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

NCT ID: NCT02245477

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Foetal Growth Restriction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

obstetric Ultrasound

Intervention Type DEVICE

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).

serum Vascular Endothelial Growth Factor

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Nesreen Abdel Fattah Abdullah Shehata

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nesreen Abdel Fattah Abdullah Shehata

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nesreen A Shehata, MD

Role: CONTACT

00201227866337

Facility Contacts

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Nesreen A Shehata, MD

Role: primary

00201024150605

Other Identifiers

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Beni-Suef 5

Identifier Type: -

Identifier Source: org_study_id

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