Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

NCT ID: NCT03821922

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension, Pregnancy-Induced

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnancy-induced pregnancy

Those women (subjects) with pregnancy-induced pregnancy.

No interventions assigned to this group

Control

Those healthy pregnant women

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Dongyu Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zilian Wang, M.D,PhD

Role: STUDY_DIRECTOR

O&G Department of the 1st affiliated hospital of Sun Yat-sen University

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongyu Wang, M.D,PhD

Role: CONTACT

86-020-87755766

Facility Contacts

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Dongyu Wang, M.D., PhD

Role: primary

86-020-87755766

Other Identifiers

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FGF23

Identifier Type: -

Identifier Source: org_study_id

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