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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821922
Other study ID # FGF23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Dongyu Wang, M.D,PhD
Phone 86-020-87755766
Email dongyugd@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - Younger than 18 years old; - Older than 40 years old; - Multiple pregnancy; - Complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.

Study Design


Locations

Country Name City State
China Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expression of FGF23 expression of FGF23 in different groups in mmol/l up to 14 weeks
Primary Expression of FGF23 expression of FGF23 in different groups in mmol/l up to 28 weeks
Primary Expression of FGF23 expression of FGF23 in different groups in mmol/l up to 40 weeks
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