Pancreatic Stone Protein (PSP) in Pregnant Women

Last updated: November 23, 2018
Sponsor: Nicole Ochsenbein
Overall Status: Active - Recruiting

Phase

N/A

Condition

Preeclampsia

Pregnancy

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT02247297
KEK-ZH-Nr. 2014-0046
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years

  • Healthy women with single pregnancy

  • Women with PPROM, AIS, preeclampsia, or HELLP syndrome

  • Patients able to provide informed consent

Exclusion

Exclusion Criteria:

  • Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) orconfirmed bacterial infections

Study Design

Total Participants: 486
Study Start date:
September 01, 2014
Estimated Completion Date:
September 30, 2019

Study Description

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.

Connect with a study center

  • University Hospital Zurich

    Zurich, 8091
    Switzerland

    Active - Recruiting

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