Pancreatic Stone Protein (PSP) in Pregnant Women

NCT02247297 | Unknown

• 1 other identifier: KEK-ZH-Nr. 2014-0046
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Physiological course of PSP in healthy pregnant women

  Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)

  34 weeks

Secondary Outcomes (1)

• Predictive role of PSP in the development of complications during pregnancy

  34 weeks

Study Arms (1)

Pregnant Women

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

Procedure: Blood collection

Interventions

Blood collection PROCEDURE

Diagnostic blood collection

Pregnant Women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years
• Healthy women with single pregnancy
• Women with PPROM, AIS, preeclampsia, or HELLP syndrome
• Patients able to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Nicole Ochsenbein: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (5)

• 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.

  PMID: 111670 RESULT

• 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.

  PMID: 16360171 RESULT

• 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.

  PMID: 19325491 RESULT

• 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.

  PMID: 21835904 RESULT

• 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.

  PMID: 22748193 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

HELLP Syndrome; Fetal Membranes, Premature Rupture; Pre-Eclampsia; Hemolysis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nicole Ochsenbein, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Ochsenbein, Prof. Dr.

CONTACT

+41 (0)44 255 11 11; nicole.ochsenbein@usz.ch

Nora Gadient, Dr. med.

CONTACT

+41 (0)44 255 11 11; nora.gadient@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

CH (1)