<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/NCT04497532</url>
  </required_header>
  <id_info>
    <org_study_id>0152-19-WOMC</org_study_id>
    <nct_id>NCT04497532</nct_id>
  </id_info>
  <brief_title>Influence of Diet on Pregnancy With Polyhydramnios</brief_title>
  <official_title>The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</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>
      To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic&#xD;
      fluid index in women with idiopathic polyhydramnios.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 20, 2021</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amniotic fluid index (AFI) after 2 weeks</measure>
    <time_frame>Assess AFI two weeks after diet initiation</time_frame>
    <description>AFI as measured in ultrasound</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Polyhydramnios</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet as suited for gestational diabetes mellitus</intervention_name>
    <description>Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.</description>
    <arm_group_label>Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI&#xD;
             at 95% or more by gestational age&#xD;
&#xD;
          -  Express their consent to participate in the study and try to make the recommended&#xD;
             dietary change for at least two consecutive weeks from the moment the guidelines are&#xD;
             given.&#xD;
&#xD;
          -  Without a medical indication for an immediate delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical recommendation for delivery within two weeks of diagnosis&#xD;
&#xD;
          -  Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes,&#xD;
             fetal malformation, proof of fetal infection&#xD;
&#xD;
          -  Premature rupture or membranes&#xD;
&#xD;
          -  Twins pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liliya Tamayev, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liliya Tamayev, MD</last_name>
    <phone>+972532343882</phone>
    <email>t_liki@yahoo.com</email>
  </overall_contact>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Liliya Tamayev</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04497532
org study id: 0152-19-WOMC
nct id: NCT04497532
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic
      fluid index in women with idiopathic polyhydramnios.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Amniotic fluid index (AFI) after 2 weeks
time frame: Assess AFI two weeks after diet initiation
description: AFI as measured in ultrasound
arm group label: Control
arm group type: No Intervention
arm group label: Diet
arm group type: Experimental
intervention type: Other
intervention name: Diet as suited for gestational diabetes mellitus
description: Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.
arm group label: Diet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liliya Tamayev, MD
role: Principal Investigator
affiliation: Wolfson Medical Center
last name: Liliya Tamayev, MD
phone: +972532343882
email: t_liki@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Liliya Tamayev
investigator title: Principal Investigator
mesh term: Polyhydramnios
sharing ipd: No