Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy
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|ClinicalTrials.gov Identifier: NCT03821922|
Recruitment Status : Unknown
Verified January 2019 by Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
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|
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|
|Estimated Enrollment :||300 participants|
|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|
Those women (subjects) with pregnancy-induced pregnancy.
Those healthy pregnant women
- Expression of FGF23 [ Time Frame: up to 14 weeks ]expression of FGF23 in different groups in mmol/l
- Expression of FGF23 [ Time Frame: up to 28 weeks ]expression of FGF23 in different groups in mmol/l
- Expression of FGF23 [ Time Frame: up to 40 weeks ]expression of FGF23 in different groups in mmol/l
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821922
|Contact: Dongyu Wang, M.D,PhDfirstname.lastname@example.org|
|Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Study Director:||Zilian Wang, M.D,PhD||O&G Department of the 1st affiliated hospital of Sun Yat-sen University|