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NCT02247297 Clinical Trial

Pancreatic Stone Protein (PSP) in Pregnant Women

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02247297
Other study ID # KEK-ZH-Nr. 2014-0046
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2014
Est. completion date September 2019

Study information
Verified date November 2018
Source University of Zurich
Contact Nicole Ochsenbein, Prof. Dr.
Phone +41 (0)44 255 11 11
Email nicole.ochsenbein@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 486
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Criteria:

- Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or confirmed bacterial infections

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood collection
Diagnostic blood collection

Locations
Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (2)
Lead Sponsor Collaborator
Nicole Ochsenbein University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.13 — View Citation

De Caro A, Lohse J, Sarles H. Characterization of a protein isolated from pancreatic calculi of men suffering from chronic calcifying pancreatitis. Biochem Biophys Res Commun. 1979 Apr 27;87(4):1176-82. — View Citation

Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. Epub 2005 Dec 19. Revie — View Citation

Keel M, Härter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31 — View Citation

Que YA, Delodder F, Guessous I, Graf R, Bain M, Calandra T, Liaudet L, Eggimann P. Pancreatic stone protein as an early biomarker predicting mortality in a prospective cohort of patients with sepsis requiring ICU management. Crit Care. 2012 Jul 2;16(4):R1 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Physiological course of PSP in healthy pregnant women Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay) 34 weeks
Secondary Predictive role of PSP in the development of complications during pregnancy Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay) 34 weeks
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