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临床试验/NCT03932877
NCT03932877已完成不适用

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

Cengiz Gokcek Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
Serum matrix metalloproteinase-14 levels in preeclampsia

研究概览

简要总结

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 To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished.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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • preeclampsia
  • healthy pregnancy

排除标准

  • 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

结局指标

主要结局

Serum matrix metalloproteinase-14 levels in preeclampsia

时间窗: 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.

次要结局

  • Serum soluble endoglin levels in preeclampsia(1 day)

研究者

发起方
Cengiz Gokcek Women's and Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Ovayolu

Principal Investigator

Cengiz Gokcek Women's and Children's Hospital

研究点 (1)

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