<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/NCT03815227</url>
  </required_header>
  <id_info>
    <org_study_id>2016-06-CHRMT</org_study_id>
    <nct_id>NCT03815227</nct_id>
  </id_info>
  <brief_title>Outpatient Birth: Pilot Study</brief_title>
  <acronym>ACCAMBU</acronym>
  <official_title>Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</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>
      The diminution of the average length stay (ALS) in French maternity is a clear evolution, the&#xD;
      objective of the draft law on social security is to reduce the ALS to equal other OECD&#xD;
      countries. The over-medicalization of maternal health raises the question of relevant and&#xD;
      iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed&#xD;
      their wish for an individual support and more physiological respectful. A more-effective&#xD;
      Professional coordination is expected where the midwife is a major player.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to identify and evaluate an outpatient birth path during the first 24&#xD;
      hours after the birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Output rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Output rate within 24 hours of birth</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Outpatient Birth</condition>
  <arm_group>
    <arm_group_label>Outpatient birth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maternity out the same date or the next day of the birth</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Outpatient birth</intervention_name>
    <description>Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife</description>
    <arm_group_label>Outpatient birth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With no multiple pregnancy, of less than 20 weeks of gestation&#xD;
&#xD;
          -  With a BMI between 17,5 and 35 kg/m²&#xD;
&#xD;
          -  is able to understand research's informations&#xD;
&#xD;
          -  affiliated member of the social security system&#xD;
&#xD;
          -  Have given an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With psychological vulnerability, social vulnerability, addictions and high dependency&#xD;
&#xD;
          -  With an unbalanced chronic pathology or susceptible to contraindicated a physiologic&#xD;
             birth&#xD;
&#xD;
          -  With history of caesarean, foeto-maternal incompatibility, gestational hypertension,&#xD;
             pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear&#xD;
&#xD;
          -  With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal&#xD;
             death&#xD;
&#xD;
          -  With history of puerperal psychosis&#xD;
&#xD;
          -  Under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant woman</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHR Metz Thionville</name>
      <address>
        <city>Thionville</city>
        <state>Moselle</state>
        <zip>57100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03815227
org study id: 2016-06-CHRMT
nct id: NCT03815227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The diminution of the average length stay (ALS) in French maternity is a clear evolution, the
      objective of the draft law on social security is to reduce the ALS to equal other OECD
      countries. The over-medicalization of maternal health raises the question of relevant and
      iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed
      their wish for an individual support and more physiological respectful. A more-effective
      Professional coordination is expected where the midwife is a major player.
The aim of the study is to identify and evaluate an outpatient birth path during the first 24
      hours after the birth.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Output rate
time frame: Day 1
description: Output rate within 24 hours of birth
arm group label: Outpatient birth
arm group type: Experimental
description: Maternity out the same date or the next day of the birth
intervention type: Other
intervention name: Outpatient birth
description: Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife
arm group label: Outpatient birth
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant woman
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor