Maternal Serum Vascular Endothelial Growth Factor in Pregnant Women With Foetal Growth Restriction (VEGF in FGR)

Evaluation of Maternal Serum VEGF in Pregnant Women With Foetal Growth Restriction

In this study we explore To explore the role of maternal serum vascular endothelial growth factor (VEGF) in pregnancies complicated by foetal growth restriction.

Study Overview

• Status: Unknown
• Conditions: Foetal Growth Restriction
• Intervention / Treatment: Device: obstetric Ultrasound; Other: serum Vascular Endothelial Growth Factor

Detailed Description

Small-for-gestational age (SGA) is defined as an estimated foetal weight (EFW) or abdominal circumference (AC) less than the 10th centileand severe SGA as an EFW or AC less than the 3rd centile. Foetal Growth Restriction refers to failure of the foetus to achieve its predetermined growth potential for various reasons.Foetus with foetal growth restriction (FGR) greatly contributes to perinatal mortality and short- and long-term morbidity. There is a 3-10 fold increase in perinatal mortality in pregnancies complicated by this FGR .The incidence of FGR in newborns ranges between 3 and 7% of the total population .FGR is thought to stem from placental hypoxia-induced vasoconstriction of the fetoplacental vessels, leading to placental hypoperfusion and thus fetal undernutrition. However, the effects of hypoxia on the fetoplacental vessels have been surprisingly little studied.Vascular endothelial growth factor (VEGF) is one of the factors that take part in placental angiogenesis. It is highly expressed during embryonic and foetal development..Angiogenesis involves the branching of new microvessles from pre-existing larger blood vessels.Angiogenesis plays a role in the development of the villous vasculature and the formation of terminal villi in human placenta. IUGR occurs as a result of the failure of elongation, branching and dilatation of the capillary loops and of terminal villous formation.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Nesreen Abdel Fattah Abdullah Shehata
    • Contact: Nesreen A Shehata, MD; Phone Number: 00201024150605; Email: nesoomar@yahoo.com
    • Principal Investigator: Nesreen A Shehata, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile.Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had faltered.

Description

Inclusion Criteria:

• Age 20-40 years
• Gestational age 28-36 weeks
• Fetal growth restriction
• Patient consents to the procedure.
• BMI 20-30

Exclusion Criteria:

• Preeclampsia
• Diabetes Mellitus
• Fetal congenital anomalies

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstetric Ultrasoud; Transabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta.	Device: obstetric Ultrasound; Transabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta.
Serum Vascular Endothelial Growth Factor; Serum VEGF concentration will be determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R & D Systems, Inc , (Minneapolis, MN, USA).	Other: serum Vascular Endothelial Growth Factor; Maternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric ultrasound	Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile. Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had altered.	from 28 weeks gestation to 36 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Vascular Endothelial growth factor	Maternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees.Serum VEGF concentration was determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R & D Systems, Inc , (Minneapolis, MN, USA).	3 months until delivery

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Serum VEGF, FGR
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Growth Substances; Endothelial Growth Factors; Mitogens
• Other Study ID Numbers: Beni-Suef 5