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RecruitingNCT03821922Updated Jul 24, 2023

Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

An observational study in Hypertension, Pregnancy-Induced, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2017; still recruiting 8 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension, Pregnancy-Induced

Keywords

  • Hypertension, Pregnancy-Induced
  • FGF23
03

In context

Pregnancy Complications

437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.

This study's planned enrollment of 300 is close to the median of 320 across 205 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

university hospital

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • pregnancy-induced pregnancy

    Those women (subjects) with pregnancy-induced pregnancy.

  • Control

    Those healthy pregnant women

06

What researchers measure

Primary outcomes

  1. Expression of FGF23

    expression of FGF23 in different groups in mmol/l

    Time frame: up to 14 weeks

  2. Expression of FGF23

    expression of FGF23 in different groups in mmol/l

    Time frame: up to 28 weeks

  3. Expression of FGF23

    expression of FGF23 in different groups in mmol/l

    Time frame: up to 40 weeks

07

Study locations

1 of 1 sites recruiting
  • Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    • Dongyu Wang, M.D., PhD · Contact · dongyugd@aliyun.com · 86-020-87755766
    • Dongyu Wang, M.D.,PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03821922
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Dongyu Wang (Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Jan 30, 2019
Start date
Dec 1, 2017
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jul 24, 2023

Study contacts

Dongyu Wang, M.D,PhD
Contact
dongyugd@aliyun.com
86-020-87755766
Zilian Wang, M.D,PhD
study director · O&G Department of the 1st affiliated hospital of Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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