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临床试验/NCT06481683
NCT06481683已完成不适用

Evaluation of Maternal Serum Stathmin-1 Levels as a Biomarker in Preeclampsia and Severe Preeclampsia

Burak Yücel Special Clinic1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月1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
80
试验地点
1
主要终点
Maternal Serum Stathmin-1 Levels

研究概览

简要总结

The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations.

The main questions it aims to answer are:

  1. What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
  2. How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?

Researchers will compare Stathmin-1 levels in pregnancies with preeclampsia and preeclampsia with severe features to those in a control group of healthy pregnancies to assess differences in biomarker levels.

Participants will undergo blood sample collection at 32-34 weeks of gestation. Have their blood samples processed for Stathmin-1 level measurement using ELISA.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational Age: Pregnancies between 20 weeks and term (up to 40 weeks).
  • Diagnosis of Preeclampsia (PE): New-onset hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
  • Diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
  • Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.

排除标准

  • Multiple Pregnancies: Participants carrying more than one fetus.
  • Pregestational Diabetes: Pre-existing diabetes mellitus diagnosed before pregnancy.
  • Chronic Hypertension: Pre-existing hypertension diagnosed before pregnancy or before 20 weeks of gestation.
  • Systemic Diseases: Chronic kidney disease, autoimmune diseases, or other significant systemic illnesses.
  • Fetal Anomalies: Identified structural or genetic abnormalities in the fetus.
  • Premature Rupture of Membranes: Spontaneous rupture of membranes before the onset of labor at term (37 weeks of gestation) or preterm (before 37 weeks of gestation).

结局指标

主要结局

Maternal Serum Stathmin-1 Levels

时间窗: Measured at the time of diagnosis and followed up until delivery.

To identify and compare Maternal Serum Stathmin-1 Levels levels between the pre-eclampsia group, severe pre-eclampsia group, and the control group. This will help in understanding the biochemical environment associated with pre-eclampsia and its severity.

次要结局

未报告次要终点

研究者

发起方
Burak Yücel Special Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Yücel

Assoc. Professor

Burak Yücel Special Clinic

研究点 (1)

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