<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/NCT03755024</url>
  </required_header>
  <id_info>
    <org_study_id>WHOFC</org_study_id>
    <nct_id>NCT03755024</nct_id>
  </id_info>
  <brief_title>WHO Fetal Growth Charts</brief_title>
  <official_title>Implementation of WHO Fetal Growth Charts in Assiut,Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perinatal mortality and morbidity continue to be major global health challenges strongly&#xD;
      associated with prematurity and reduced fetal growth, an issue of further interest given the&#xD;
      mounting evidence that fetal growth in general is linked to degrees of risk of common&#xD;
      noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is&#xD;
      today very widely used in clinical practice, and, while essential for the identification and&#xD;
      management of high-risk pregnancies,the current reference ranges used worldwide are largely&#xD;
      based on single populations from a few high-income countries and are therefore of uncertain&#xD;
      general applicability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Against this background, WHO made it a high priority to provide fetal growth charts for&#xD;
      estimated fetal weight and common ultrasound biometric measurements intended for worldwide&#xD;
      use. WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that&#xD;
      fetal growth differs significantly between countries. Growth was to a small extent influenced&#xD;
      by maternal age, height, weight, and parity, and by fetal sex. The study suggested that these&#xD;
      WHO charts for growth are more suitable for international use than those commonly applied&#xD;
      today. However, the differences between countries, with maternal factors, and with fetal sex&#xD;
      mean that these growth charts may need to be adjusted for local clinical use to increase&#xD;
      their diagnostic and predictive performance. In our setting, we are using the charts built in&#xD;
      the ultrasound machines based on studies done in western countries. So, it is prudent now to&#xD;
      implement the WHO fetal growth charts in our setting&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts</measure>
    <time_frame>8 months</time_frame>
    <description>correlation of fetal growth pattern with neonatal birth weight and outcome</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Fetal Growth Complications</condition>
  <arm_group>
    <arm_group_label>normal group</arm_group_label>
    <description>fetuses with normal growth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Growth retardation group</arm_group_label>
    <description>fetuses with retarded growth</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:&#xD;
Biparietal diameter&#xD;
Head circumference&#xD;
Abdominal circumference&#xD;
Femur length&#xD;
Humerus length</description>
    <arm_group_label>Growth retardation group</arm_group_label>
    <arm_group_label>normal group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of&#xD;
        Medicine, Assiut university.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  They have body-mass index between 18-30;&#xD;
&#xD;
          -  They have a singleton pregnancy;&#xD;
&#xD;
          -  Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual&#xD;
             period.&#xD;
&#xD;
          -  They have no history of health, environmental or economic constraints likely to impede&#xD;
             fetal growth; need for long-term medication (including fertility treatment); smoking&#xD;
             currently or in the previous 6 months; recurrent miscarriage; and any previous baby&#xD;
             delivered pre-term (&lt;37 weeks) or with a birth weight &lt;2,500g b. Exclusion criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mina eshak tawfeek khalil</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03755024
org study id: WHOFC
nct id: NCT03755024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perinatal mortality and morbidity continue to be major global health challenges strongly
      associated with prematurity and reduced fetal growth, an issue of further interest given the
      mounting evidence that fetal growth in general is linked to degrees of risk of common
      noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is
      today very widely used in clinical practice, and, while essential for the identification and
      management of high-risk pregnancies,the current reference ranges used worldwide are largely
      based on single populations from a few high-income countries and are therefore of uncertain
      general applicability.
Against this background, WHO made it a high priority to provide fetal growth charts for
      estimated fetal weight and common ultrasound biometric measurements intended for worldwide
      use. WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that
      fetal growth differs significantly between countries. Growth was to a small extent influenced
      by maternal age, height, weight, and parity, and by fetal sex. The study suggested that these
      WHO charts for growth are more suitable for international use than those commonly applied
      today. However, the differences between countries, with maternal factors, and with fetal sex
      mean that these growth charts may need to be adjusted for local clinical use to increase
      their diagnostic and predictive performance. In our setting, we are using the charts built in
      the ultrasound machines based on studies done in western countries. So, it is prudent now to
      implement the WHO fetal growth charts in our setting
observational model: Cohort
time perspective: Prospective
measure: Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts
time frame: 8 months
description: correlation of fetal growth pattern with neonatal birth weight and outcome
arm group label: normal group
description: fetuses with normal growth
arm group label: Growth retardation group
description: fetuses with retarded growth
intervention type: Device
intervention name: ultrasound
description: The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:
Biparietal diameter
Head circumference
Abdominal circumference
Femur length
Humerus length
arm group label: Growth retardation group
arm group label: normal group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mina eshak tawfeek khalil
investigator title: Principal investigator