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Pancreatic Stone Protein (PSP) in Pregnant Women

Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02247297
Enrollment
486
Registered
2014-09-25
Start date
2014-09-30
Completion date
2019-09-30
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELLP Syndrome, Preeclampsia, Pregnancy, Preterm Premature Rupture of Fetal Membranes

Keywords

Pancreatic stone protein (PSP), premature rupture of membranes (PPROM), amniotic infection syndrome (AIS), hemolysis, elevated liver enzymes, and low platelets (HELLP), preeclampsia, pregnancy

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.

Interventions

PROCEDUREBlood collection

Diagnostic blood collection

Sponsors

University of Zurich
CollaboratorOTHER
Nicole Ochsenbein
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physiological course of PSP in healthy pregnant women34 weeksMeasurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)

Secondary

MeasureTime frameDescription
Predictive role of PSP in the development of complications during pregnancy34 weeksMeasurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)

Countries

Switzerland

Contacts

Primary ContactNicole Ochsenbein, Prof. Dr.
nicole.ochsenbein@usz.ch+41 (0)44 255 11 11
Backup ContactNora Gadient, Dr. med.
nora.gadient@usz.ch+41 (0)44 255 11 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026