Pancreatic Stone Protein (PSP) in Pregnant Women

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Preeclampsia; HELLP Syndrome; Preterm Premature Rupture of Fetal Membranes
• Intervention / Treatment: Procedure: Blood collection

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 486

Contacts and Locations

• Study Contact: Name: Nicole Ochsenbein, Prof. Dr.; Phone Number: +41 (0)44 255 11 11; Email: nicole.ochsenbein@usz.ch
• Study Contact Backup: Name: Nora Gadient, Dr. med.; Phone Number: +41 (0)44 255 11 11; Email: nora.gadient@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Nicole Ochsenbein, Prof. Dr.; Phone Number: +41 (0) 44 255 11 11; Email: nicole.ochsenbein@usz.ch
    • Contact: Nora Gadient, Dr. med.; Phone Number: +41 (0) 44 255 11 11; Email: nora.gadient@usz.ch
    • Sub-Investigator: Franziska Krähenmann, Dr. med.
    • Sub-Investigator: Roland Zimmermann, Prof. Dr.
    • Sub-Investigator: Rolf Graf, Prof. Dr.
    • Sub-Investigator: Perparim Limani, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome, or PPROM)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Women; Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes	Procedure: Blood collection; Diagnostic blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological course of PSP in healthy pregnant women	Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)	34 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive role of PSP in the development of complications during pregnancy	Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)	34 weeks

Collaborators and Investigators

• Sponsor: Nicole Ochsenbein
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Nicole Ochsenbein, Prof. Dr., University of Zurich

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.
• 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. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
• Keel M, Harter 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.0b013e31819da7d6.
• 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: 10.1378/chest.11-0018. Epub 2011 Aug 11.
• 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):R114. doi: 10.1186/cc11406.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy; preeclampsia; Pancreatic stone protein (PSP); premature rupture of membranes (PPROM); amniotic infection syndrome (AIS); hemolysis, elevated liver enzymes, and low platelets (HELLP)
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Hypertension, Pregnancy-Induced; Rupture; Pre-Eclampsia; HELLP Syndrome; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0046