<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/NCT02221440</url>
  </required_header>
  <id_info>
    <org_study_id>CYH001</org_study_id>
    <nct_id>NCT02221440</nct_id>
  </id_info>
  <brief_title>Maternal Oxygen Administration for Fetal Distress</brief_title>
  <official_title>Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress</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>
    <has_dmc>Yes</has_dmc>
  </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;
      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second&#xD;
      stage of labor can relieve fetal distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):&#xD;
&#xD;
      Too little evidence to show whether oxygen administration to the woman during labour is&#xD;
      beneficial to the baby.&#xD;
&#xD;
      Some babies show signs of distress, such as unusual heart rates or the passing of a bowel&#xD;
      motion (meconium) during their mother's labour. This may be caused by a lack of oxygen&#xD;
      passing from the woman to the baby through the placenta. Sometimes, women may be encouraged&#xD;
      to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen&#xD;
      available to the unborn baby. A review of two trials found too little evidence to show&#xD;
      whether oxygen administration to the woman during the second stage of labour is beneficial to&#xD;
      the baby. No trials of oxygen administration when the baby is showing signs of distress were&#xD;
      found. Further research is needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cord arterial pH values (hydrogen ion concentration) less than 7.2</measure>
    <time_frame>within 30-60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apgar score less than 7</measure>
    <time_frame>at one and five 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 to form a backronym (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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal radial arterial partial pressure of oxygen</measure>
    <time_frame>within 30-60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>umbilical cord venous partial pressure of oxygen</measure>
    <time_frame>within 30-60 seconds of birth</time_frame>
    <description>Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cesarean delivery rate</measure>
    <time_frame>during the second stage of labor</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>assisted vaginal delivery</measure>
    <time_frame>during the second stage of labor</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>maternal dissatisfaction</measure>
    <time_frame>during the second stage of labor</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>abnormal fetal heart rate tracing</measure>
    <time_frame>during the second stage of labor</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>neonatal resuscitation</measure>
    <time_frame>within 10 mins of birth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>neonatal encephalopathy</measure>
    <time_frame>within 24 hours of birth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>serious neonatal morbidity or death</measure>
    <time_frame>within 28 days of birth</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">443</enrollment>
  <condition>Oxygen Inhalation Therapy</condition>
  <condition>Second Stage of Labour</condition>
  <condition>Fetal Distress</condition>
  <arm_group>
    <arm_group_label>air, second stage of labor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to the group will receive sham administered by nasal catheter.&#xD;
The therapy will continue until after delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxygen, 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 low flow nasal oxygen at a flow rate of 2 L/min.&#xD;
The therapy will continue until after delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low flow nasal oxygen</intervention_name>
    <description>Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery</description>
    <arm_group_label>oxygen, second stage of labor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low flow room air</intervention_name>
    <description>Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.</description>
    <arm_group_label>air, second stage of labor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at term&#xD;
&#xD;
          -  singleton&#xD;
&#xD;
          -  primigraida&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  spontaneous or induced labor&#xD;
&#xD;
          -  normal labor&#xD;
&#xD;
          -  normal FHR tracings in the first stage&#xD;
&#xD;
          -  at the onset of second stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  respiratory disease&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  diabetes mellitus or insulin-treated gestational diabetes mellitus&#xD;
&#xD;
          -  hypertension or preeclampsia&#xD;
&#xD;
          -  oligohydramnios&#xD;
&#xD;
          -  fetal growth restriction&#xD;
&#xD;
          -  placental abruption&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  disorders in oxygen saturations&#xD;
&#xD;
          -  received oxygen therapy in the first stage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 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>Navy General Hospital, Beijing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Navy General Hospital.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Navy General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Navy General Hospital.</name>
      <address>
        <city>Beijing</city>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.</citation>
    <PMID>28224745</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</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>Department of Obstetrics and Gynecology, Navy General Hospital, Beijing</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/NCT02221440
org study id: CYH001
nct id: NCT02221440
lead sponsor: 
has dmc: Yes
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.

      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second
      stage of labor can relieve fetal distress.
A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):

      Too little evidence to show whether oxygen administration to the woman during labour is
      beneficial to the baby.

      Some babies show signs of distress, such as unusual heart rates or the passing of a bowel
      motion (meconium) during their mother's labour. This may be caused by a lack of oxygen
      passing from the woman to the baby through the placenta. Sometimes, women may be encouraged
      to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen
      available to the unborn baby. A review of two trials found too little evidence to show
      whether oxygen administration to the woman during the second stage of labour is beneficial to
      the baby. No trials of oxygen administration when the baby is showing signs of distress were
      found. Further research is needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: cord arterial pH values (hydrogen ion concentration) less than 7.2
time frame: within 30-60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.
measure: Apgar score less than 7
time frame: at one and five 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 to form a backronym (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: maternal radial arterial partial pressure of oxygen
time frame: within 30-60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), radial artery blood gas sample will be obtained.
measure: umbilical cord venous partial pressure of oxygen
time frame: within 30-60 seconds of birth
description: Immediately after delivery (within 30-60 seconds of birth), umbilical cord venous blood gas sample will be obtained.
measure: cesarean delivery rate
time frame: during the second stage of labor
measure: assisted vaginal delivery
time frame: during the second stage of labor
measure: maternal dissatisfaction
time frame: during the second stage of labor
measure: abnormal fetal heart rate tracing
time frame: during the second stage of labor
measure: neonatal resuscitation
time frame: within 10 mins of birth
measure: neonatal encephalopathy
time frame: within 24 hours of birth
measure: serious neonatal morbidity or death
time frame: within 28 days of birth
arm group label: air, second stage of labor
arm group type: Placebo Comparator
description: Patients randomized to the group will receive sham administered by nasal catheter.
The therapy will continue until after delivery
arm group label: oxygen, second stage of labor
arm group type: Experimental
description: Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min.
The therapy will continue until after delivery
intervention type: Device
intervention name: Low flow nasal oxygen
description: Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery
arm group label: oxygen, second stage of labor
intervention type: Device
intervention name: Low flow room air
description: Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
arm group label: air, second stage of labor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yunhai Chuai, Dr
role: Principal Investigator
affiliation: Navy General Hospital, Beijing
facility: 
facility: 
facility: 
country: China
citation: Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.
PMID: 28224745
responsible party type: Principal Investigator
investigator affiliation: Navy General Hospital, Beijing
investigator full name: Yunhai Chuai
investigator title: Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
mesh term: Fetal Distress