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/NCT06036277</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN702023/CHUSTE</org_study_id>
      <nct_id>NCT06036277</nct_id>
    </id_info>
    <brief_title>Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women</brief_title>
    <official_title>Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women in Case of a Desire for Physiological Delivery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</source>
    <oversight_info>
      <has_dmc>No</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>
        Women are showing a growing interest in less medicalized childbirth. According to the french&#xD;
        2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women&#xD;
        want childbirth without epidural anesthesia. Between 77 and 82% of deliveries nevertheless&#xD;
        lead to an epidural anesthesia. The painful feeling seems to be the main motivation for using&#xD;
        this mode of anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the scientific literature, few data from clinical studies focus on the effects of&#xD;
        immersion in water during childbirth. The analgesic effects of immersion in water to lessen&#xD;
        the painful experience are yet to be proven. The opening of a physiological delivery room&#xD;
        with a bathtub at the Saint-Etienne University Hospital since October 2020 provides data that&#xD;
        has not been exploited yet and could make possible to answer the question of the analgesic&#xD;
        effects of immersion in water during labour. The difficulties of analysis and the&#xD;
        subjectivity of the painful feeling led us to consider the request of epidural anesthesia as&#xD;
        the main analysis criterion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of requests for epidural anesthesia by parturients</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of the first stage of childbirth</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of the second stage of childbirth</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of the third stage of childbirth</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of instrumental extractions</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of caesareans</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and degree of perineal tear</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of episiotomy by the obstetrical team</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.&#xD;
  At 5 minutes a score of 7 to 10 is considered normal; a score of 4 to 6 is intermediate and a score of 0 to 3 is low.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial pH measured at the umbilical cord</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonatal resuscitation</measure>
      <time_frame>Day 0</time_frame>
      <description>Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">249</enrollment>
    <condition>Delivery</condition>
    <condition>Labor Pain</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <description>Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>General data</intervention_name>
      <description>General data will be collected to ensure that both groups are comparable : maternal age, maternal BMI, gestational age, parity, number of children in current pregnancy, history of caesarian section, newborn child weight</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Other data</intervention_name>
      <description>Other data collected will be used to estimate primary and secondary outcomes : request for an epidural anesthesia by the parturient, medical indication for peridural anesthesia, duration of childbirth, delivery methods, occurrence of maternal or neonatal complications.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnent women who used the physiological delivery room of the Saint-Etienne University&#xD;
          Hospital between October 2020 and December 2022.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All women who used the physiological delivery room of the Saint-Etienne University&#xD;
               Hospital between October 2020 and December 2022.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Absence of physiological desire for childbirth.&#xD;
  &#xD;
            -  Medical indication for epidural anesthesia.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tiphaine BARJAT, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint Etienne</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Saint Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <zip>42000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Water immersion</keyword>
    <keyword>Waterbirth</keyword>
    <keyword>Childbirth</keyword>
    <keyword>Labor pain</keyword>
    <keyword>Epidural anesthesia</keyword>
    <keyword>Physiological delivery</keyword>
    <keyword>Pregnant women</keyword>
    <keyword>General medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Labor Pain</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/NCT06036277
  org study id: IRBN702023/CHUSTE
  nct id: NCT06036277
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Women are showing a growing interest in less medicalized childbirth. According to the french
        2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women
        want childbirth without epidural anesthesia. Between 77 and 82% of deliveries nevertheless
        lead to an epidural anesthesia. The painful feeling seems to be the main motivation for using
        this mode of anesthesia.
  In the scientific literature, few data from clinical studies focus on the effects of
        immersion in water during childbirth. The analgesic effects of immersion in water to lessen
        the painful experience are yet to be proven. The opening of a physiological delivery room
        with a bathtub at the Saint-Etienne University Hospital since October 2020 provides data that
        has not been exploited yet and could make possible to answer the question of the analgesic
        effects of immersion in water during labour. The difficulties of analysis and the
        subjectivity of the painful feeling led us to consider the request of epidural anesthesia as
        the main analysis criterion.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Number of requests for epidural anesthesia by parturients
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Duration of the first stage of childbirth
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Duration of the second stage of childbirth
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Duration of the third stage of childbirth
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Number of instrumental extractions
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Number of caesareans
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Number and degree of perineal tear
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Use of episiotomy by the obstetrical team
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Estimated postpartum hemorrhagic volume and occurrence of postpartum hemorrhage
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Apgar score (Appearance, Pulse, Grimace, Activity, Respiration) from 0 to 10 of the child at birth
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  At 5 minutes a score of 7 to 10 is considered normal; a score of 4 to 6 is intermediate and a score of 0 to 3 is low.
  measure: Arterial pH measured at the umbilical cord
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  measure: Number of neonatal resuscitation
  time frame: Day 0
  description: Retrospective collection of medical data from the computer software Easily in Saint-Etienne university hospital center.
  arm group label: Experimental group
  description: Women who wish to give birth without epidural anesthesia and have benefited of water immersion during labor
  arm group label: Control group
  description: Women who wish to give birth without epidural anesthesia and have not benefited of water immersion during labor
  intervention type: Other
  intervention name: General data
  description: General data will be collected to ensure that both groups are comparable : maternal age, maternal BMI, gestational age, parity, number of children in current pregnancy, history of caesarian section, newborn child weight
  arm group label: Control group
  arm group label: Experimental group
  intervention type: Other
  intervention name: Other data
  description: Other data collected will be used to estimate primary and secondary outcomes : request for an epidural anesthesia by the parturient, medical indication for peridural anesthesia, duration of childbirth, delivery methods, occurrence of maternal or neonatal complications.
  arm group label: Control group
  arm group label: Experimental group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tiphaine BARJAT, MD PhD
  role: Principal Investigator
  affiliation: CHU Saint Etienne
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Labor Pain
  sharing ipd: No