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临床试验/NCT02247297
NCT02247297Unknown不适用

Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy

Nicole Ochsenbein1 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2014年9月最近更新:
适应症

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

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

发起方
Nicole Ochsenbein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicole Ochsenbein

Prof. Dr. med.

University of Zurich

研究点 (1)

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