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NCT Number: NCT03932877

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

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 To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished.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

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Cengiz Gokcek Women's and Child's hospital

Gaziantep, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Serum matrix metalloproteinase-14 levels in preeclampsia

    Time frame: 1 day

    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.

Secondary outcomes

  1. Serum soluble endoglin levels in preeclampsia

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Cengiz Gokcek Women's and Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 1, 2019
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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