Clinical trial NCT03500588: Vascular Endothelial Factor Gene Polymorphism in Preeclampsia
Official title: Vascular Endothelial Growth Factor C/A 2578 Gene Polymorphism and Umbilical Artery Doppler in Preeclamptic Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: normal and preeclamptic pregnant women after 20 weeks were evaluated for VEGF gene polymorphism.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of VEGF gene mutation and preeclampsia
timeFrame: from 20 weeks until delivery
Secondary outcomes:
measure: fetal and neonatal outcomes
timeFrame: from 20 weeks until first postpartum week.
measure: maternal outcome
timeFrame: from 20 weeks until delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
state: Beni-Suef
Study officials:
References:
citation: Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA. 2002 Jun 26;287(24):3183-6. doi: 10.1001/jama.287.24.3183. No abstract available.
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. No abstract available.
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. doi: 10.2337/diabetes.48.11.2229.
citation: Chedraui P, Solis EJ, Bocci G, Gopal S, Russo E, Escobar GS, Hidalgo L, Perez-Lopez 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.