Pancreatic Stone Protein (PSP) in Pregnant Women

• Conditions: HELLP Syndrome; Pregnancy; Preterm Premature Rupture of Fetal Membranes; Preeclampsia
• Interventions: Procedure: Blood collection

• Registration Number: NCT02247297
• Lead Sponsor: Nicole Ochsenbein

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-23
• Last Update Posted: 2018-11-26
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 486

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women	Blood collection	Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes

Primary Outcome Measures

Name	Time	Method
Physiological course of PSP in healthy pregnant women	34 weeks	Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)

Secondary Outcome Measures

Name	Time	Method
Predictive role of PSP in the development of complications during pregnancy	34 weeks	Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland