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Pancreatic Stone Protein (PSP) in Pregnant Women

N

Nicole Ochsenbein

Status

Unknown

Conditions

Preeclampsia
Preterm Premature Rupture of Fetal Membranes
HELLP Syndrome
Pregnancy

Treatments

Procedure: Blood collection

Study type

Observational

Funder types

Other

Identifiers

NCT02247297
KEK-ZH-Nr. 2014-0046

Details and patient eligibility

About

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.

Full 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.

Enrollment

486 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

486 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Nora Gadient, Dr. med.; Nicole Ochsenbein, Prof. Dr.

Data sourced from clinicaltrials.gov

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