<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/NCT03232294</url>
  </required_header>
  <id_info>
    <org_study_id>2017/222</org_study_id>
    <nct_id>NCT03232294</nct_id>
  </id_info>
  <brief_title>Fetal Front-abdominal Wall Thickness and Perinatal Outcome</brief_title>
  <official_title>Effect of Fetal Front-abdominal Wall Thickness on Birth Weight and Perinatal Outcome at 24-26. Gestational Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kayseri Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abnormal fetal development such as macrosomia can cause some complications on both fetus and&#xD;
      mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy&#xD;
      examination that it can be obtained during an examination of a pregnant woman by ultrasound.&#xD;
      Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and&#xD;
      increase childbirth complications and operative birth. There are some studies scrutinizing&#xD;
      the relationship between FAWT and diabetes in the literature. However there are few studies&#xD;
      which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal&#xD;
      outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators&#xD;
      wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome&#xD;
      regarding with macrosomia in the second trimester.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>The relationship between fetal abdominal wall thickness and macrosomia</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>Fetal Macrosomia</condition>
  <condition>Abdominal Wall Mass</condition>
  <condition>Perinatal Problems</condition>
  <arm_group>
    <arm_group_label>the study group</arm_group_label>
    <description>A total of 96 women with low risk pregnancy coming to the clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal&#xD;
        examination in 26-28th gestational weeks were included to this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal&#xD;
        examination in 26-28th gestational weeks were included to this study and performed 75 gr-&#xD;
        oral glucose tolerance test (OGTT).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The participants with a positive 75-g OGTT were excluded. Additionally those following&#xD;
        criteria were accepted as the exclusion criteria of this study: hypertension, preeclampsia,&#xD;
        diabetes, fetal distress, fetal anomaly, multiple pregnancy, preterm labor, preterm&#xD;
        premature rupture of membrane, placenta previa, polyhydramnios and intrauterine fetal&#xD;
        growth restriction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YUSUF MADENDAG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Yusuf MADENDAG</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>fetal macrosomia</keyword>
  <keyword>fetal abdominal wall thickness</keyword>
  <keyword>subcutaneous adipose tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Macrosomia</mesh_term>
  </condition_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/NCT03232294
org study id: 2017/222
nct id: NCT03232294
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Abnormal fetal development such as macrosomia can cause some complications on both fetus and
      mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy
      examination that it can be obtained during an examination of a pregnant woman by ultrasound.
      Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and
      increase childbirth complications and operative birth. There are some studies scrutinizing
      the relationship between FAWT and diabetes in the literature. However there are few studies
      which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal
      outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators
      wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome
      regarding with macrosomia in the second trimester.
observational model: Cohort
time perspective: Prospective
measure: The relationship between fetal abdominal wall thickness and macrosomia
time frame: 6 months
arm group label: the study group
description: A total of 96 women with low risk pregnancy coming to the clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: YUSUF MADENDAG
role: Principal Investigator
affiliation: Kayseri Education and Research Hospital
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Yusuf MADENDAG
investigator title: principal investigator
mesh term: Fetal Macrosomia