Serum Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in Early/Late-onset Preeclampsia

NCT03932877 | Completed

• 1 other identifier: CengizGWCH3
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished. This study aims to investigate the value of serum MMP-14 and soluble endoglin (s-ENG) in PrE patients and healthy controls. Methods: The study was conducted with 30 late-onset preeclampsia patients (L-PrE) as group1 (gestational age≥34 weeks), 33 patients with normal pregnancies as group2 (gestational age≥34 weeks), 31 early-onset preeclampsia patients (E-PrE) as group3 (gestational age\<34 weeks), and 31 patients with normal pregnancies as group 4 (gestational age\<34 weeks). Serum MMP-14 and s-ENG levels measured by ELISA were compared.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Serum matrix metalloproteinase-14 levels in preeclampsia

  The primary endpoint in this analysis is to evaluate the value of serum matrix metalloproteinase-14 levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.

  1 day

Secondary Outcomes (1)

• Serum soluble endoglin levels in preeclampsia

  1 day

Study Arms (4)

late-onset preeclampsia, group1

30 late-onset preeclampsia patients as group1 (gestational age≥34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg will consider mild, and higher values will consider to being severe.

Other: MMP-14 and s-ENG levels

Control, group 2

33 patients with normal pregnancies as group2 (gestational age≥34 weeks). 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: MMP-14 and s-ENG levels

early-onset preeclampsia, group 3

31 early-onset preeclampsia patients as group3 (gestational age\<34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg considered mild, and higher values considered to being severe.

Other: MMP-14 and s-ENG levels

Control, group 4

31 patients with normal pregnancies as group 4 (gestational age\<34 weeks). 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: MMP-14 and s-ENG levels

Interventions

MMP-14 and s-ENG levels OTHER

Venous blood sampled from the antecubital veins for measuring the serum concentration of MMP-14 and s-ENG levels. The serum MMP-14 and s-ENG levels measured using commercially available reagent kits, which is produced to detect human MMP-14 and s-ENG levels (Rel Assay Diagnostics Gaziantep, Turkey). The MMP-14 and s-ENG levels measurements were performed in accordance with the company's protocol.

Control, group 2; Control, group 4; early-onset preeclampsia, group 3; late-onset preeclampsia, group1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnancy. Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal. Early-onset preeclampsia is usually defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will recruite 61 subjects with preeclampsia, and 64 healthy preganancies will selecte for the control group. Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal. Early-onset preeclampsia is usually defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.

You may qualify if:

• preeclampsia
• healthy pregnancy

You may not qualify if:

• pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
• women with a history of drug use throughout pregnancy
• history of medication for PE treatment at the time of first admission
• patients who had fetal congenital abnormalities or genetic syndromes
• multiple gestations
• active labour

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, Turkey (Türkiye)

Location

Related Publications (4)

• Zhang XH, Zhang HY, Lu S, Jiang LL, Wu J, Yang YL, Zhang SA. MMP-14 aggravates onset of severe preeclampsia by mediating soluble endoglin release. Eur Rev Med Pharmacol Sci. 2018 Mar;22(5):1209-1215. doi: 10.26355/eurrev_201803_14460.

  PMID: 29565476 RESULT

• Espino Y Sosa S, Flores-Pliego A, Espejel-Nunez A, Medina-Bastidas D, Vadillo-Ortega F, Zaga-Clavellina V, Estrada-Gutierrez G. New Insights into the Role of Matrix Metalloproteinases in Preeclampsia. Int J Mol Sci. 2017 Jul 20;18(7):1448. doi: 10.3390/ijms18071448.

  PMID: 28726716 RESULT

• Kaitu'u-Lino TJ, Palmer KR, Whitehead CL, Williams E, Lappas M, Tong S. MMP-14 is expressed in preeclamptic placentas and mediates release of soluble endoglin. Am J Pathol. 2012 Mar;180(3):888-894. doi: 10.1016/j.ajpath.2011.11.014. Epub 2012 Jan 31.

  PMID: 22296769 RESULT

• Ovayolu A, Karaman E, Turgut A, Cekici Y, Ortabag T, Chiara Rapisarda AM, Noventa M, Cianci A. Endothelial cell-specific-molecule-1 (endocan) levels in women with premature ovarian insufficiency: a prospective comparative study. J Obstet Gynaecol. 2021 May;41(4):637-641. doi: 10.1080/01443615.2020.1789952. Epub 2020 Aug 18.

  PMID: 32808833 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Matrix Metalloproteinase 14

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Matrix Metalloproteinases, Membrane-Associated; Matrix Metalloproteinases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Ali Ovayolu

  Cengiz Gokcek WCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 1, 2019
• Study Start: January 30, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

TU (1)