NCT04239352

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

January 20, 2020

Last Update Submit

May 21, 2020

Conditions

Keywords

Pentraxin 3Lipoprotein-associated phospholipase A2preeclampsiarisk markers

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.

Diagnostic Test: Pentraxin 3 ; new biomarkerDiagnostic Test: Lipoprotein-associated phospholipase A2 ; new biomarker

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.

Diagnostic Test: Pentraxin 3 ; new biomarkerDiagnostic Test: Lipoprotein-associated phospholipase A2 ; new biomarker

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.

healthy pregnant womenpreeclamptic pregnant women

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.

healthy pregnant womenpreeclamptic pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

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

Locations