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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Nicole Ochsenbein | University of Zurich |
Switzerland,
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
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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