<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/NCT04461704</url>
  </required_header>
  <id_info>
    <org_study_id>NSD-TW-01</org_study_id>
    <nct_id>NCT04461704</nct_id>
  </id_info>
  <brief_title>To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women</brief_title>
  <official_title>To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CJshine Technology Company Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CJshine Technology Company Ltd.</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>
      Analysis of monitored clinically parameters during the course of labor is a seldom studied&#xD;
      area in Taiwan and worldwide. Important monitored parameters include, fetal heartbeat,&#xD;
      uterine contractions, oxygen saturation and blood pressure, among others.1 During labor,&#xD;
      uterine contractions can cause pain.3 This pain may be measured using a visual analogue scale&#xD;
      (VAS).2 The pain from uterine contractions promotes the release of hormones including&#xD;
      cortisol which can cause decreased or irregular contractions and possibly prolong labor.3&#xD;
      This study aims to study the association between monitored clinical parameters and pain in&#xD;
      women in Taiwan during labor in order to increase the understanding to safe childbirth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, observational study to measure and collect and physical parameters&#xD;
      from females at least 20 years of age in the labor room. Collection of measurements and&#xD;
      physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2&#xD;
      will be recorded continuously until the end of the study period. In addition, uterus&#xD;
      contraction cycle and fetal heart beat will be recorded during the study period based on&#xD;
      standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at&#xD;
      baseline and when the caregiver perceives that there is a change in the subject's pain status&#xD;
      until the end of the study period. The time of each assessment of pain on VAS should be&#xD;
      recorded. Subjects will be withdrawn from the study if they have a cesarean section or any&#xD;
      complication during labor in the opinion of the investigator. Subject participation in the&#xD;
      study will end when eight hours have elapsed since baseline, the subject leaves the labor&#xD;
      room or the subject delivers the baby.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To detect the association between labor pain and related physical parameters during labor progression</measure>
    <time_frame>Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby</time_frame>
    <description>Collection of measurements and physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2 will be recorded continuously until the end of the study period. In addition, uterus contraction cycle and fetal heart beat will be recorded during the study period based on standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at baseline and when the caregiver perceives that there is a change in the subject's pain status until the end of the study period. The time of each assessment of pain on VAS should be recorded. Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator. Subject participation in the study will end when eight hours have elapsed since baseline, the subject leaves the labor room or the subject delivers the baby.</description>
  </primary_outcome>
  <enrollment type="Actual">16</enrollment>
  <condition>Labor Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Maternity at least 20 years of age in the labor room&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female at least 20 years of age.&#xD;
&#xD;
          2. Have a course of labor that is &gt; 4 hours.&#xD;
&#xD;
          3. American Society of Anesthesiologists Physical Status (ASA PS) Classification of Class&#xD;
             I-II.&#xD;
&#xD;
          4. Clinical records of the subject are complete in the opinion of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subject has any condition, which in the opinion of the investigator precludes the&#xD;
        subject's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</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/NCT04461704
org study id: NSD-TW-01
nct id: NCT04461704
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Analysis of monitored clinically parameters during the course of labor is a seldom studied
      area in Taiwan and worldwide. Important monitored parameters include, fetal heartbeat,
      uterine contractions, oxygen saturation and blood pressure, among others.1 During labor,
      uterine contractions can cause pain.3 This pain may be measured using a visual analogue scale
      (VAS).2 The pain from uterine contractions promotes the release of hormones including
      cortisol which can cause decreased or irregular contractions and possibly prolong labor.3
      This study aims to study the association between monitored clinical parameters and pain in
      women in Taiwan during labor in order to increase the understanding to safe childbirth.
This is a prospective, observational study to measure and collect and physical parameters
      from females at least 20 years of age in the labor room. Collection of measurements and
      physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2
      will be recorded continuously until the end of the study period. In addition, uterus
      contraction cycle and fetal heart beat will be recorded during the study period based on
      standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at
      baseline and when the caregiver perceives that there is a change in the subject's pain status
      until the end of the study period. The time of each assessment of pain on VAS should be
      recorded. Subjects will be withdrawn from the study if they have a cesarean section or any
      complication during labor in the opinion of the investigator. Subject participation in the
      study will end when eight hours have elapsed since baseline, the subject leaves the labor
      room or the subject delivers the baby.
observational model: Case-Only
time perspective: Prospective
measure: To detect the association between labor pain and related physical parameters during labor progression
time frame: Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby
description: Collection of measurements and physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2 will be recorded continuously until the end of the study period. In addition, uterus contraction cycle and fetal heart beat will be recorded during the study period based on standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at baseline and when the caregiver perceives that there is a change in the subject's pain status until the end of the study period. The time of each assessment of pain on VAS should be recorded. Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator. Subject participation in the study will end when eight hours have elapsed since baseline, the subject leaves the labor room or the subject delivers the baby.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Labor Pain