<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/NCT04412915</url>
  </required_header>
  <id_info>
    <org_study_id>109050-F</org_study_id>
    <nct_id>NCT04412915</nct_id>
  </id_info>
  <brief_title>Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women</brief_title>
  <official_title>Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to&#xD;
      40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor&#xD;
      induction at more than 41+0 gestational weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to&#xD;
      August 31, 2019 were reviewed to explore the correlation between early induction of labor and&#xD;
      caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in&#xD;
      primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the&#xD;
      cesarean rate, compared with those receiving labor induction at more than 41+0 gestational&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">August 23, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</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>Cesarean rate rate</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2125</enrollment>
  <condition>Low Risk Pregnancy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labor induction</intervention_name>
    <description>Labor induction with oxytocin or prostagladin</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014&#xD;
        to August 31, 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  After 38 + 0 weeks of gestation&#xD;
&#xD;
          -  low-risk pregnant primiparas&#xD;
&#xD;
          -  singleton&#xD;
&#xD;
          -  nulliparous&#xD;
&#xD;
          -  &gt; 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Premature rupture of membranes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>primiparas</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief of Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <!-- 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/NCT04412915
org study id: 109050-F
nct id: NCT04412915
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to
      40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor
      induction at more than 41+0 gestational weeks.
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to
      August 31, 2019 were reviewed to explore the correlation between early induction of labor and
      caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in
      primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the
      cesarean rate, compared with those receiving labor induction at more than 41+0 gestational
      weeks.
observational model: Cohort
time perspective: Retrospective
measure: Cesarean rate rate
time frame: 10 years
intervention type: Other
intervention name: Labor induction
description: Labor induction with oxytocin or prostagladin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: primiparas
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief of Department of Obstetrics & Gynecology