia) Based on First Trimester Blood Testing of Pregnant Women With Low and Unknown Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 431
- 试验地点
- 1
- 主要终点
- Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia
研究概览
简要总结
The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.
详细描述
After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of 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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, pregnant females
- •Singleton fetus at 7 0/7 to 13 6/7 weeks gestation
排除标准
- •Multi-fetal pregnancy
- •Mental retardation
- •Known fetal anomaly or demise
- •BMI > 35, serious medical condition
结局指标
主要结局
Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia
时间窗: 37 Weeks
次要结局
- Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks(34 Weeks, At Delivery)
研究者
Carl Weiner, MD
Professor and Chair, Obstetrics and Gynecology
University of Kansas Medical Center