Preeclamptic Patients and Pentraxin 3 & Lipoprotein-associated Phospholipase A2

Pre-Eclampsia Clinical Trial

Official title:

Levels of Inflammatory and Cardiovascular Risk Markers in Preeclamptic Patients; New Biomarkers: Pentraxin 3 & Lipoprotein-associated Phospholipase A2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239352
• Other study ID #: ATADEK-2020/01
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: May 20, 2020

Study information

• Verified date: May 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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