Plasma Concentration of Biological Markers in Placenta Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Determine the level of placental-derived MPs (Microparticles/mL)
研究概览
简要总结
The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.
详细描述
Maternal blood samples will be taken at various points during the intrapartum 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 The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.
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
- 是
入选标准
- •Age 18 - to 45-years old, inclusive
- •Suspected or confirmed PAS or phenotypically matched controls
- •Delivery by cesarean section
- •Gestational age greater than 28 weeks
- •Singleton pregnancy
排除标准
- •Intrauterine fetal demise,
- •Severe fetal anomalies (infant not expected to survive)
- •Emergent cesarean delivery
结局指标
主要结局
Determine the level of placental-derived MPs (Microparticles/mL)
时间窗: Up to 6 hours
Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
Identify biomarkers (picogram/mL)
时间窗: Up to 6 hours
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
次要结局
- Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.(Up to 6 hours)