Pancreatic Stone Protein (PSP) in Pregnant Women

NCT ID: NCT02247297

Last Updated: 2018-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Pregnancy HELLP Syndrome Preterm Premature Rupture of Fetal Membranes Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes

Blood collection

Intervention Type PROCEDURE

Diagnostic blood collection

Interventions

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Blood collection

Diagnostic blood collection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Nicole Ochsenbein

OTHER

Sponsor Role lead

Responsible Party

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Nicole Ochsenbein

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nicole Ochsenbein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Nicole Ochsenbein, Prof. Dr.

Role: CONTACT

+41 (0)44 255 11 11

Nora Gadient, Dr. med.

Role: CONTACT

+41 (0)44 255 11 11

Facility Contacts

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Nicole Ochsenbein, Prof. Dr.

Role: primary

+41 (0) 44 255 11 11

Nora Gadient, Dr. med.

Role: backup

+41 (0) 44 255 11 11

References

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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.

Reference Type RESULT
PMID: 111670 (View on PubMed)

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.

Reference Type RESULT
PMID: 16360171 (View on PubMed)

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.

Reference Type RESULT
PMID: 19325491 (View on PubMed)

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.

Reference Type RESULT
PMID: 21835904 (View on PubMed)

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.

Reference Type RESULT
PMID: 22748193 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2014-0046

Identifier Type: -

Identifier Source: org_study_id

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