Clinical Trial: Pancreatic Stone Protein (PSP) in Pregnant Women

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Nicole Ochsenbein

Current Primary Outcome: Physiological course of PSP in healthy pregnant women [ Time Frame: 34 weeks ]

Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)


Original Primary Outcome: Same as current

Current Secondary Outcome: Predictive role of PSP in the development of complications during pregnancy [ Time Frame: 34 weeks ]

Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: September 17, 2014
Date Started: September 2014
Date Completion: September 2017
Last Updated: June 22, 2016
Last Verified: June 2016