Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Physiological course of PSP in healthy pregnant women
研究概览
简要总结
This prospective, single centred cohort study evaluates the physiological course of the potentially novel biomarker PSP in pregnant women as well as its predictive role in the development of inflammatory complications during pregnancy.
详细描述
Pregnant women feature a complex immunological condition caused by pregnancy itself and hence women present with an increased susceptibility to some infectious and non-infectious inflammatory diseases. Specifically regulated mechanisms have been described occurring in normal whereas lacking in pathological pregnancies in both the native and adaptive immune system in animal models and humans. However, clinically relevant biomarker associated with preterm premature rupture of membranes (PPROM), amniotic infection syndrome (AIS) as well as pregnancy associated complications such as preeclampsia and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome have their limitations.
Pancreatic stone protein (PSP), originally obtained from human pancreatic stones from patients operated for chronic calcifying pancreatitis, has been studied in several gastrointestinal pathologies.
The aim of this study is to evaluate the physiological course of the potentially novel biomarker PSP in pregnant women as well as to assess its predictive role in the development of inflammatory complications during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age > 18 years
- •Healthy women with single pregnancy
- •Women with PPROM, AIS, preeclampsia, or HELLP syndrome
- •Patients able to provide informed consent
排除标准
- •Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or confirmed bacterial infections
结局指标
主要结局
Physiological course of PSP in healthy pregnant women
时间窗: 34 weeks
Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
次要结局
- Predictive role of PSP in the development of complications during pregnancy(34 weeks)
研究者
Nicole Ochsenbein
Prof. Dr. med.
University of Zurich
