Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia

NCT04126902 | Completed

• 1 other identifier: CengizGWCH5
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

innate immunity; macrophage; toll-like receptors; trophoblasts; phagocytos

Outcome Measures

Primary Outcomes (1)

• The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.

  The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.

  3 months

Study Arms (2)

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.

Other: interleukin-6, presepsin and pentraxin-3

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.

Other: interleukin-6, presepsin and pentraxin-3

Interventions

interleukin-6, presepsin and pentraxin-3 OTHER

measurements and compare

Control; late-onset preeclampsia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnancy- preeclampsia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy pregnancies selected for the control group.

You may qualify if:

• preeclampsia healthy pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26104418 BACKGROUND

• 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.

  PMID: 24150027 BACKGROUND

• 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.

  PMID: 19452432 RESULT

• 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.

  PMID: 26720209 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Interleukin-6; PTX3 protein

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ali Ovayolu, MD

  Cengiz Gokcek WCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: June 6, 2018
• Primary Completion: January 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

TU (1)