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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03500588
Other study ID # BeniSuef 15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date February 2018

Study information

Verified date March 2021
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index of the umbilical artery.


Description:

Preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after 20 weeks of gestation. The pathophysiology of preeclampsia involves abnormalities in the development of placental vasculature early in pregnancy may result in relative placental under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal circulation that alter maternal endothelial function and cause hypertension and other manifestations of disease .Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. Human VEGF gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a family of proteins. There are several common single nucleotide polymorphisms (SNPs) in the VEGF gene, which could alter gene expression and protein production, and alter the risk of developing diseases characterized by deranged angiogenesis including preeclampsia.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date February 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: More than 20 weeks gestation. Preeclamptic patients Exclusion Criteria: association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension. association with auto-immune disease.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
PCR
Polymerase chain reaction was used to diagnose gene polymorphism.
Device:
Doppler ultrasound
Doppler ultrasound was used to assess the pulsatility index of the umbilical artery .

Locations

Country Name City State
Egypt Beni-Suef University Cairo Beni-Suef

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Chedraui P, Solis EJ, Bocci G, Gopal S, Russo E, Escobar GS, Hidalgo L, Pérez-López FR, Genazzani AR, Mannella P, Simoncini T. Feto-placental nitric oxide, asymmetric dimethylarginine and vascular endothelial growth factor (VEGF) levels and VEGF gene polymorphisms in severe preeclampsia. J Matern Fetal Neonatal Med. 2013 Feb;26(3):226-32. doi: 10.3109/14767058.2012.733760. Epub 2012 Oct 18. — View Citation

Cooper ME, Vranes D, Youssef S, Stacker SA, Cox AJ, Rizkalla B, Casley DJ, Bach LA, Kelly DJ, Gilbert RE. Increased renal expression of vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in experimental diabetes. Diabetes. 1999 Nov;48(11):2229-39. — View Citation

Huppertz B. Placental origins of preeclampsia: challenging the current hypothesis. Hypertension. 2008 Apr;51(4):970-5. doi: 10.1161/HYPERTENSIONAHA.107.107607. Epub 2008 Feb 7. Review. — View Citation

Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA. 2002 Jun 26;287(24):3183-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of VEGF gene mutation and preeclampsia Is VEGF gene polymorphism associated with preeclampsia from 20 weeks until delivery
Secondary fetal and neonatal outcomes Intrauterine growth restriction from 20 weeks until first postpartum week.
Secondary maternal outcome Maternal admission to intensive care unit from 20 weeks until delivery
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