Pancreatic Stone Protein (PSP) in Pregnant Women

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Blood collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes | Procedure: Blood collection<br>* Diagnostic blood collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological course of PSP in healthy pregnant women | Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay) | 34 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive role of PSP in the development of complications during pregnancy | Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay) | 34 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, Pancreatic stone protein (PSP), premature rupture of membranes (PPROM), amniotic infection syndrome (AIS), hemolysis, elevated liver enzymes, and low platelets (HELLP), pregnancy