<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/NCT03798275</url>
  </required_header>
  <id_info>
    <org_study_id>2017/489</org_study_id>
    <nct_id>NCT03798275</nct_id>
  </id_info>
  <brief_title>Coffee Consumption and Pregnancy</brief_title>
  <official_title>The Effect of Coffee Consumption on Fetal Renal Artery Blood Flow and Amniotic Fluid Volume in the Third Trimester of Pregnancy</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>
      Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed&#xD;
      during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood&#xD;
      flow and amniotic fluid index (AFI) in the third trimester of pregnancy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional study occurred in a tertiary center with volunteer pregnant women who&#xD;
      agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios,&#xD;
      AFI and fetal renal artery blood flow indices were evaluated before and after coffee&#xD;
      consumption. Sixty three patients for the borderline oligohydramnios group (the study group)&#xD;
      were included in this study. These patients were compared with 63 healthy pregnant women who&#xD;
      had normal amniotic fluid volume (the control group)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amniotic fluid index</measure>
    <time_frame>two hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fetal renal artery doppler indices</measure>
    <time_frame>two hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Coffee</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>the study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>healthy pregnant women with normal amniotic volume</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>coffee</intervention_name>
    <description>2 g Nescafe Clasico contains approximately 65 mg caffeine</description>
    <arm_group_label>the study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th&#xD;
             weeks of gestation were included in this study during routine antenatal examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4&#xD;
             hours previous to ultrasonographic examination [10], abnormal Doppler blood flow,&#xD;
             hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction,&#xD;
             fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple&#xD;
             pregnancies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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 MADENDAĞ</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yusuf Madendağ</name>
      <address>
        <city>Kayseri̇</city>
        <zip>38090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</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>obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>amniotic fluid index</keyword>
  <keyword>caffeine</keyword>
  <keyword>coffee</keyword>
  <keyword>oligohydramnios</keyword>
  <!-- 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/NCT03798275
org study id: 2017/489
nct id: NCT03798275
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed
      during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood
      flow and amniotic fluid index (AFI) in the third trimester of pregnancy
This cross-sectional study occurred in a tertiary center with volunteer pregnant women who
      agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios,
      AFI and fetal renal artery blood flow indices were evaluated before and after coffee
      consumption. Sixty three patients for the borderline oligohydramnios group (the study group)
      were included in this study. These patients were compared with 63 healthy pregnant women who
      had normal amniotic fluid volume (the control group)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: amniotic fluid index
time frame: two hours
measure: fetal renal artery doppler indices
time frame: two hours
arm group label: the study group
arm group type: Active Comparator
description: healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee
arm group label: the control group
arm group type: No Intervention
description: healthy pregnant women with normal amniotic volume
intervention type: Dietary Supplement
intervention name: coffee
description: 2 g Nescafe Clasico contains approximately 65 mg caffeine
arm group label: the study group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: YUSUF MADENDAĞ
role: Principal Investigator
affiliation: Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Yusuf MADENDAG
investigator title: obstetrics and gynecology