<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/NCT03764696</url>
  </required_header>
  <id_info>
    <org_study_id>CYH002</org_study_id>
    <nct_id>NCT03764696</nct_id>
  </id_info>
  <brief_title>Maternal Oxygen Administration for Fetal Distress II</brief_title>
  <official_title>The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navy General Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Navy General Hospital, Beijing</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>
      Supplementary oxygen is routinely administered to patients, even those with adequate oxygen&#xD;
      saturations, in the belief that it increases oxygen delivery. However, oxygen delivery&#xD;
      depends not just on arterial oxygen content but also on perfusion.&#xD;
&#xD;
      Maternal oxygen administration has been used in an attempt to lessen fetal distress by&#xD;
      increasing the available oxygen from the mother. However, the effect of supplemental maternal&#xD;
      oxygen therapy on fetal acid base status has been debated for more than seven decades.&#xD;
&#xD;
      The investigators found the use of 2 L/min maternal oxygen during the second stage of labor&#xD;
      did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR)&#xD;
      pattern distribution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cord arterial pH values</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord arterial partial pressure of oxygen</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord arterial partial pressure of carbon dioxide</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord venous pH values</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord venous partial pressure of oxygen</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord venous partial pressure of carbon dioxide</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of abnormal fetal heart tracing</measure>
    <time_frame>at 1 minute after birth</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of cesarean delivery</measure>
    <time_frame>at 1 minute after birth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of assisted vaginal delivery</measure>
    <time_frame>at 1 minute after birth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Apgar score less than 7</measure>
    <time_frame>at 1 and 5 minutes after birth</time_frame>
    <description>The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar score ranges from 0 to 10. The five criteria are summarized using words chosen (Appearance, Pulse, Grimace, Activity, Respiration). The infant is given a score of 0, 1 or 2. The scores are added up and the total sum is their Apgar score.&#xD;
The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of serious neonatal morbidity or death</measure>
    <time_frame>within 28 days of birth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cord arterial plasma liquid chromatography mass spectrometry analysis</measure>
    <time_frame>within 30 to 60 seconds of birth</time_frame>
    <description>The systematic identification and quantitation of all the metabolic products (mainly endogenous small molecule compounds with relative molecular weight within 1000 Da) of cord arterial plasma under oxygen and room air conditions. Immediately after delivery (within 30-60 seconds of birth), blood plasma sample will be obtained.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Oxygen Inhalation Therapy</condition>
  <condition>Labour</condition>
  <condition>Fetal Distress</condition>
  <arm_group>
    <arm_group_label>air, the first and second stage of labor</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the group will receive room air.&#xD;
The therapy will continue until after delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxygen, the first and second stage of labor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen.&#xD;
The therapy will continue until after delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tight-fitting simple facemask</intervention_name>
    <description>Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery</description>
    <arm_group_label>oxygen, the first and second stage of labor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        at term (&gt;37 weeks, &lt;42 weeks), singleton, cephalic presentation, spontaneous or induced&#xD;
        labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in&#xD;
        nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational&#xD;
        diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction,&#xD;
        placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid,&#xD;
        tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia,&#xD;
        fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations,&#xD;
        hypotension, uncomfortable with facemask.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunhai Chuai, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth Medical Center, Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fang Chuai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth Medical Center, Chinese PLA General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Sixth Medical Center, Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chuai F, Dong T, Liu Y, Jiang W, Zhang L, Chen L, Chuai Y, Zhou Y. The effect of intrapartum prolonged oxygen exposure on fetal metabolic status: secondary analysis from a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1204956. doi: 10.3389/fendo.2023.1204956. eCollection 2023.</citation>
    <PMID>37441500</PMID>
  </reference>
  <reference>
    <citation>Chuai Y, Jiang W, Zhang L, Chuai F, Sun X, Peng K, Gao J, Dong T, Chen L, Yao Y. Effect of long-duration oxygen vs room air during labor on umbilical cord venous partial pressure of oxygen: a randomized controlled trial. Am J Obstet Gynecol. 2022 Oct;227(4):629.e1-629.e16. doi: 10.1016/j.ajog.2022.05.028. Epub 2022 May 14.</citation>
    <PMID>35580635</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 13, 2023</last_update_submitted>
  <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Navy General Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Yunhai Chuai</investigator_full_name>
    <investigator_title>Clinical Professor of Obstetrics and Gynecology, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Distress</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/NCT03764696
org study id: CYH002
nct id: NCT03764696
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Supplementary oxygen is routinely administered to patients, even those with adequate oxygen
      saturations, in the belief that it increases oxygen delivery. However, oxygen delivery
      depends not just on arterial oxygen content but also on perfusion.

      Maternal oxygen administration has been used in an attempt to lessen fetal distress by
      increasing the available oxygen from the mother. However, the effect of supplemental maternal
      oxygen therapy on fetal acid base status has been debated for more than seven decades.

      The investigators found the use of 2 L/min maternal oxygen during the second stage of labor
      did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR)
      pattern distribution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cord arterial pH values
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Cord arterial partial pressure of oxygen
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Cord arterial partial pressure of carbon dioxide
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Cord venous pH values
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Cord venous partial pressure of oxygen
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Cord venous partial pressure of carbon dioxide
time frame: within 30 to 60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.
measure: Rate of abnormal fetal heart tracing
time frame: at 1 minute after birth
measure: Rate of cesarean delivery
time frame: at 1 minute after birth
measure: Rate of assisted vaginal delivery
time frame: at 1 minute after birth
measure: Apgar score less than 7
time frame: at 1 and 5 minutes after birth
description: The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar score ranges from 0 to 10. The five criteria are summarized using words chosen (Appearance, Pulse, Grimace, Activity, Respiration). The infant is given a score of 0, 1 or 2. The scores are added up and the total sum is their Apgar score.
The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
measure: Rate of serious neonatal morbidity or death
time frame: within 28 days of birth
measure: Cord arterial plasma liquid chromatography mass spectrometry analysis
time frame: within 30 to 60 seconds of birth
description: The systematic identification and quantitation of all the metabolic products (mainly endogenous small molecule compounds with relative molecular weight within 1000 Da) of cord arterial plasma under oxygen and room air conditions. Immediately after delivery (within 30-60 seconds of birth), blood plasma sample will be obtained.
arm group label: air, the first and second stage of labor
arm group type: No Intervention
description: Patients randomized to the group will receive room air.
The therapy will continue until after delivery
arm group label: oxygen, the first and second stage of labor
arm group type: Experimental
description: Patients randomized to the group will receive oxygen administered by high flow facemask oxygen at 10 L/min oxygen.
The therapy will continue until after delivery
intervention type: Device
intervention name: tight-fitting simple facemask
description: Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
arm group label: oxygen, the first and second stage of labor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yunhai Chuai, Dr
role: Principal Investigator
affiliation: Sixth Medical Center, Chinese PLA General Hospital
last name: Fang Chuai
role: Principal Investigator
affiliation: Sixth Medical Center, Chinese PLA General Hospital
facility: 
facility: 
facility: 
country: China
citation: Chuai F, Dong T, Liu Y, Jiang W, Zhang L, Chen L, Chuai Y, Zhou Y. The effect of intrapartum prolonged oxygen exposure on fetal metabolic status: secondary analysis from a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1204956. doi: 10.3389/fendo.2023.1204956. eCollection 2023.
PMID: 37441500
citation: Chuai Y, Jiang W, Zhang L, Chuai F, Sun X, Peng K, Gao J, Dong T, Chen L, Yao Y. Effect of long-duration oxygen vs room air during labor on umbilical cord venous partial pressure of oxygen: a randomized controlled trial. Am J Obstet Gynecol. 2022 Oct;227(4):629.e1-629.e16. doi: 10.1016/j.ajog.2022.05.028. Epub 2022 May 14.
PMID: 35580635
responsible party type: Principal Investigator
investigator affiliation: Navy General Hospital, Beijing
investigator full name: Yunhai Chuai
investigator title: Clinical Professor of Obstetrics and Gynecology, Principal Investigator
mesh term: Fetal Distress