Vascular Endothelial Factor Gene Polymorphism in Preeclampsia

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03500588
• Collaborator: (none)
• Enrollment: 290
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 22.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Diagnostic Test: PCR; Device: Doppler ultrasound

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 290 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Vascular Endothelial Growth Factor C/A 2578 Gene Polymorphism and Umbilical Artery Doppler in Preeclamptic Women
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
normotensive pregnant women more than 20 weeks gestation. One hundred and forty-five pregnant women after 20 weeks with normal blood pressure were evaluated for VEGF gene mutation.	Diagnostic Test: PCR; Polymerase chain reaction was used to diagnose gene polymorphism.
Pregnant women after 20 weeks with preeclampsia. One hundred and forty-five pregnant women after 20 weeks with preeclampsia were evaluated for VEGF gene mutation by using PCR and Pulsitality index of umbilical artery by doppler velocimetry.	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 .

Outcome Measures

Primary Outcome Measures

1. Correlation of VEGF gene mutation and preeclampsia [from 20 weeks until delivery]

   Is VEGF gene polymorphism associated with preeclampsia

Secondary Outcome Measures

1. fetal and neonatal outcomes [from 20 weeks until first postpartum week.]

   Intrauterine growth restriction

2. maternal outcome [from 20 weeks until delivery]

   Maternal admission to intensive care unit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni-Suef University	Cairo	Beni-Suef	Egypt	12412

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Assistant professor, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT03500588
• Other Study ID Numbers: BeniSuef 15
• First Posted: Apr 18, 2018
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pre-Eclampsia

Study Results

No Results Posted as of Mar 26, 2021