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

Preeclampsia Clinical Trial

Official title:

An Analysis Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in the Diagnosis and Severity of Early/Late-onset Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932877
• Other study ID #: CengizGWCH3
• Status: Completed
• Start date: January 30, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2019
• Source: Cengiz Gokcek Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished.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.

Description:

The study was conducted at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey at department of obstetrics and gynecology between date of January 2018 and December 2018. The study protocol was designed according to the Declaration of Helsinki, and the institutional ethical review board of Gaziantep University approved the study (Reference number: 2018/91). One hundred twenty-five women enrolled in the study in four groups. The investigators consecutively recruited 61 pregnancies complicated with preeclampsia, and 64 healthy pregnancies will select for the control group. All participiants gave their oral and written informed consent before their inclusion in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• preeclampsia

• healthy pregnancy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• MMP-14 and s-ENG levels
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.

Locations

Country	Name	City	State
Turkey	Cengiz Gokcek Women's and Child's hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Cengiz Gokcek Women's and Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Espino Y Sosa S, Flores-Pliego A, Espejel-Nuñez 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). pii: E1448. doi: 10. — View Citation

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):888-94. doi: 10.1016/j.ajpath.2011.11.014. Epub 2012 Jan 31. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum soluble endoglin levels in preeclampsia	The secondary endpoint in this analysis is to evaluate the value of serum soluble endoglin levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.	1 day