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

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02245477
Collaborator
(none)
100
1
81
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Maternal Serum VEGF in Pregnant Women With Foetal Growth Restriction
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Obstetric ultrasound [from 28 weeks gestation to 36 weeks gestation]

    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.

Secondary Outcome Measures

  1. Serum Vascular Endothelial growth factor [3 months until delivery]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nesreen Abdel Fattah Abdullah Shehata Cairo Egypt

Sponsors and Collaborators

  • Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nesreen Abdel Fattah Abdullah Shehata, Lecturer of Obstetrics and Gynecology, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT02245477
Other Study ID Numbers:
  • Beni-Suef 5
First Posted:
Sep 19, 2014
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Lecturer of Obstetrics and Gynecology, Beni-Suef University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2021