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临床试验/NCT07467226
NCT07467226已完成不适用

THE ROLE OF EARLY SECOND TRİMESTER MATERNAL SERUM CADHERİN-6 LEVELS İNTHE PREDİCTİON OF PREECLAMPSİA

Samsun University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Development of preeclampsia, Diagnosis of preeclampsia defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation accompanied by proteinuria or signs of end-organ dysfunction.

研究概览

简要总结

Preeclampsia is a pregnancy-specific hypertensive disorder that remains one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Despite extensive research, reliable biomarkers for the early prediction of preeclampsia are still limited. Early identification of pregnancies at risk is clinically important because preventive interventions such as low-dose aspirin therapy may reduce the incidence and severity of the disease.

Cadherin-6 (CDH-6) is a calcium-dependent cell adhesion molecule involved in trophoblast invasion and placental development. Abnormal trophoblast differentiation and impaired spiral artery remodeling are key mechanisms implicated in the pathophysiology of preeclampsia. Therefore, molecules involved in placental cell adhesion may have potential as predictive biomarkers for this condition.

This prospective observational cohort study aims to investigate whether maternal serum CDH-6 levels measured during the early second trimester of pregnancy (15-20 weeks of gestation) can predict the subsequent development of preeclampsia. Maternal blood samples collected during routine antenatal screening will be analyzed using an enzyme-linked immunosorbent assay (ELISA) to determine CDH-6 concentrations. Pregnancy outcomes will be evaluated and compared between women who develop preeclampsia and those with uncomplicated pregnancies.

The findings of this study may provide evidence regarding the predictive value of CDH-6 as an early biomarker for preeclampsia and contribute to improved risk stratification and earlier preventive strategies in pregnancy.

详细描述

This observational cohort study was retrospectively registered at Clinical Trials.gov.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Pregnant women aged 18-40 years
  • Singleton pregnancy
  • Gestational age between 15 and 20 weeks confirmed by first-trimester ultrasound
  • Availability of stored maternal serum samples
  • Written informed consent

排除标准

  • Chronic hypertention
  • Pregestational diabetes mellitus
  • Renal disease
  • Multiple pregnancy
  • Smoking or alcohol use
  • Fetal structural or chromosomal anomalies
  • İmmunsuppressive treatment

研究组 & 干预措施

Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy

Control Group: Pregnant women with uncomplicated pregnancies matched for gestational age and demographic characteristics.

干预措施: Maternal serum cadherin-6 measurement (Other)

结局指标

主要结局

Development of preeclampsia, Diagnosis of preeclampsia defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation accompanied by proteinuria or signs of end-organ dysfunction.

时间窗: During pregnancy until delivery

次要结局

  • Concentration of maternal serum CDH-6(within one week of being diagnosed with preeclampsia)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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