PregnancyNCT02247297
Pancreatic Stone Protein (PSP) in Pregnant Women
An observational study of Pregnancy and HELLP Syndrome, run by Nicole Ochsenbein at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, HELLP Syndrome, Preterm Premature Rupture of Fetal Membranes
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 486 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome, or PPROM)
Who may be able to join
- Age > 18 years
- Healthy women with single pregnancy
- Women with PPROM, AIS, preeclampsia, or HELLP syndrome
- Patients able to provide informed consent
Who cannot join
- Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or confirmed bacterial infections
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Nicole Ochsenbein, Prof. Dr., +41 (0) 44 255 11 11, nicole.ochsenbein@usz.ch
Nora Gadient, Dr. med., +41 (0) 44 255 11 11, nora.gadient@usz.ch
About this study
Official title: Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy
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.
Read the 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.
- Being tested
- Blood collection
- Keywords
- Pancreatic stone protein (PSP), premature rupture of membranes (PPROM), amniotic infection syndrome (AIS), hemolysis, elevated liver enzymes, and low platelets (HELLP), preeclampsia, pregnancy
- Medical subject headings
- HELLP Syndrome, Fetal Membranes, Premature Rupture, Pre-Eclampsia, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Diagnostic blood collection
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological course of PSP in healthy pregnant women
Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
Measured: 34 weeks
Secondary outcomes (1)
Predictive role of PSP in the development of complications during pregnancy
Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Ochsenbein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Nicole Ochsenbein, University of Zurich
- Investigators
- Nicole Ochsenbein, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247297
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0046
- Status last verified
- Nov 2018
- First submitted
- 17 Sep 2014
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
De Caro A, Lohse J, Sarles H. Characterization of a protein isolated from pancreatic calculi of men suffering from chronic calcifying pancreatitis. Biochem Biophys Res Commun. 1979 Apr 27;87(4):1176-82. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.
PubMed 111670Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
PubMed 16360171Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.
PubMed 19325491Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.
PubMed 21835904Que YA, Delodder F, Guessous I, Graf R, Bain M, Calandra T, Liaudet L, Eggimann P. Pancreatic stone protein as an early biomarker predicting mortality in a prospective cohort of patients with sepsis requiring ICU management. Crit Care. 2012 Jul 2;16(4):R114. doi: 10.1186/cc11406.
PubMed 22748193
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy
- ClinicalTrials.gov ID
- NCT02247297
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0046
- Keywords
- Pancreatic stone protein (PSP), premature rupture of membranes (PPROM), amniotic infection syndrome (AIS), hemolysis, elevated liver enzymes, and low platelets (HELLP), preeclampsia, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Nicole OchsenbeinUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Sep 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Procedure: Blood collectionHealthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome, or PPROM)
Key inclusion criteria (4 listed)
- Age > 18 years
- Healthy women with single pregnancy
- Women with PPROM, AIS, preeclampsia, or HELLP syndrome
- Patients able to provide informed consent
Key exclusion criteria (1 listed)
- Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or confirmed bacterial infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionDiagnostic blood collection | Procedure or surgery | Pregnant Women |
Primary outcome
Physiological course of PSP in healthy pregnant women
Time frame: 34 weeks
Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
1 secondary outcome
Predictive role of PSP in the development of complications during pregnancy
Time frame: 34 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Results publication: PubMed 111670De Caro A, Lohse J, Sarles H. Characterization of a protein isolated from pancreatic calculi of men suffering from chronic calcifying pancreatitis. Biochem Biophys Res Commun. 1979 Apr 27;87(4):1176-82. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.
- Results publication: PubMed 16360171Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
- Results publication: PubMed 19325491Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.
- Results publication: PubMed 21835904Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.
- Results publication: PubMed 22748193Que YA, Delodder F, Guessous I, Graf R, Bain M, Calandra T, Liaudet L, Eggimann P. Pancreatic stone protein as an early biomarker predicting mortality in a prospective cohort of patients with sepsis requiring ICU management. Crit Care. 2012 Jul 2;16(4):R114. doi: 10.1186/cc11406.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Ochsenbein, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and HELLP Syndrome, run by Nicole Ochsenbein at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Ochsenbein, Prof. Dr. (+41 (0)44 255 11 11, nicole.ochsenbein@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological course of PSP in healthy pregnant women (time frame: 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247297, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.