<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/NCT01677364</url>
  </required_header>
  <id_info>
    <org_study_id>7862/PG/2Trg/08</org_study_id>
    <nct_id>NCT01677364</nct_id>
  </id_info>
  <brief_title>Elective Induction vs Spontaneous Labour in Patients With Heart Disease</brief_title>
  <official_title>ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <brief_summary>
    <textblock>
      Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were&#xD;
      randomised into elective induction and spontaneous labour groups only after bishop score was&#xD;
      equal to or more than 6.It was concluded that induction of labour with oxytocin is a&#xD;
      relatively safe procedure in women with low risk heart disease with NYHA class I and II. It&#xD;
      resulted in a similar caesarean delivery rate and was not associated with more maternal and&#xD;
      neonatal complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml&#xD;
      normal saline was prepared and given through infusion pump at initial rate of 3mU/min.&#xD;
      Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were&#xD;
      established.&#xD;
&#xD;
      Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given&#xD;
      intravenously for pain relief.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of labour</measure>
    <time_frame>at the time of delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of caesarean section</measure>
    <time_frame>at the time of delivery</time_frame>
    <description>mode of delivery and rate of caesarean section with indication</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with delivery during workday hours</measure>
    <time_frame>at the time of delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patients with maternal complications</measure>
    <time_frame>day 5</time_frame>
    <description>maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with adverse neonatal outcome</measure>
    <time_frame>day 5</time_frame>
    <description>apgar score number of admissions to neonatal intensive care unit number of neonatal deaths</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Heart; Disease,Complicating Pregnancy, Pre-existing</condition>
  <arm_group>
    <arm_group_label>induction of labour</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spontaneous Labour</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients were allowed to go into spontaneous labour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Arm - Induction of labour</description>
    <arm_group_label>induction of labour</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NYHA class I-II&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  singleton gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous cesarean section,&#xD;
&#xD;
          -  Primary pulmonary hypertension,&#xD;
&#xD;
          -  Eisenmenger syndrome,&#xD;
&#xD;
          -  Marfan syndrome,&#xD;
&#xD;
          -  Left heart obstruction,&#xD;
&#xD;
          -  Prior cardiac event or arrhythmia,&#xD;
&#xD;
          -  Malformed fetus,&#xD;
&#xD;
          -  Severe anemia (&lt;7g/dl),&#xD;
&#xD;
          -  Intrauterine fetal death,&#xD;
&#xD;
          -  other obstetrical indications for induction of labour&#xD;
&#xD;
          -  patients on anticoagulation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr.Yogita Dogra</investigator_full_name>
    <investigator_title>Dr.Yogita Dogra</investigator_title>
  </responsible_party>
  <keyword>induction of labour</keyword>
  <keyword>heart disease patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_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/NCT01677364
org study id: 7862/PG/2Trg/08
nct id: NCT01677364
lead sponsor: 
Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were
      randomised into elective induction and spontaneous labour groups only after bishop score was
      equal to or more than 6.It was concluded that induction of labour with oxytocin is a
      relatively safe procedure in women with low risk heart disease with NYHA class I and II. It
      resulted in a similar caesarean delivery rate and was not associated with more maternal and
      neonatal complications.
Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml
      normal saline was prepared and given through infusion pump at initial rate of 3mU/min.
      Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were
      established.

      Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given
      intravenously for pain relief.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of labour
time frame: at the time of delivery
measure: Rate of caesarean section
time frame: at the time of delivery
description: mode of delivery and rate of caesarean section with indication
measure: Number of patients with delivery during workday hours
time frame: at the time of delivery
measure: number of patients with maternal complications
time frame: day 5
description: maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
measure: number of patients with adverse neonatal outcome
time frame: day 5
description: apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
arm group label: induction of labour
arm group type: Active Comparator
description: drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min
arm group label: Spontaneous Labour
arm group type: No Intervention
description: patients were allowed to go into spontaneous labour
intervention type: Drug
intervention name: Oxytocin
description: Arm - Induction of labour
arm group label: induction of labour
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 37 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr.Yogita Dogra
investigator title: Dr.Yogita Dogra
mesh term: Pregnancy Complications
mesh term: Heart Diseases
mesh term: Oxytocin