<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/NCT01680484</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 10/117-13</org_study_id>
    <nct_id>NCT01680484</nct_id>
  </id_info>
  <brief_title>Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns</brief_title>
  <official_title>Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Sami Ulus Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Sami Ulus Children's Hospital</source>
  <brief_summary>
    <textblock>
      There are multiple factors affecting the variability and acceleration pattern of fetal heart&#xD;
      rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor&#xD;
      decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be&#xD;
      stimulated by manual manipulation, sound, light, change in maternal position and maternal&#xD;
      ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently&#xD;
      practiced in outpatient settings. This is not only medical but also a social routine. In this&#xD;
      study the investigators have chosen the two most popular so-called 'fetal accelerators',&#xD;
      chocolate and orange juice against no intervention and tried to find any usefulness of these&#xD;
      on non-reactive NST patterns.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in reactivity of NST</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase in the maternal fetal movement perception</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Nonreassuring Fetal Status</condition>
  <arm_group>
    <arm_group_label>Bitter chocolate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ülker İçim Orange Juice 250 cc, İstanbul, Turkey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sit and rest</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bitter chocolate</intervention_name>
    <arm_group_label>Bitter chocolate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Orange juice</intervention_name>
    <arm_group_label>Orange juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive&#xD;
             NST pattern without decelerations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancies, fetal anomaly, hypertension, intrauterine growth restriction,&#xD;
             active labor, contractions or decelerations on NST, absence of a first or second&#xD;
             trimester ultrasonography for accurate gestational dating, pre-gestational or&#xD;
             gestational diabetes and known allergy to chocolate or orange&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sertac Esin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr. Sami Ulus Maternity and Children's Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Sami Ulus Maternity and Children's Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Sami Ulus Children's Hospital</investigator_affiliation>
    <investigator_full_name>Sertac ESIN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>non-stress test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Distress</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/NCT01680484
org study id: HEK 10/117-13
nct id: NCT01680484
lead sponsor: 
There are multiple factors affecting the variability and acceleration pattern of fetal heart
      rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor
      decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be
      stimulated by manual manipulation, sound, light, change in maternal position and maternal
      ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently
      practiced in outpatient settings. This is not only medical but also a social routine. In this
      study the investigators have chosen the two most popular so-called 'fetal accelerators',
      chocolate and orange juice against no intervention and tried to find any usefulness of these
      on non-reactive NST patterns.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Increase in reactivity of NST
time frame: 30 minutes
measure: Increase in the maternal fetal movement perception
time frame: 30 minutes
arm group label: Bitter chocolate
arm group type: Active Comparator
description: 50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey
arm group label: Orange juice
arm group type: Active Comparator
description: Ülker İçim Orange Juice 250 cc, İstanbul, Turkey
arm group label: Control
arm group type: No Intervention
description: Sit and rest
intervention type: Dietary Supplement
intervention name: Bitter chocolate
arm group label: Bitter chocolate
intervention type: Dietary Supplement
intervention name: Orange juice
arm group label: Orange juice
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Sertac Esin, MD
role: Principal Investigator
affiliation: Dr. Sami Ulus Maternity and Children's Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dr. Sami Ulus Children's Hospital
investigator full name: Sertac ESIN
investigator title: Principal Investigator
mesh term: Fetal Distress