<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02245477</url>
  </required_header>
  <id_info>
    <org_study_id>Beni-Suef 5</org_study_id>
    <nct_id>NCT02245477</nct_id>
  </id_info>
  <brief_title>Maternal Serum Vascular Endothelial Growth Factor in Pregnant Women With Foetal Growth Restriction</brief_title>
  <acronym>VEGF in FGR</acronym>
  <official_title>Evaluation of Maternal Serum VEGF in Pregnant Women With Foetal Growth Restriction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we explore To explore the role of maternal serum vascular endothelial growth&#xD;
      factor (VEGF) in pregnancies complicated by foetal growth restriction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small-for-gestational age (SGA) is defined as an estimated foetal weight (EFW) or abdominal&#xD;
      circumference (AC) less than the 10th centileand severe SGA as an EFW or AC less than the 3rd&#xD;
      centile. Foetal Growth Restriction refers to failure of the foetus to achieve its&#xD;
      predetermined growth potential for various reasons.Foetus with foetal growth restriction&#xD;
      (FGR) greatly contributes to perinatal mortality and short- and long-term morbidity. There is&#xD;
      a 3-10 fold increase in perinatal mortality in pregnancies complicated by this FGR .The&#xD;
      incidence of FGR in newborns ranges between 3 and 7% of the total population .FGR is thought&#xD;
      to stem from placental hypoxia-induced vasoconstriction of the fetoplacental vessels, leading&#xD;
      to placental hypoperfusion and thus fetal undernutrition. However, the effects of hypoxia on&#xD;
      the fetoplacental vessels have been surprisingly little studied.Vascular endothelial growth&#xD;
      factor (VEGF) is one of the factors that take part in placental angiogenesis. It is highly&#xD;
      expressed during embryonic and foetal development..Angiogenesis involves the branching of new&#xD;
      microvessles from pre-existing larger blood vessels.Angiogenesis plays a role in the&#xD;
      development of the villous vasculature and the formation of terminal villi in human placenta.&#xD;
      IUGR occurs as a result of the failure of elongation, branching and dilatation of the&#xD;
      capillary loops and of terminal villous formation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Obstetric ultrasound</measure>
    <time_frame>from 28 weeks gestation to 36 weeks gestation</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Vascular Endothelial growth factor</measure>
    <time_frame>3 months until delivery</time_frame>
    <description>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 &amp; D Systems, Inc , (Minneapolis, MN, USA).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Foetal Growth Restriction</condition>
  <arm_group>
    <arm_group_label>Obstetric Ultrasoud</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum Vascular Endothelial Growth Factor</arm_group_label>
    <description>Serum VEGF concentration will be determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R &amp; D Systems, Inc , (Minneapolis, MN, USA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>obstetric Ultrasound</intervention_name>
    <description>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.</description>
    <arm_group_label>Obstetric Ultrasoud</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>serum Vascular Endothelial Growth Factor</intervention_name>
    <description>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</description>
    <arm_group_label>Serum Vascular Endothelial Growth Factor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with gestational age 28-36 weeks were included in our study. Patients with SGA&#xD;
        were defined by obstetric ultrasound as estimated fetal weight was below&#xD;
        the10thcentile.Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with&#xD;
        abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks&#xD;
        later and FGR will be diagnosed if fetal weight had faltered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-40 years&#xD;
&#xD;
          -  Gestational age 28-36 weeks&#xD;
&#xD;
          -  Fetal growth restriction&#xD;
&#xD;
          -  Patient consents to the procedure.&#xD;
&#xD;
          -  BMI 20-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Fetal congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nesreen A Shehata, MD</last_name>
    <phone>00201227866337</phone>
    <email>nesoomar@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nesreen Abdel Fattah Abdullah Shehata</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nesreen A Shehata, MD</last_name>
      <phone>00201024150605</phone>
      <email>nesoomar@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Nesreen A Shehata, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>January 30, 2021</last_update_submitted>
  <last_update_submitted_qc>January 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Nesreen Abdel Fattah Abdullah Shehata</investigator_full_name>
    <investigator_title>Lecturer of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Serum VEGF, FGR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
    <mesh_term>Endothelial Growth Factors</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02245477
org study id: Beni-Suef 5
nct id: NCT02245477
lead sponsor: 
has dmc: Yes
In this study we explore To explore the role of maternal serum vascular endothelial growth
      factor (VEGF) in pregnancies complicated by foetal growth restriction.
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.
observational model: Case-Control
time perspective: Prospective
measure: Obstetric ultrasound
time frame: from 28 weeks gestation to 36 weeks gestation
description: 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.
measure: Serum Vascular Endothelial growth factor
time frame: 3 months until delivery
description: 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).
arm group label: Obstetric Ultrasoud
description: 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.
arm group label: Serum Vascular Endothelial Growth Factor
description: 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).
intervention type: Device
intervention name: obstetric Ultrasound
description: 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.
arm group label: Obstetric Ultrasoud
intervention type: Other
intervention name: serum Vascular Endothelial Growth Factor
description: 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
arm group label: Serum Vascular Endothelial Growth Factor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Nesreen A Shehata, MD
phone: 00201227866337
email: nesoomar@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Nesreen Abdel Fattah Abdullah Shehata
investigator title: Lecturer of Obstetrics and Gynecology
mesh term: Fetal Growth Retardation
mesh term: Mitogens
mesh term: Endothelial Growth Factors