<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/NCT02989337</url>
  </required_header>
  <id_info>
    <org_study_id>2016/579</org_study_id>
    <nct_id>NCT02989337</nct_id>
  </id_info>
  <brief_title>Endothelial Dysfunction in Hyperemesis Gravidarum</brief_title>
  <official_title>Endothelial Dysfunction in Hyperemesis Gravidarum</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>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine serum inflammatory adhesion molecules levels in&#xD;
      hyperemesis gravidarum&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population consisted of 2 groups; (1) the hyperemesis gravidarum group, consist of&#xD;
      25 pregnant women who developed dehydration due to HG between 6 and 13 gestational weeks and&#xD;
      between 18 and 35 years (2) the normal pregnancy group, consisting of 25 pregnant women.&#xD;
&#xD;
      HG was defined according to the fallowing American College of Obstetricians and Gynecologists&#xD;
      (ACOG) criteria; severe nausea and vomiting resulted in 5% weight loss with regard to&#xD;
      pre-gestation or vomiting more than 3 times and 3-5 % weight loss with ketonuria. The&#xD;
      diagnosis of dehydration was clinically defined and patients with moderate and severe&#xD;
      dehydration were included in the study. As clinical findings; Weight loss, capillary recall&#xD;
      time, dry mucous membranes, dry eye, pulse rate, systolic blood pressure, respiration, skin&#xD;
      turgor deterioration and urine output were evaluated.&#xD;
&#xD;
      Other pathologies causing nausea and vomiting like; gastroenteritis, gastroparesis, gall duct&#xD;
      diseases, hepatitis, peptic ulcers, appendicitis, pyelonephritis, ovarian torsion, urinary&#xD;
      tract stones, diabetic ketoacidosis, hyperthyroidism, hyperparathyroidism, migraine, pseudo&#xD;
      tumor cerebra, vestibular diseases were excluded from the study.Patients were excluded from&#xD;
      the study in the presence of pregestational diabetes chronic hypertension, chronic liver and&#xD;
      renal failure, preeclampsia history, multiple pregnancy, hyperlipidemia,&#xD;
      hypercholesterolemia, obesity, tobacco use, NSAID drug use, infection within the last three&#xD;
      months and surgery within the last month that could cause endothelial dysfunction.&#xD;
&#xD;
      Blood and urine specimens were collected from the patients with HG during hospitalization and&#xD;
      during regular clinic visits in control group. The 2mL of blood samples were withdrawn into&#xD;
      serum-separating tubes for the measurements of serum biochemical parameters and 2 mL blood&#xD;
      samples were withdrawn into EDTA containing tubes for measurement serum hemoglobin and&#xD;
      hematocrit levels. Early-morning urine samples were collected from study population. These&#xD;
      blood and urine samples were analyzed in same day for Kayseri Education and Research hospital&#xD;
      biochemical clinics. In addition 2mL of blood samples were withdrawn into serum-separating&#xD;
      tubes for analyzing serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels. All of the serum&#xD;
      were stored at -80°C in nonadsorbable tubes. After three months for stored first blood&#xD;
      sample, serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels were determined by an enzyme&#xD;
      linked immunosorbent assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum inflammatory adhesion molecules in hyperemesis gravidarum</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hyperemesis; Gravidarum, With Dehydration</condition>
  <arm_group>
    <arm_group_label>hyperemesis gravidarum with dehydration</arm_group_label>
    <description>The first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The control group was formed of the patients who were healthy pregnant women admitted to the clinic just for routine examination without any symptoms</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consisted of 2 groups; (1) the hyperemesis gravidarum group, consist&#xD;
        of 25 pregnant women who developed dehydration due to HG between 6 and 13 gestational weeks&#xD;
        and between 18 and 35 years (2) the normal pregnancy group, consisting of 25 pregnant&#xD;
        women.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6-13 gestational weeks&#xD;
&#xD;
          -  between 18-35 years of age&#xD;
&#xD;
          -  Single pregnancy&#xD;
&#xD;
          -  Dehydration due to HG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Other pathologies causing nausea and vomiting;&#xD;
&#xD;
          -  gastroenteritis&#xD;
&#xD;
          -  gastroparesis&#xD;
&#xD;
          -  gall duct diseases&#xD;
&#xD;
          -  hepatitis&#xD;
&#xD;
          -  peptic ulcers&#xD;
&#xD;
          -  appendicitis&#xD;
&#xD;
          -  pyelonephritis&#xD;
&#xD;
          -  urinary tract stones&#xD;
&#xD;
          -  hyperthyroidism&#xD;
&#xD;
          -  hyperparathyroidism&#xD;
&#xD;
          -  migraine&#xD;
&#xD;
          -  vestibular diseases&#xD;
&#xD;
        Patients were excluded from the study in the presence of parameters that may cause&#xD;
        endothelial dysfunction such as;&#xD;
&#xD;
          -  pregestational diabetes&#xD;
&#xD;
          -  chronic hypertension&#xD;
&#xD;
          -  chronic liver and renal failure&#xD;
&#xD;
          -  preeclampsia history&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  hyperlipidemia&#xD;
&#xD;
          -  hypercholesterolemia&#xD;
&#xD;
          -  obesity&#xD;
&#xD;
          -  tobacco use&#xD;
&#xD;
          -  NSAID drug use&#xD;
&#xD;
          -  infection within the last three months&#xD;
&#xD;
          -  surgery within the last month&#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>Erdem SAHİN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Training and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erdem SAHİN, Principal İnvestigator</last_name>
    <phone>+905321688683</phone>
    <email>erdemsahin07@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yusuf MADENDAG, Central Contact Backup</last_name>
    <phone>+905055011340</phone>
    <email>yusufmadendag@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kayseri Training and Research Hospital</name>
      <address>
        <city>Kayseri</city>
        <zip>38000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yusuf madendag</last_name>
      <phone>+905055011340</phone>
      <email>yusufmadedag@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</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>Erdem Sahin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hyperemesis Gravidarum</keyword>
  <keyword>Inflammatory adhesion molecules</keyword>
  <keyword>Dehydration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperemesis Gravidarum</mesh_term>
    <mesh_term>Dehydration</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/NCT02989337
org study id: 2016/579
nct id: NCT02989337
lead sponsor: 
The purpose of the study is to determine serum inflammatory adhesion molecules levels in
      hyperemesis gravidarum
The study population consisted of 2 groups; (1) the hyperemesis gravidarum group, consist of
      25 pregnant women who developed dehydration due to HG between 6 and 13 gestational weeks and
      between 18 and 35 years (2) the normal pregnancy group, consisting of 25 pregnant women.

      HG was defined according to the fallowing American College of Obstetricians and Gynecologists
      (ACOG) criteria; severe nausea and vomiting resulted in 5% weight loss with regard to
      pre-gestation or vomiting more than 3 times and 3-5 % weight loss with ketonuria. The
      diagnosis of dehydration was clinically defined and patients with moderate and severe
      dehydration were included in the study. As clinical findings; Weight loss, capillary recall
      time, dry mucous membranes, dry eye, pulse rate, systolic blood pressure, respiration, skin
      turgor deterioration and urine output were evaluated.

      Other pathologies causing nausea and vomiting like; gastroenteritis, gastroparesis, gall duct
      diseases, hepatitis, peptic ulcers, appendicitis, pyelonephritis, ovarian torsion, urinary
      tract stones, diabetic ketoacidosis, hyperthyroidism, hyperparathyroidism, migraine, pseudo
      tumor cerebra, vestibular diseases were excluded from the study.Patients were excluded from
      the study in the presence of pregestational diabetes chronic hypertension, chronic liver and
      renal failure, preeclampsia history, multiple pregnancy, hyperlipidemia,
      hypercholesterolemia, obesity, tobacco use, NSAID drug use, infection within the last three
      months and surgery within the last month that could cause endothelial dysfunction.

      Blood and urine specimens were collected from the patients with HG during hospitalization and
      during regular clinic visits in control group. The 2mL of blood samples were withdrawn into
      serum-separating tubes for the measurements of serum biochemical parameters and 2 mL blood
      samples were withdrawn into EDTA containing tubes for measurement serum hemoglobin and
      hematocrit levels. Early-morning urine samples were collected from study population. These
      blood and urine samples were analyzed in same day for Kayseri Education and Research hospital
      biochemical clinics. In addition 2mL of blood samples were withdrawn into serum-separating
      tubes for analyzing serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels. All of the serum
      were stored at -80°C in nonadsorbable tubes. After three months for stored first blood
      sample, serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels were determined by an enzyme
      linked immunosorbent assay.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Serum inflammatory adhesion molecules in hyperemesis gravidarum
time frame: 4 months
arm group label: hyperemesis gravidarum with dehydration
description: The first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration
arm group label: Control group
description: The control group was formed of the patients who were healthy pregnant women admitted to the clinic just for routine examination without any symptoms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erdem SAHİN
role: Principal Investigator
affiliation: Kayseri Training and Research Hospital
last name: Erdem SAHİN, Principal İnvestigator
phone: +905321688683
email: erdemsahin07@hotmail.com
last name: Yusuf MADENDAG, Central Contact Backup
phone: +905055011340
email: yusufmadendag@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Erdem Sahin
investigator title: Principal Investigator
mesh term: Hyperemesis Gravidarum
mesh term: Dehydration