Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

• ClinicalTrials.gov Identifier: NCT03821922
• Recruitment Status: Unknown
• First Posted: January 30, 2019
• Last Update Posted: January 30, 2019
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Information provided by (Responsible Party): Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University

Study Description

Brief 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.

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Expression of Endocrine Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy
• Estimated Study Start Date: May 1, 2019
• Estimated Primary Completion Date: December 30, 2019
• Estimated Study Completion Date: December 31, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Expression of FGF23 [ Time Frame: up to 14 weeks ]
   expression of FGF23 in different groups in mmol/l
2. Expression of FGF23 [ Time Frame: up to 28 weeks ]
   expression of FGF23 in different groups in mmol/l
3. Expression of FGF23 [ Time Frame: up to 40 weeks ]
   expression of FGF23 in different groups in mmol/l

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

university hospital

Criteria

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.

Contacts and Locations

Contacts

Contact: Dongyu Wang, M.D,PhD; 86-020-87755766; dongyugd@aliyun.com

Locations

China, Guangdong

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Sponsors and Collaborators

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

More Information

• Responsible Party: Dongyu Wang, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT03821922
• Other Study ID Numbers: FGF23
• First Posted: January 30, 2019
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University:

Hypertension, Pregnancy-Induced; FGF23

Additional relevant MeSH terms:

Hypertension, Pregnancy-Induced; Pregnancy Complications; Hypertension; Vascular Diseases; Cardiovascular Diseases