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/NCT05990504</url>
    </required_header>
    <id_info>
      <org_study_id>Dural Puncture Epidural</org_study_id>
      <nct_id>NCT05990504</nct_id>
    </id_info>
    <brief_title>The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia</brief_title>
    <acronym>DPE</acronym>
    <official_title>The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zongxun Lin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Provincial Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely&#xD;
        used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And&#xD;
        Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance&#xD;
        technology. This technology ensures the accuracy of intervertebral space positioning and&#xD;
        puncture success rate through operational visualization, and reduces the impact of operator&#xD;
        proficiency on research results.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely&#xD;
        used in Maternal. The implementation step is to complete the epidural puncture, temporarily&#xD;
        do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do&#xD;
        not directly inject drugs into the subarachnoid space, and then leave an epidural catheter&#xD;
        for administration according to epidural block. The theoretical basis is that anesthetic&#xD;
        drugs can originally penetrate into the subarachnoid space from the epidural space through a&#xD;
        complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this&#xD;
        process.After injecting high volume anesthetic drugs into the epidural space, the pressure&#xD;
        increases, and the drug penetrates from the epidural space through the puncture hole along a&#xD;
        pressure gradient to the subarachnoid space, thereby enhancing the effect of labor&#xD;
        analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural&#xD;
        needle is in the middle of the epidural space again, thereby reducing the incidence of&#xD;
        epidural catheter insertion failure or deviation to one side.This study combines ultrasound&#xD;
        real-time guidance technology. This technology ensures the accuracy of intervertebral space&#xD;
        positioning and puncture success rate through operational visualization, and reduces the&#xD;
        impact of operator proficiency on research results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Analgesic effect（onset time）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Analgesic effect of pregnant women（onset time）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analgesic effect（block level）</measure>
      <time_frame>7 weeks</time_frame>
      <description>block level of pregnant women by Alcohol swab（temperature sensation：Pubic symphysis=T12，umbilical region=T10，hypochondrium=T8，xiphoid process=T6，Nipple connection=T4，subclavian=T2）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analgesic effect（block effect）</measure>
      <time_frame>7 weeks</time_frame>
      <description>block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analgesic effect（Visual Analogue Scale）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Analgesic effect of pregnant women by Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analgesic effect（Patient controlled analgesia）</measure>
      <time_frame>7 weeks</time_frame>
      <description>number and time of Patient controlled analgesia（Press the PCA button when the patient feels pain）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uterine contraction indicators（Frequency）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess uterine contractions（Frequency）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uterine contraction indicators（duration）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess uterine contractions（duration）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uterine contraction indicators（Number of pregnant women with Tachysystole）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Tachysystole=More than 5 Uterine contraction in 10 minutes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uterine contraction indicators（Number of pregnant women with hypertonus）</measure>
      <time_frame>7 weeks</time_frame>
      <description>hypertonus=Each Uterine contraction lasts for more than 2 minutes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fetal heart indicators（Fetal heart rate）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess fetal heart（Fetal heart rate）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fetal heart indicators（NICHD classification）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess fetal heart（NICHD classification）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fetal heart indicators（Fetal Heart Rate decelerations）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess fetal heart（Fetal Heart Rate decelerations）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fetal heart indicators（Fetal Heart Rate Variability）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assess fetal heart（Fetal Heart Rate Variability）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Apgar score</measure>
      <time_frame>7 weeks</time_frame>
      <description>Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sacral sensory block of pregnant women</measure>
      <time_frame>7 weeks</time_frame>
      <description>Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block））</description>
    </primary_outcome>
    <primary_outcome>
      <measure>modified bromage score</measure>
      <time_frame>7 weeks</time_frame>
      <description>modified bromage score（scale title=modified bromage score，Total score=0-3，0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked)）</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Operation evaluation（Time）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assessment of puncture condition（Time）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Operation evaluation（number of times）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assessment of puncture condition（number of times）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Operation evaluation（side effects and Complications）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Assessment of puncture condition（side effects and Complications）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delivery mode</measure>
      <time_frame>7 weeks</time_frame>
      <description>natural labor/cesarean section/instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of Interleukin 6</measure>
      <time_frame>7 weeks</time_frame>
      <description>Pregnant women's venous blood Interleukin 6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of hypersensitive C-reactive protein</measure>
      <time_frame>7 weeks</time_frame>
      <description>Pregnant women's venous blood hypersensitive C-reactive protein</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of cortisol</measure>
      <time_frame>7 weeks</time_frame>
      <description>Pregnant women's venous blood cortisol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal rehabilitation indicators（Postpartum hospital stay）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Postpartum hospitalization days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））</measure>
      <time_frame>7 weeks</time_frame>
      <description>Postoperative Recovery Quality Scale（QOR-40）（scale title=Postoperative Recovery Quality Scale（QOR-40），Total score=0-200，The higher the score the better the recovery）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of pregnant women with adjust the treatment plan and adjustment method</measure>
      <time_frame>7 weeks</time_frame>
      <description>adjustment method include Adjust the Epidural catheter or Adjusting drug dosage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug consumption</measure>
      <time_frame>7 weeks</time_frame>
      <description>Drug consumption</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of stages of labor（time）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Effect of stages of labor（time）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>body temperature changes</measure>
      <time_frame>7 weeks</time_frame>
      <description>body temperature changes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of pregnant women with Infection during labor</measure>
      <time_frame>7 weeks</time_frame>
      <description>whether Infection during labor of pregnant women</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side effects and complications of labor analgesia</measure>
      <time_frame>7 weeks</time_frame>
      <description>Side effects and complications of labor analgesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of pregnant women and reason with conversion of natural labor to Caesarean section</measure>
      <time_frame>7 weeks</time_frame>
      <description>Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Rating Anxiety Scale</measure>
      <time_frame>7 weeks</time_frame>
      <description>Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delivery fear score（numerical rating scale）</measure>
      <time_frame>7 weeks</time_frame>
      <description>Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delivery satisfaction survey</measure>
      <time_frame>7 weeks</time_frame>
      <description>Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Labor Analgesia</condition>
    <arm_group>
      <arm_group_label>Dural Puncture Epidural Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dural Puncture Epidural is a new type of labor analgesia technology.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Epidural Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Epidural is a traditional labor analgesia technique.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia</intervention_name>
      <description>Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.</description>
      <arm_group_label>Dural Puncture Epidural Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ultrasound real-time guidance combined with Epidural Labor Anagesia</intervention_name>
      <description>Epidural is a traditional labor analgesia technique.</description>
      <arm_group_label>Epidural Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. American Society of Anesthesiologists (ASA) Class I or II;&#xD;
  &#xD;
            2. Single healthy pregnancy;&#xD;
  &#xD;
            3. Head showing first;&#xD;
  &#xD;
            4. 37 to 41 weeks;&#xD;
  &#xD;
            5. The labor process is active, and the cervix dilates&lt;5cm;&#xD;
  &#xD;
            6. Require epidural labor analgesia;&#xD;
  &#xD;
            7. Volunteer to participate in this study and sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia,&#xD;
               pregnancy diabetes;&#xD;
  &#xD;
            2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2)&#xD;
               Infection or septicemia at the puncture site. 3) Coagulation dysfunction;&#xD;
  &#xD;
            3. Known cases of fetal malformation or increased risk of cesarean section, such as a&#xD;
               history of uterine rupture;&#xD;
  &#xD;
            4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot&#xD;
               cooperate.&#xD;
  &#xD;
            5. Patients with long-term use of opioids, steroids, and chronic pain.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zongxun Lin, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Provincial Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zongxun Lin, Master</last_name>
      <phone>+8613763820916</phone>
      <email>13763820916@189.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fujian Provincial Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zongxun Lin, Master</last_name>
        <phone>+8613763820916</phone>
        <email>13763820916@189.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
      <investigator_full_name>Zongxun Lin</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>labor analgesia</keyword>
    <keyword>delivery woman</keyword>
    <keyword>neonate</keyword>
    <keyword>Effectiveness</keyword>
    <keyword>Safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05990504
  org study id: Dural Puncture Epidural
  nct id: NCT05990504
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely
        used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And
        Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance
        technology. This technology ensures the accuracy of intervertebral space positioning and
        puncture success rate through operational visualization, and reduces the impact of operator
        proficiency on research results.
  Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely
        used in Maternal. The implementation step is to complete the epidural puncture, temporarily
        do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do
        not directly inject drugs into the subarachnoid space, and then leave an epidural catheter
        for administration according to epidural block. The theoretical basis is that anesthetic
        drugs can originally penetrate into the subarachnoid space from the epidural space through a
        complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this
        process.After injecting high volume anesthetic drugs into the epidural space, the pressure
        increases, and the drug penetrates from the epidural space through the puncture hole along a
        pressure gradient to the subarachnoid space, thereby enhancing the effect of labor
        analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural
        needle is in the middle of the epidural space again, thereby reducing the incidence of
        epidural catheter insertion failure or deviation to one side.This study combines ultrasound
        real-time guidance technology. This technology ensures the accuracy of intervertebral space
        positioning and puncture success rate through operational visualization, and reduces the
        impact of operator proficiency on research results.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Analgesic effect（onset time）
  time frame: 7 weeks
  description: Analgesic effect of pregnant women（onset time）
  measure: Analgesic effect（block level）
  time frame: 7 weeks
  description: block level of pregnant women by Alcohol swab（temperature sensation：Pubic symphysis=T12，umbilical region=T10，hypochondrium=T8，xiphoid process=T6，Nipple connection=T4，subclavian=T2）
  measure: Analgesic effect（block effect）
  time frame: 7 weeks
  description: block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
  measure: Analgesic effect（Visual Analogue Scale）
  time frame: 7 weeks
  description: Analgesic effect of pregnant women by Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）
  measure: Analgesic effect（Patient controlled analgesia）
  time frame: 7 weeks
  description: number and time of Patient controlled analgesia（Press the PCA button when the patient feels pain）
  measure: Uterine contraction indicators（Frequency）
  time frame: 7 weeks
  description: Assess uterine contractions（Frequency）
  measure: Uterine contraction indicators（duration）
  time frame: 7 weeks
  description: Assess uterine contractions（duration）
  measure: Uterine contraction indicators（Number of pregnant women with Tachysystole）
  time frame: 7 weeks
  description: Tachysystole=More than 5 Uterine contraction in 10 minutes
  measure: Uterine contraction indicators（Number of pregnant women with hypertonus）
  time frame: 7 weeks
  description: hypertonus=Each Uterine contraction lasts for more than 2 minutes
  measure: Fetal heart indicators（Fetal heart rate）
  time frame: 7 weeks
  description: Assess fetal heart（Fetal heart rate）
  measure: Fetal heart indicators（NICHD classification）
  time frame: 7 weeks
  description: Assess fetal heart（NICHD classification）
  measure: Fetal heart indicators（Fetal Heart Rate decelerations）
  time frame: 7 weeks
  description: Assess fetal heart（Fetal Heart Rate decelerations）
  measure: Fetal heart indicators（Fetal Heart Rate Variability）
  time frame: 7 weeks
  description: Assess fetal heart（Fetal Heart Rate Variability）
  measure: Apgar score
  time frame: 7 weeks
  description: Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）
  measure: Sacral sensory block of pregnant women
  time frame: 7 weeks
  description: Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block））
  measure: modified bromage score
  time frame: 7 weeks
  description: modified bromage score（scale title=modified bromage score，Total score=0-3，0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked)）
  measure: Operation evaluation（Time）
  time frame: 7 weeks
  description: Assessment of puncture condition（Time）
  measure: Operation evaluation（number of times）
  time frame: 7 weeks
  description: Assessment of puncture condition（number of times）
  measure: Operation evaluation（side effects and Complications）
  time frame: 7 weeks
  description: Assessment of puncture condition（side effects and Complications）
  measure: Delivery mode
  time frame: 7 weeks
  description: natural labor/cesarean section/instrument
  measure: Concentration of Interleukin 6
  time frame: 7 weeks
  description: Pregnant women's venous blood Interleukin 6
  measure: Concentration of hypersensitive C-reactive protein
  time frame: 7 weeks
  description: Pregnant women's venous blood hypersensitive C-reactive protein
  measure: Concentration of cortisol
  time frame: 7 weeks
  description: Pregnant women's venous blood cortisol
  measure: Maternal rehabilitation indicators（Postpartum hospital stay）
  time frame: 7 weeks
  description: Postpartum hospitalization days
  measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）
  time frame: 7 weeks
  description: Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）
  measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））
  time frame: 7 weeks
  description: Postoperative Recovery Quality Scale（QOR-40）（scale title=Postoperative Recovery Quality Scale（QOR-40），Total score=0-200，The higher the score the better the recovery）
  measure: Number of pregnant women with adjust the treatment plan and adjustment method
  time frame: 7 weeks
  description: adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
  measure: Drug consumption
  time frame: 7 weeks
  description: Drug consumption
  measure: Effect of stages of labor（time）
  time frame: 7 weeks
  description: Effect of stages of labor（time）
  measure: body temperature changes
  time frame: 7 weeks
  description: body temperature changes
  measure: Number of pregnant women with Infection during labor
  time frame: 7 weeks
  description: whether Infection during labor of pregnant women
  measure: Side effects and complications of labor analgesia
  time frame: 7 weeks
  description: Side effects and complications of labor analgesia
  measure: Number of pregnant women and reason with conversion of natural labor to Caesarean section
  time frame: 7 weeks
  description: Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
  measure: Self-Rating Anxiety Scale
  time frame: 7 weeks
  description: Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）
  measure: Delivery fear score（numerical rating scale）
  time frame: 7 weeks
  description: Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）
  measure: Delivery satisfaction survey
  time frame: 7 weeks
  description: Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)
  arm group label: Dural Puncture Epidural Group
  arm group type: Experimental
  description: Dural Puncture Epidural is a new type of labor analgesia technology.
  arm group label: Epidural Group
  arm group type: Active Comparator
  description: Epidural is a traditional labor analgesia technique.
  intervention type: Device
  intervention name: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia
  description: Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.
  arm group label: Dural Puncture Epidural Group
  intervention type: Device
  intervention name: ultrasound real-time guidance combined with Epidural Labor Anagesia
  description: Epidural is a traditional labor analgesia technique.
  arm group label: Epidural Group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Zongxun Lin, Master
  role: Principal Investigator
  affiliation: Fujian Provincial Hospital
  last name: Zongxun Lin, Master
  phone: +8613763820916
  email: 13763820916@189.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fujian Provincial Hospital
  investigator full name: Zongxun Lin
  investigator title: Principal Investigator
  mesh term: Agnosia
  sharing ipd: No