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NCT Number: NCT04126902

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

About this study

This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interleukin-6, presepsin and pentraxin-3

Other

measurements and compare

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.

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Cengiz Gokcek Women's and Children's Hospital

Other

Registry information

Acronym: Presepsin&PE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2019
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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