<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/NCT03757780</url>
  </required_header>
  <id_info>
    <org_study_id>low birth weight</org_study_id>
    <nct_id>NCT03757780</nct_id>
  </id_info>
  <brief_title>Low Birth Weight Fetuses With Caffeine Use</brief_title>
  <official_title>Association of Low Birth Weight Fetuses With Caffeine Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aljazeera Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined&#xD;
      as birthweight less than 2,500 g .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low birth weight is not only associated with neonatal mortality and morbidity.&#xD;
&#xD;
      but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular&#xD;
      diseases in adult life&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Anticipated">February 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of pregnant ladies who will have low birth weight babies</measure>
    <time_frame>within 2 months</time_frame>
    <description>Mothers who will give birth to low birth weight infants</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Low; Birthweight, Extremely (999 Grams or Less)</condition>
  <arm_group>
    <arm_group_label>Pregnant ladies who are caffeine using</arm_group_label>
    <description>ladies who uses caffeine during pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionaire</intervention_name>
    <description>A questionaire will be made to pregnant ladies who take caffeine during pregnancy</description>
    <arm_group_label>Pregnant ladies who are caffeine using</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Age group: 18-40&#xD;
&#xD;
        •Pregnant females attending regular post-natal care visits&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age group: 18-40&#xD;
&#xD;
          -  Pregnant females attending regular post-natal care visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Female patients with other acute or chronic illness&#xD;
&#xD;
               -  Cardiovascular disease&#xD;
&#xD;
               -  Neoplasms&#xD;
&#xD;
               -  Current diabetes mellitus, pregnancy induced diabetes&#xD;
&#xD;
               -  Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood&#xD;
                  pressure 140/85 mm Hg).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>• pregnant women with age group between : 18-40</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy</last_name>
    <role>Study Chair</role>
    <affiliation>Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud Alalfy</last_name>
    <phone>01002611058</phone>
    <email>mahmoudalalfy@ymail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Algazeerah and Kasralainy hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahmoud Alalfy, master</last_name>
      <phone>+201002611058</phone>
      <email>mahmoudalalfy@ymail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed Elgazzar, M.D</last_name>
      <phone>+201014005959</phone>
    </contact_backup>
    <investigator>
      <last_name>Mahmoud Alalfy, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Birth Weight</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/NCT03757780
org study id: low birth weight
nct id: NCT03757780
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined
      as birthweight less than 2,500 g .
Low birth weight is not only associated with neonatal mortality and morbidity.

      but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular
      diseases in adult life
observational model: Cohort
time perspective: Retrospective
measure: The number of pregnant ladies who will have low birth weight babies
time frame: within 2 months
description: Mothers who will give birth to low birth weight infants
arm group label: Pregnant ladies who are caffeine using
description: ladies who uses caffeine during pregnancy
intervention type: Other
intervention name: Questionaire
description: A questionaire will be made to pregnant ladies who take caffeine during pregnancy
arm group label: Pregnant ladies who are caffeine using
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: • pregnant women with age group between : 18-40
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy
role: Study Chair
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
last name: Mahmoud Alalfy
phone: 01002611058
email: mahmoudalalfy@ymail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Sponsor
mesh term: Birth Weight
sharing ipd: No