Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension, Pregnancy-Induced

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dongyu Wang, M.D,PhD; Phone Number: 86-020-87755766; Email: dongyugd@aliyun.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
      • Contact: Dongyu Wang, M.D., PhD; Phone Number: 86-020-87755766; Email: dongyugd@aliyun.com
      • Principal Investigator: Dongyu Wang, M.D.,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

university hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
pregnancy-induced pregnancy; Those women (subjects) with pregnancy-induced pregnancy.
Control; Those healthy pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of FGF23	expression of FGF23 in different groups in mmol/l	up to 14 weeks
Expression of FGF23	expression of FGF23 in different groups in mmol/l	up to 28 weeks
Expression of FGF23	expression of FGF23 in different groups in mmol/l	up to 40 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Zilian Wang, M.D,PhD, O&G Department of the 1st affiliated hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: FGF23; Hypertension, Pregnancy-Induced
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Pregnancy Complications; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: FGF23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No