Preeclamptic Patients and Pentraxin 3 & Lipoprotein-associated Phospholipase A2
Levels of Inflammatory and Cardiovascular Risk Markers in Preeclamptic Patients; New Biomarkers: Pentraxin 3 & Lipoprotein-associated Phospholipase A2
1 other identifier
observational
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2020
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedMay 22, 2020
May 1, 2020
4 months
January 20, 2020
May 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
study group
preeclampsia in pregnant women; in the study group; serum Pentraxin 3 \& Lipoprotein-associated phospholipase A levels It will be investigated whether these parameters observed in pregnant women with preeclampsia vary. Thus, it will be tried to be shown that these new markers may have a place in predicting the risk of preeclampsia
1 week
control group
in healthy pregnant women; in the control group; serum Pentraxin 3 \& Lipoprotein-associated phospholipase A levels The values of these new parameters in healthy pregnants that constitute the control group will be determined and it will be understood whether there is a difference with the pregnants who developed the preeclampsia
1 week
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
blood from 40 healthy pregnant women, 40 preeclamptic pregnant women; Serums will be stored at -80 degrees. Then, serum Pentraxin 3 and Lp-PLA2 levels will be examined in these blood by ELISA method.
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
January 20, 2020
First Posted
January 27, 2020
Study Start
January 20, 2020
Primary Completion
May 20, 2020
Study Completion
May 20, 2020
Last Updated
May 22, 2020
Record last verified: 2020-05