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Trial record 51 of 56 for:    severe preeclampsia AND weeks of gestation

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

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ClinicalTrials.gov Identifier: NCT04126902
Recruitment Status : Completed
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital

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.


Condition or disease Intervention/treatment
Preeclampsia Other: interleukin-6, presepsin and pentraxin-3

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia
Actual Study Start Date : June 6, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
measurements and compare

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
measurements and compare




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy- preeclampsia
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy pregnancies selected for the control group.
Criteria

Inclusion Criteria:

  • preeclampsia healthy pregnancy

Exclusion Criteria:

  1. pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
  2. using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
  3. pregnant women who had fever at the time of the first admission,
  4. concurrent infections (urinary tract infection, cervicitis, etc.),
  5. pregnancies complicated with premature membrane rupture or chorioamnionitis,
  6. history of medication for PE treatment at the time of the first admission,
  7. patients who had fetal congenital abnormalities or genetic syndromes,
  8. drug user,
  9. multiple gestations,
  10. active labor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126902


Locations
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Turkey
Cengiz Gokcek Women's and Child's hospital
Gaziantep, Turkey, 27010
Sponsors and Collaborators
Cengiz Gokcek Women's and Children's Hospital
Investigators
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Principal Investigator: Ali Ovayolu, MD Cengiz Gokcek WCH
  Study Documents (Full-Text)

Documents provided by Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital:

Publications of Results:
Other Publications:
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Responsible Party: Ali Ovayolu, Principal Investigator, Cengiz Gokcek Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04126902     History of Changes
Other Study ID Numbers: CengizGWCH5
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital:
innate immunity
macrophage
toll-like receptors
trophoblasts
phagocytos
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications