<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/NCT03771976</url>
  </required_header>
  <id_info>
    <org_study_id>MHST-2014-05</org_study_id>
    <nct_id>NCT03771976</nct_id>
  </id_info>
  <brief_title>Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.</brief_title>
  <official_title>Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Thomas Hospital, Panama</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Thomas Hospital, Panama</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>
      The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period&#xD;
      and compared two cohorts of patients (primiparous women over 35 years of age and primiparous&#xD;
      woman between 20 and 34 years of age). The objective was to determine the risk of cesarean&#xD;
      section and other perinatal complications between the groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Risk of cesarean section</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of cesarean sections (birth by cesarean section), independent of the reason.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perinatal complications</measure>
    <time_frame>5 years</time_frame>
    <description>Any combination of perinatal complications (Stillbirth, low apgar score) between groups.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">572</enrollment>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Over 35 years of age</arm_group_label>
    <description>Primiparous women over 35 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Between 20-34 years of age</arm_group_label>
    <description>Primiparous women between 20 and 34 years of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cesarean section</intervention_name>
    <description>Risk of cesarean section between the cohorts</description>
    <arm_group_label>Between 20-34 years of age</arm_group_label>
    <arm_group_label>Over 35 years of age</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No cesarean section</intervention_name>
    <description>Vaginal birth rate between the cohorts</description>
    <arm_group_label>Between 20-34 years of age</arm_group_label>
    <arm_group_label>Over 35 years of age</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primiparous women, between 22 and 42 weeks of gestation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant Primiparous women.&#xD;
&#xD;
          -  Birth after 22 weeks and neonatal weight &gt; 501g.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparity.&#xD;
&#xD;
          -  Birth before 22 weeks or neonatal weight &lt; 500g.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saint Thomas H</name>
      <address>
        <city>Panama</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Thomas Hospital, Panama</investigator_affiliation>
    <investigator_full_name>Osvaldo A. Reyes T.</investigator_full_name>
    <investigator_title>Chairman of Research - Saint Thomas Maternity Hospital</investigator_title>
  </responsible_party>
  <keyword>Older women (&gt;35 years of age)</keyword>
  <keyword>Primipara</keyword>
  <keyword>Cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual data. Just the final results.</ipd_description>
  </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/NCT03771976
org study id: MHST-2014-05
nct id: NCT03771976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period
      and compared two cohorts of patients (primiparous women over 35 years of age and primiparous
      woman between 20 and 34 years of age). The objective was to determine the risk of cesarean
      section and other perinatal complications between the groups.
observational model: Cohort
time perspective: Retrospective
measure: Risk of cesarean section
time frame: 5 years
description: Rate of cesarean sections (birth by cesarean section), independent of the reason.
measure: Perinatal complications
time frame: 5 years
description: Any combination of perinatal complications (Stillbirth, low apgar score) between groups.
arm group label: Over 35 years of age
description: Primiparous women over 35 years of age.
arm group label: Between 20-34 years of age
description: Primiparous women between 20 and 34 years of age.
intervention type: Procedure
intervention name: Cesarean section
description: Risk of cesarean section between the cohorts
arm group label: Between 20-34 years of age
arm group label: Over 35 years of age
intervention type: Procedure
intervention name: No cesarean section
description: Vaginal birth rate between the cohorts
arm group label: Between 20-34 years of age
arm group label: Over 35 years of age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Panama
responsible party type: Principal Investigator
investigator affiliation: Saint Thomas Hospital, Panama
investigator full name: Osvaldo A. Reyes T.
investigator title: Chairman of Research - Saint Thomas Maternity Hospital
mesh term: Pregnancy Complications
sharing ipd: No
ipd description: No plan to share individual data. Just the final results.