Clinical trial NCT02247297: Pancreatic Stone Protein (PSP) in Pregnant Women
Official title: Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
HELLP Syndrome
Preterm Premature Rupture of Fetal Membranes
Preeclampsia
Keywords: Pancreatic stone protein (PSP)
premature rupture of membranes (PPROM)
amniotic infection syndrome (AIS)
hemolysis, elevated liver enzymes, and low platelets (HELLP)
preeclampsia
pregnancy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2014-09-25
Enrollment: 486
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome, or PPROM)

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological course of PSP in healthy pregnant women
timeFrame: 34 weeks
Secondary outcomes:
measure: Predictive role of PSP in the development of complications during pregnancy
timeFrame: 34 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Nicole Ochsenbein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.
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. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
citation: 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.
citation: 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.
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):R114. doi: 10.1186/cc11406.