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临床试验/NCT03821922
NCT03821922招募中不适用

Expression of Endocrine Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Expression of FGF23

研究概览

简要总结

Hypertensive disorder complicating pregnancy is a set of diseases of pregnancy coexisting with elevated blood pressure. The incidence of it is approximately 5-12%. Pregnancy-induced hypertension is a pregnancy-specific disorder, severely impairing both maternal and fetal health, and the major cause of maternal and perinatal mortality rate increased. But so far, the specific etiology is still unclear.

Recently, fibroblast growth factor 23 (FGF23) has emerged as key endocrine regulators of the metabolism of vitamin D and calcium and phosphorus by combining FGFR-α- Klotho receptor complex. Current studies showed that α- Klotho involved the development of gestational hypertension via the production of endothelial nitric oxide, angiogenesis, and the formation of antioxidant enzymes. On the other hand, vitamin D deficiency during pregnancy has an adverse impact on maternal and fetal health, including gestational hypertension. Therefore, the relationship of the expression of FGF23 and the development of gestational hypertension has attracted the attention of relevant scholars.

The aim of this study is to detect the difference of the expression of FGF23 between the hypertensive women and normal pregnant women.

详细描述

100 pregnant women with hypertensive disorder complicating pregnancy and 200 normal pregnant control women matched for maternal and gestational age were enrolled in the study. All the subjects underwent antepartum screening in the First Affiliated Hospital of Sun Yat-sen University. Blood samples were obtained after overnight fasting at the first, second and third trimester respectively. Serum FGF23 levels were determined by enzyme-linked immunosorbent assay (ELISA) and were correlated with anthropometric, metabolic, and endocrine parameters.

Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard deviations or median with interquartile range. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. Correlation analysis was performed using the Spearman rank correlation method. To identify independent relationships and adjust the effects of covariates, multiple linear regression analyses were performed. P values of <0.05 were considered significant.

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

  • Women with singleton pregnancy;
  • Regular antenatal examination from the first trimester;
  • Give birth in the university hospital (The 1st affiliated hospital of Sun Yat-sen University)

排除标准

  • Younger than 18 years old;
  • Older than 40 years old;
  • Multiple pregnancy;
  • Complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.

结局指标

主要结局

Expression of FGF23

时间窗: up to 40 weeks

expression of FGF23 in different groups in mmol/l

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dongyu Wang

Principal Investigator

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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