<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/NCT03251833</url>
  </required_header>
  <id_info>
    <org_study_id>OMP</org_study_id>
    <nct_id>NCT03251833</nct_id>
  </id_info>
  <brief_title>The Impact of Obesity on Maternal and Perinatal Outcomes</brief_title>
  <official_title>The Impact of Obesity on Maternal and Perinatal Outcomes; Analytic Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Body Mass Index is an index that is commonly used to classify underweight, overweight and&#xD;
      obesity in adults. It is defined as the weight in kilograms divided by the square of the&#xD;
      height in meters.The growing epidemic of obesity in our society has become a major public&#xD;
      health issue where the proportion of overweight and obese among women aged 15-59 have&#xD;
      increased from 68 percent in 2008 to 76 percent in 2015&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 4, 2018</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of preeclampsia in both groups</measure>
    <time_frame>24 hours</time_frame>
    <description>The number of women who develop hypertension with proteinuria in pregnancy</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>obese</arm_group_label>
    <description>Body mass index &gt;30 Kilogram/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-obese</arm_group_label>
    <description>Body mass index &lt;30 Kilogram/m2</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women admitted to the emergency unit of Obstetrics and Gynaecology Department, Woman's&#xD;
        Health Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  single fetus&#xD;
&#xD;
          -  gestational age &gt;28weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  multifetal pregnancy&#xD;
&#xD;
          -  Medical illness prior to pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Norhan Tarek, MBBCh</last_name>
    <phone>00201091467612</phone>
    <email>noor.647@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Abbas, MD</last_name>
      <phone>00201003385183</phone>
      <email>bmr90@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</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>Obesity</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/NCT03251833
org study id: OMP
nct id: NCT03251833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Body Mass Index is an index that is commonly used to classify underweight, overweight and
      obesity in adults. It is defined as the weight in kilograms divided by the square of the
      height in meters.The growing epidemic of obesity in our society has become a major public
      health issue where the proportion of overweight and obese among women aged 15-59 have
      increased from 68 percent in 2008 to 76 percent in 2015
observational model: Other
time perspective: Cross-Sectional
measure: The incidence of preeclampsia in both groups
time frame: 24 hours
description: The number of women who develop hypertension with proteinuria in pregnancy
arm group label: obese
description: Body mass index >30 Kilogram/m2
arm group label: non-obese
description: Body mass index <30 Kilogram/m2
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Norhan Tarek, MBBCh
phone: 00201091467612
email: noor.647@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: principal investigator
mesh term: Obesity
sharing ipd: No