- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126902
Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia (Presepsin&PE)
Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.
Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaziantep, Turkey, 27010
- Cengiz Gokcek Women's and Child's hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- preeclampsia healthy pregnancy
Exclusion Criteria:
- pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
- using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
- pregnant women who had fever at the time of the first admission,
- concurrent infections (urinary tract infection, cervicitis, etc.),
- pregnancies complicated with premature membrane rupture or chorioamnionitis,
- history of medication for PE treatment at the time of the first admission,
- patients who had fetal congenital abnormalities or genetic syndromes,
- drug user,
- multiple gestations,
- active labor.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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late-onset preeclampsia
The diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman.
The diastolic and/or systolic blood pressure <110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe.
The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group.
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measurements and compare
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Control
The control groups' samples obtained during the routine obstetrical care examination in the third trimester of pregnancy.
Then these pregnant women followed-up until the delivery.
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measurements and compare
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.
Time Frame: 3 months
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The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.
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3 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy (HDP) Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Apr;4(2):105-45. doi: 10.1016/j.preghy.2014.01.003. Epub 2014 Feb 25.
- Canzoneri BJ, Lewis DF, Groome L, Wang Y. Increased neutrophil numbers account for leukocytosis in women with preeclampsia. Am J Perinatol. 2009 Nov;26(10):729-32. doi: 10.1055/s-0029-1223285. Epub 2009 May 18.
- Pugni L, Pietrasanta C, Milani S, Vener C, Ronchi A, Falbo M, Arghittu M, Mosca F. Presepsin (Soluble CD14 Subtype): Reference Ranges of a New Sepsis Marker in Term and Preterm Neonates. PLoS One. 2015 Dec 31;10(12):e0146020. doi: 10.1371/journal.pone.0146020. eCollection 2015.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CengizGWCH5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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