Preeclamptic Patients and Pentraxin 3 & Lipoprotein-associated Phospholipase A2

NCT ID: NCT04239352

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-05-20

Brief Summary

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In particular, pentraxine 3 (PTX3) molecule was assumed to have a prognostic value in acute myocardial infarction.In patients affected by acute myocardial infarction, early plasma elevation of PTX3 appears to predict a worse outcome in these patients in the longer term.

The inflammatory basis of preeclampsia resembles an atherogenic process.It is planned to investigate the role of these two molecules in endothelial dysfunction typical of preeclampsia.

The level of circulating PTX3 and Lp-PLA2 in preeclamptic patients and their serum levels according to the severity of preeclampsia and presence of IUGR, and comparison with the control group without preeclampsia and It is planned to investigate the cut-off values and sensitivity and specificity of both molecules together and separately in preeclampsia.

Detailed Description

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Conditions

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Pre-Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy pregnant women

Blood samples taken from 40 healthy pregnant women will be obtained by taking patient consent forms and storing their serum at -80 degrees. Then, serum Pentraxin 3 and Lp-PLA2 levels will be checked in these blood by ELISA method.

this group will be the control group.

Pentraxin 3 ; new biomarker

Intervention Type DIAGNOSTIC_TEST

Pentraxin (PTX3) is an inflammatory molecule that belongs to a recently identified, well-known C-reactive protein (CRP) family.

PTX3 plasma levels increase in vascular disorders including myocardial infarction and correlate with small vessel vasculitis and outcome or disease activity.

These biological and clinical features of PTX3 have led us to investigate this molecule in preeclampsia, a syndrome characterized by a prominent vascular component.

Lipoprotein-associated phospholipase A2 ; new biomarker

Intervention Type DIAGNOSTIC_TEST

Lp-PLA2 is a recently described and potentially useful plasma biomarker associated with cardiovascular diseases. Because of this effect, we will investigate that preeclampsia also be beneficial.

preeclamptic pregnant women

Blood samples taken from 40 preeclamptic pregnant women will be obtained by taking patient consent forms and storing their serum at -80 degrees. Then, serum Pentraxin 3 and Lp-PLA2 levels will be checked in these blood by ELISA method.

this group will be the study group.

Pentraxin 3 ; new biomarker

Intervention Type DIAGNOSTIC_TEST

Pentraxin (PTX3) is an inflammatory molecule that belongs to a recently identified, well-known C-reactive protein (CRP) family.

PTX3 plasma levels increase in vascular disorders including myocardial infarction and correlate with small vessel vasculitis and outcome or disease activity.

These biological and clinical features of PTX3 have led us to investigate this molecule in preeclampsia, a syndrome characterized by a prominent vascular component.

Lipoprotein-associated phospholipase A2 ; new biomarker

Intervention Type DIAGNOSTIC_TEST

Lp-PLA2 is a recently described and potentially useful plasma biomarker associated with cardiovascular diseases. Because of this effect, we will investigate that preeclampsia also be beneficial.

Interventions

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Pentraxin 3 ; new biomarker

Pentraxin (PTX3) is an inflammatory molecule that belongs to a recently identified, well-known C-reactive protein (CRP) family.

PTX3 plasma levels increase in vascular disorders including myocardial infarction and correlate with small vessel vasculitis and outcome or disease activity.

These biological and clinical features of PTX3 have led us to investigate this molecule in preeclampsia, a syndrome characterized by a prominent vascular component.

Intervention Type DIAGNOSTIC_TEST

Lipoprotein-associated phospholipase A2 ; new biomarker

Lp-PLA2 is a recently described and potentially useful plasma biomarker associated with cardiovascular diseases. Because of this effect, we will investigate that preeclampsia also be beneficial.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* pregnant women diagnosed with preeclampsia; The blood pressure and proteinuria (at least ≥ 300 mg in urine for 24 hours) will be established before the 20th week of gestation in normotensive pregnancies with an interval of 6 hours.
* Those who have Grand mal convulsions; other causes of convulsions and exclusion of coma were defined as having seizures for the first time after 20 weeks of gestation and 48-72 hours after delivery.
* The diagnosis of HELLP syndrome will be confirmed by intravascular hemolysis. (Abnormal peripheral smear and / or abnormal bilirubin values), high liver enzymes (high serum aspartate transaminase levels \[AST\], alanine transferase \[ALT\] and lactate dehydrogenase \[LDH\] üst 2 upper level) and low platelet count (\<100 000 / mm3)
* healthy pregnant women without additional disease for the control group

Exclusion Criteria

* Maternal diabetes
* Kidney disease
* Cardiovascular disease
* Neurological disease
* drug use history
* Hematological and immunological disease
* The presence of any infection
* Fetal anomaly
* In utero dead fetus
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Kadirogulları

principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ATADEK-2020/01

Identifier Type: -

Identifier Source: org_study_id

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