<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/NCT03029117</url>
  </required_header>
  <id_info>
    <org_study_id>12345</org_study_id>
    <nct_id>NCT03029117</nct_id>
  </id_info>
  <brief_title>Effect of Rheumatic Heart Disease on Maternal and Fetal Outcomes</brief_title>
  <official_title>Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes</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>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>
      It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females&#xD;
      between corrected and uncorrected rheumatic valve lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart disease is one of the most important medical complications during pregnancy as it is&#xD;
      one of the common, indirect obstetric causes of maternal death. Approximately 1% of&#xD;
      pregnancies are complicated by cardiac disease .&#xD;
&#xD;
      Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a&#xD;
      chronic acquired heart disorder resulting from acute rheumatic fever. In developing&#xD;
      countries, RHD continues to be a major cause of cardiac morbidity and mortality especially&#xD;
      among young adult females In pregnancies complicated with cardiac disorders, maternal and&#xD;
      perinatal mortality and morbidity depend on the type of disorder, the functional status of&#xD;
      the patient and the complications associated with the pregnancy.&#xD;
&#xD;
      Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease,&#xD;
      remains the most common acquired valvular lesion in pregnant women and the most common cause&#xD;
      of maternal death from cardiac causes .&#xD;
&#xD;
      Although mortality is not high in women, the rate of fetal morbidity rises with the severity&#xD;
      of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women&#xD;
      with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area&#xD;
      &lt;1.5 CM2).&#xD;
&#xD;
      In the second and third trimesters, when maternal blood volume and cardiac output peak, heart&#xD;
      failure may occur in pregnant women with moderate or severe mitral stenosis, even in&#xD;
      previously asymptomatic women .&#xD;
&#xD;
      The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%,&#xD;
      fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).&#xD;
&#xD;
      The advancement in cardiology and obstetrics has provided major improvements in the&#xD;
      management of pregnant patients with cardiac disorders. Now we are facing more women with&#xD;
      previous history of surgical correction of rheumatic heart disease.&#xD;
&#xD;
      Vaginal delivery is considered In women with mild mitral stenosis, and in patients with&#xD;
      moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart&#xD;
      Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered&#xD;
      Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class&#xD;
      III-IV symptoms, or who have pulmonary hypertension despite medical therapy.&#xD;
&#xD;
      Therapeutic options for in women with rheumatic heart disease include both medical and&#xD;
      surgical alternatives, as well as catheter-based interventions The choice dependent on the&#xD;
      degree of valvular affection and patient symptoms. There are few studies that compare the&#xD;
      Maternal and fetal outcomes in women with rheumatic heart disease between patient with&#xD;
      corrected and uncorrected valve lesions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>maternal morbidity</measure>
    <time_frame>40 days after delivery</time_frame>
    <description>compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fetal outcome</measure>
    <time_frame>first 1 day after delivery</time_frame>
    <description>compare birth weight and need for admission at neonatal intensive care unit (NICU) between corrected and uncorrected valve lesions in pregnant women</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Rheumatic; Heart Disease, Maternal, Affecting Fetus</condition>
  <arm_group>
    <arm_group_label>corrected and uncorrected rheumatic valve lesions</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>correction of rheumatic valve lesions</intervention_name>
    <arm_group_label>corrected and uncorrected rheumatic valve lesions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant females with rheumatic heart disease come for antenatal care at out patient clinic&#xD;
        at tertiary obstetric center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant females with rheumatic heart disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other heart diseases ( cardiomyopathy , myocardial infarction ...etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Armia Michael</investigator_full_name>
    <investigator_title>resident physician</investigator_title>
  </responsible_party>
  <keyword>rheumatic pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Heart Diseases</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/NCT03029117
org study id: 12345
nct id: NCT03029117
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females
      between corrected and uncorrected rheumatic valve lesions
Heart disease is one of the most important medical complications during pregnancy as it is
      one of the common, indirect obstetric causes of maternal death. Approximately 1% of
      pregnancies are complicated by cardiac disease .

      Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a
      chronic acquired heart disorder resulting from acute rheumatic fever. In developing
      countries, RHD continues to be a major cause of cardiac morbidity and mortality especially
      among young adult females In pregnancies complicated with cardiac disorders, maternal and
      perinatal mortality and morbidity depend on the type of disorder, the functional status of
      the patient and the complications associated with the pregnancy.

      Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease,
      remains the most common acquired valvular lesion in pregnant women and the most common cause
      of maternal death from cardiac causes .

      Although mortality is not high in women, the rate of fetal morbidity rises with the severity
      of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women
      with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area
      <1.5 CM2).

      In the second and third trimesters, when maternal blood volume and cardiac output peak, heart
      failure may occur in pregnant women with moderate or severe mitral stenosis, even in
      previously asymptomatic women .

      The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%,
      fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).

      The advancement in cardiology and obstetrics has provided major improvements in the
      management of pregnant patients with cardiac disorders. Now we are facing more women with
      previous history of surgical correction of rheumatic heart disease.

      Vaginal delivery is considered In women with mild mitral stenosis, and in patients with
      moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart
      Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered
      Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class
      III-IV symptoms, or who have pulmonary hypertension despite medical therapy.

      Therapeutic options for in women with rheumatic heart disease include both medical and
      surgical alternatives, as well as catheter-based interventions The choice dependent on the
      degree of valvular affection and patient symptoms. There are few studies that compare the
      Maternal and fetal outcomes in women with rheumatic heart disease between patient with
      corrected and uncorrected valve lesions
observational model: Cohort
time perspective: Prospective
measure: maternal morbidity
time frame: 40 days after delivery
description: compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women
measure: Fetal outcome
time frame: first 1 day after delivery
description: compare birth weight and need for admission at neonatal intensive care unit (NICU) between corrected and uncorrected valve lesions in pregnant women
arm group label: corrected and uncorrected rheumatic valve lesions
intervention type: Procedure
intervention name: correction of rheumatic valve lesions
arm group label: corrected and uncorrected rheumatic valve lesions
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Armia Michael
investigator title: resident physician
mesh term: Rheumatic Diseases
mesh term: Heart Diseases
sharing ipd: No