<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/NCT03277417</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0037-17</org_study_id>
    <nct_id>NCT03277417</nct_id>
  </id_info>
  <brief_title>Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?</brief_title>
  <official_title>Does the Amniotic Fluid Index Affect the Fetal Cardiac Performance?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery&#xD;
      outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and&#xD;
      polyhydramnios.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Fetal cardiac ventricles</measure>
    <time_frame>One month</time_frame>
    <description>The width of the fetal cardiac ventricles will be measured and compared between all three groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational age</measure>
    <time_frame>One month</time_frame>
    <description>Gestational age at delivery will be compared between the three groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>One month</time_frame>
    <description>Mode of delivery will be compared between the three groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>One month</time_frame>
    <description>Birth weight will be compared between the three groups</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Oligohydramnios</condition>
  <condition>Polyhydramnios</condition>
  <arm_group>
    <arm_group_label>Isolated Oligohydramnios</arm_group_label>
    <description>Fetuses with amniotic fluid index (AFI) equal or less than 5 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isolated Polyhydramnios</arm_group_label>
    <description>Fetuses with amniotic fluid index (AFI) more than 25 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Fetuses with normal amount of amniotic fluid</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Imaging of fetal heart and amniotic fluid</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Isolated Oligohydramnios</arm_group_label>
    <arm_group_label>Isolated Polyhydramnios</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women attending the Hillel Yaffe Medical Center's OB/GYN clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 24-42 weeks&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fetal anatomical or chromosomal abnormality&#xD;
&#xD;
          -  Known fetal cardiac defect&#xD;
&#xD;
          -  Suspected fetal infection&#xD;
&#xD;
          -  Suspected IUGR&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Rinat Gabbay-Benziv, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rinat Gabbay-Benziv, MD</last_name>
    <phone>972-4-6304512</phone>
    <email>rinatg@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>H̱adera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Rinat Gabbay-Benziv, MD</last_name>
      <email>rinatg@hy.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oligohydramnios</mesh_term>
    <mesh_term>Polyhydramnios</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277417
org study id: HYMC-0037-17
nct id: NCT03277417
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery
      outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and
      polyhydramnios.
observational model: Case-Control
time perspective: Prospective
measure: Fetal cardiac ventricles
time frame: One month
description: The width of the fetal cardiac ventricles will be measured and compared between all three groups
measure: Gestational age
time frame: One month
description: Gestational age at delivery will be compared between the three groups
measure: Mode of delivery
time frame: One month
description: Mode of delivery will be compared between the three groups
measure: Birth weight
time frame: One month
description: Birth weight will be compared between the three groups
arm group label: Isolated Oligohydramnios
description: Fetuses with amniotic fluid index (AFI) equal or less than 5 cm
arm group label: Isolated Polyhydramnios
description: Fetuses with amniotic fluid index (AFI) more than 25 cm
arm group label: Control Group
description: Fetuses with normal amount of amniotic fluid
intervention type: Other
intervention name: Echocardiography
description: Imaging of fetal heart and amniotic fluid
arm group label: Control Group
arm group label: Isolated Oligohydramnios
arm group label: Isolated Polyhydramnios
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
last name: Rinat Gabbay-Benziv, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Rinat Gabbay-Benziv, MD
phone: 972-4-6304512
email: rinatg@hy.health.gov.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Oligohydramnios
mesh term: Polyhydramnios
sharing ipd: No