Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821922
• Other study ID #: FGF23
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Complications

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