Plasma Concentration of Biological Markers in Placental Abruption
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Determine the level of placental-derived MPs (Microparticles/mL)
研究概览
简要总结
This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.
详细描述
The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 - to 45-years old, inclusive
- •Suspected or confirmed PA or phenotypically matched controls
- •All modes of delivery
- •Gestational age greater than 28 weeks
- •Singleton pregnancy
排除标准
- •Intrauterine fetal demise,
- •Severe fetal anomalies (infant not expected to survive)
- •Inability to communicate in English
结局指标
主要结局
Determine the level of placental-derived MPs (Microparticles/mL)
时间窗: Up to 75 minutes
Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.
Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)
时间窗: Up to 75 minutes
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.
次要结局
- Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.(Up to 75 minutes)