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Pancreatic Stone Protein (PSP) in Pregnant Women

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ClinicalTrials.gov Identifier: NCT02247297
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Nicole Ochsenbein, University of Zurich

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.

Condition or disease Intervention/treatment
Pregnancy HELLP Syndrome Preterm Premature Rupture of Fetal Membranes Preeclampsia 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.


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Study Type : Observational
Estimated Enrollment : 486 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Physiological course of PSP in healthy pregnant women [ Time Frame: 34 weeks ]
    Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)


Secondary Outcome Measures :
  1. Predictive role of PSP in the development of complications during pregnancy [ Time Frame: 34 weeks ]
    Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome, or PPROM)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247297


Contacts
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Contact: Nicole Ochsenbein, Prof. Dr. +41 (0)44 255 11 11 nicole.ochsenbein@usz.ch
Contact: Nora Gadient, Dr. med. +41 (0)44 255 11 11 nora.gadient@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Nicole Ochsenbein, Prof. Dr.    +41 (0) 44 255 11 11    nicole.ochsenbein@usz.ch   
Contact: Nora Gadient, Dr. med.    +41 (0) 44 255 11 11    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.         
Sponsors and Collaborators
Nicole Ochsenbein
University of Zurich
Investigators
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Principal Investigator: Nicole Ochsenbein, Prof. Dr. University of Zurich

Additional Information:
Publications of Results:
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Responsible Party: Nicole Ochsenbein, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02247297     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0046
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Keywords provided by Nicole Ochsenbein, University of Zurich:
Pancreatic stone protein (PSP)
premature rupture of membranes (PPROM)
amniotic infection syndrome (AIS)
hemolysis, elevated liver enzymes, and low platelets (HELLP)
preeclampsia
pregnancy
Additional relevant MeSH terms:
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Pre-Eclampsia
HELLP Syndrome
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Hypertension, Pregnancy-Induced
Wounds and Injuries