<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/NCT03043937</url>
  </required_header>
  <id_info>
    <org_study_id>1200</org_study_id>
    <nct_id>NCT03043937</nct_id>
  </id_info>
  <brief_title>Cardiac Diseases With Pregnancy in Benisuef Localities</brief_title>
  <official_title>Cardiac Diseases With Pregnancy in Benisuef Localities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to demonstrate the variation of cardiac diseases among pregnant&#xD;
      ladies in our localities, detect maternal &amp; fetal complications and to predict the risk&#xD;
      factors for poor maternal, fetal &amp; neonatal outcomes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Fetomaternal and neonatal outcome</measure>
    <time_frame>2 years</time_frame>
    <description>Number of Participants With abortion,preterm labour,Intrauterine fetal death,Postterm fetus, intrauterine growth restriction,Fetuses with Congenital heart diseases,Neonatal admission to Neonatal Intensive care unit,neonatal death,Perineal,vaginal,broad ligament haematoma, Internal Hemorrhage due to anticoagulant drugs,malfunctioning valve,heart failure ,Thromboembolic complications, perinatal maternal death.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Heart Disease Structural Disorder Abscess of Cardiac Septum</condition>
  <arm_group>
    <arm_group_label>cardiac patients WHO class 1,2</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>cardiac patients WHO class 3,4</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>registry</intervention_name>
    <arm_group_label>cardiac patients WHO class 1,2</arm_group_label>
    <arm_group_label>cardiac patients WHO class 3,4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A prospective analytical study is managed to be commenced in Beni-Suef governorate as&#xD;
        cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology&#xD;
        Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with&#xD;
        cardiac diseases during pregnancy regardless gestational age at presentation and up till 6&#xD;
        weeks postpartum in comparison to women free from any cardiac diseases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart&#xD;
             disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary&#xD;
             hypertension, presenting with pregnancy regardless age, any concomitant diseases and&#xD;
             type of heart disease will be enrolled.&#xD;
&#xD;
          -  A similar number of pregnant females free from previous mentioned cardiac diseases&#xD;
             will be studied as controls.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Benisuef</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>May 18, 2017</last_update_submitted>
  <last_update_submitted_qc>May 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Momen Zakaria Mohammed mohammed</investigator_full_name>
    <investigator_title>assisstant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</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/NCT03043937
org study id: 1200
nct id: NCT03043937
lead sponsor: 
has dmc: Yes
The aim of this work is to demonstrate the variation of cardiac diseases among pregnant
      ladies in our localities, detect maternal & fetal complications and to predict the risk
      factors for poor maternal, fetal & neonatal outcomes
observational model: Other
time perspective: Prospective
measure: Fetomaternal and neonatal outcome
time frame: 2 years
description: Number of Participants With abortion,preterm labour,Intrauterine fetal death,Postterm fetus, intrauterine growth restriction,Fetuses with Congenital heart diseases,Neonatal admission to Neonatal Intensive care unit,neonatal death,Perineal,vaginal,broad ligament haematoma, Internal Hemorrhage due to anticoagulant drugs,malfunctioning valve,heart failure ,Thromboembolic complications, perinatal maternal death.
arm group label: cardiac patients WHO class 1,2
arm group label: cardiac patients WHO class 3,4
intervention type: Other
intervention name: registry
arm group label: cardiac patients WHO class 1,2
arm group label: cardiac patients WHO class 3,4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Momen Zakaria Mohammed mohammed
investigator title: assisstant lecturer
mesh term: Heart Diseases