NCT03821922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

6.1 years

First QC Date

January 23, 2019

Last Update Submit

July 21, 2023

Conditions

Keywords

Hypertension, Pregnancy-InducedFGF23

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

pregnancy-induced pregnancy

Those women (subjects) with pregnancy-induced pregnancy.

Control

Those healthy pregnant women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

university hospital

You may qualify if:

  • 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)

You may not qualify if:

  • Younger than 18 years old;
  • Older than 40 years old;
  • Multiple pregnancy;
  • Complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Zilian Wang, M.D,PhD

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

    STUDY DIRECTOR

Central Study Contacts

Dongyu Wang, M.D,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 30, 2019

Study Start

December 1, 2017

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations