xml: <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/NCT06036797</url>
    </required_header>
    <id_info>
      <org_study_id>MCHH_003</org_study_id>
      <nct_id>NCT06036797</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia</brief_title>
    <official_title>Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maternal and Child Health Hospital of Hubei Province</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maternal and Child Health Hospital of Hubei Province</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>
        The purpose of this study is to compare the effects of three different doses of hydromorphone&#xD;
        combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor&#xD;
        analgesia through prospective clinical trials, so as to explore whether hydromorphone&#xD;
        combined with ropivacaine has advantages in epidural labor analgesia, and find out the&#xD;
        optimal dose of hydromorphone.&#xD;
  &#xD;
        Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group&#xD;
        4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08%&#xD;
        ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered&#xD;
        with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in&#xD;
        Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for&#xD;
        epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml&#xD;
        sufentanil and 0.08% ropivacaine for epidural labor analgesia.&#xD;
  &#xD;
        The goal of this clinical trial is to provide a new treatment option for pregnant women in&#xD;
        epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine&#xD;
        in epidural labor analgesia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 17, 2023</start_date>
    <completion_date type="Anticipated">October 17, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 17, 2023</primary_completion_date>
    <phase>Phase 2</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale(VAS)</measure>
      <time_frame>30 minutes-1 hour</time_frame>
      <description>VAS will be monitored and recorded at 6 time points, including the time of entering the operating room(Time 0), when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), when the first dose is given for 30 minutes(Time 3), 30 minutes after delivery (Time 4), and 60 minutes after delivery (Time 5). The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate(HR)</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>HR will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean arterial pressure(MAP)</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>MAP will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulse oxygen saturation</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>Pulse oxygen saturation will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of analgesia</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>Defined as the time from labor analgesia to delivery of the fetus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of compressions</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>30 minutes-1.5 hours</time_frame>
      <description>The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Apgar scores</measure>
      <time_frame>1 minute and 5 minutes after birth</time_frame>
      <description>The Apgar scores of 1 minute and 5 minutes after birth will be recorded.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Analgesia</condition>
    <condition>Labor Pain</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hydromorphone</intervention_name>
      <description>For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sufentanil</intervention_name>
      <description>For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil</description>
      <arm_group_label>Group 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine</intervention_name>
      <description>0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>Group 4</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status II&#xD;
  &#xD;
            -  a single fetus&#xD;
  &#xD;
            -  competent to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe respiratory diseases including hypoxemia, respiratory failure and severe&#xD;
               pneumonia&#xD;
  &#xD;
            -  severe circulatory diseases including acute decompensated heart failure and peripartum&#xD;
               cardiomyopathy&#xD;
  &#xD;
            -  placenta previa&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Na Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maternal and Child Health Hospital of Hubei Province</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Na Li, MD</last_name>
      <phone>+862763490107</phone>
      <email>lina@hbfy.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Maternal and Child Health Hospital of Hubei Province</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Maternal and Child Health Hospital of Hubei Province</investigator_affiliation>
      <investigator_full_name>Li Na</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Labor Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sufentanil</mesh_term>
      <mesh_term>Hydromorphone</mesh_term>
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036797
  org study id: MCHH_003
  nct id: NCT06036797
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare the effects of three different doses of hydromorphone
        combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor
        analgesia through prospective clinical trials, so as to explore whether hydromorphone
        combined with ropivacaine has advantages in epidural labor analgesia, and find out the
        optimal dose of hydromorphone.
  
        Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group
        4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08%
        ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered
        with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in
        Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for
        epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml
        sufentanil and 0.08% ropivacaine for epidural labor analgesia.
  
        The goal of this clinical trial is to provide a new treatment option for pregnant women in
        epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine
        in epidural labor analgesia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Visual Analogue Scale(VAS)
  time frame: 30 minutes-1 hour
  description: VAS will be monitored and recorded at 6 time points, including the time of entering the operating room(Time 0), when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), when the first dose is given for 30 minutes(Time 3), 30 minutes after delivery (Time 4), and 60 minutes after delivery (Time 5). The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
  measure: Heart rate(HR)
  time frame: 30 minutes-1.5 hours
  description: HR will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).
  measure: Mean arterial pressure(MAP)
  time frame: 30 minutes-1.5 hours
  description: MAP will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).
  measure: Pulse oxygen saturation
  time frame: 30 minutes-1.5 hours
  description: Pulse oxygen saturation will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).
  measure: Duration of analgesia
  time frame: 30 minutes-1.5 hours
  description: Defined as the time from labor analgesia to delivery of the fetus.
  measure: The number of compressions
  time frame: 30 minutes-1.5 hours
  description: The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.
  measure: Adverse reactions
  time frame: 30 minutes-1.5 hours
  description: The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).
  measure: The Apgar scores
  time frame: 1 minute and 5 minutes after birth
  description: The Apgar scores of 1 minute and 5 minutes after birth will be recorded.
  arm group label: Group 1
  arm group type: Experimental
  description: Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
  arm group label: Group 2
  arm group type: Experimental
  description: Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
  arm group label: Group 3
  arm group type: Experimental
  description: Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
  arm group label: Group 4
  arm group type: Active Comparator
  description: Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
  intervention type: Drug
  intervention name: Hydromorphone
  description: For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  intervention type: Drug
  intervention name: Sufentanil
  description: For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil
  arm group label: Group 4
  intervention type: Drug
  intervention name: Ropivacaine
  description: 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  arm group label: Group 4
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Na Li, MD
  role: Principal Investigator
  affiliation: Maternal and Child Health Hospital of Hubei Province
  last name: Na Li, MD
  phone: +862763490107
  email: lina@hbfy.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Maternal and Child Health Hospital of Hubei Province
  investigator full name: Li Na
  investigator title: Deputy Chief Physician
  mesh term: Labor Pain
  mesh term: Sufentanil
  mesh term: Hydromorphone
  mesh term: Ropivacaine