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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03932877
Enrollment
125
Registered
2019-05-01
Start date
2018-01-30
Completion date
2018-12-30
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

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 To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished.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

Detailed 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.

Interventions

OTHERMMP-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.

Sponsors

Cengiz Gokcek Women's and Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum matrix metalloproteinase-14 levels in preeclampsia1 dayThe 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.

Secondary

MeasureTime frameDescription
Serum soluble endoglin levels in preeclampsia1 dayThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026