<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/NCT03820505</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0442</org_study_id>
    <nct_id>NCT03820505</nct_id>
  </id_info>
  <brief_title>Observatory of Unintentional Births Hospital Extras</brief_title>
  <acronym>AIEH34</acronym>
  <official_title>Observatory of Unintentional Births Hospital Extras in Hérault</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SDIS34 - MONTPELLIER</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SAMU CHU Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      In France, pre-hospital unexpected birth is a rare situation, but over the last ten years,&#xD;
      the investigators have seen an increase in the number of these.&#xD;
&#xD;
      For this, the investigators realize an observatory of these deliveries and their care from&#xD;
      the call for help and the investigators continue the follow-up and the future of patients and&#xD;
      newborns until J7 postpartum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a result, the investigators also found a very high variability in the number of deliveries&#xD;
      per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per&#xD;
      month (May 2014 example).&#xD;
&#xD;
      Formalized expert recommendations were published in 2010 by SFAR, which then led to the&#xD;
      establishment of a national observatory for IEA at the end of 2011, in which the&#xD;
      investigators have been participating for 4 years.&#xD;
&#xD;
      Currently the national database lists 2000 unannounced deliveries including 230 in the&#xD;
      Hérault.&#xD;
&#xD;
      This observational study allows us to evaluate the management of these patients and newborns,&#xD;
      the risks and needs of pre-hospital teams, including the need for reinforcement and expertise&#xD;
      of midwives.&#xD;
&#xD;
      The investigators can also assess mortality and morbidity, as well as the extension of&#xD;
      hospital stays beyond J7&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of unexpected hospital deliveries (AIE)</measure>
    <time_frame>DAY 0 TO DAY 7 TO DELIVRERY</time_frame>
    <description>Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Method of taking care of unannounced extra hospital deliveries</measure>
    <time_frame>DAY 0 TO DAY 7 POST DELIVRERY</time_frame>
    <description>Method of taking care of unannounced extra hospital deliveries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties during an unexpected delivery outside maternity</measure>
    <time_frame>DAY 0 TO DAY 7 POST DELIVRERY</time_frame>
    <description>Identify the difficulties during an unexpected delivery outside maternity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risks during an unexpected delivery outside maternity</measure>
    <time_frame>DAY 0 TO DAY 7 POST DELIVRERY</time_frame>
    <description>Identify the risks during an unexpected delivery outside maternity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possible immediate complications during an unexpected delivery outside maternity</measure>
    <time_frame>DAY 0 TO DAY 7 POST DELIVRERY</time_frame>
    <description>Identify the possible immediate complications during an unexpected delivery outside maternity</description>
  </secondary_outcome>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Unexpected Delivery Outside Maternity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Unexpected delivery outside maternity in the Hérault department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unexpected delivery outside maternity, presence of a medical team during the care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of medicalization&#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>Christelle GRAF, wise woman</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christelle GRAF, wise woman</last_name>
    <phone>0677696194</phone>
    <phone_ext>33</phone_ext>
    <email>c-graf@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christelle GRAF, wise woman</last_name>
      <phone>0677696194</phone>
      <phone_ext>33</phone_ext>
      <email>c-graf@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obstetrics</keyword>
  <keyword>pre-hospital emergencies unannounced delivery outside maternity,</keyword>
  <keyword>mortality-morbidity</keyword>
  <keyword>reinforcement midwife in pre-hospital</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- 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/NCT03820505
org study id: RECHMPL18_0442
nct id: NCT03820505
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years,
      the investigators have seen an increase in the number of these.

      For this, the investigators realize an observatory of these deliveries and their care from
      the call for help and the investigators continue the follow-up and the future of patients and
      newborns until J7 postpartum.
As a result, the investigators also found a very high variability in the number of deliveries
      per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per
      month (May 2014 example).

      Formalized expert recommendations were published in 2010 by SFAR, which then led to the
      establishment of a national observatory for IEA at the end of 2011, in which the
      investigators have been participating for 4 years.

      Currently the national database lists 2000 unannounced deliveries including 230 in the
      Hérault.

      This observational study allows us to evaluate the management of these patients and newborns,
      the risks and needs of pre-hospital teams, including the need for reinforcement and expertise
      of midwives.

      The investigators can also assess mortality and morbidity, as well as the extension of
      hospital stays beyond J7
observational model: Cohort
time perspective: Prospective
measure: number of unexpected hospital deliveries (AIE)
time frame: DAY 0 TO DAY 7 TO DELIVRERY
description: Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity
measure: Method of taking care of unannounced extra hospital deliveries
time frame: DAY 0 TO DAY 7 POST DELIVRERY
description: Method of taking care of unannounced extra hospital deliveries
measure: Difficulties during an unexpected delivery outside maternity
time frame: DAY 0 TO DAY 7 POST DELIVRERY
description: Identify the difficulties during an unexpected delivery outside maternity
measure: Risks during an unexpected delivery outside maternity
time frame: DAY 0 TO DAY 7 POST DELIVRERY
description: Identify the risks during an unexpected delivery outside maternity
measure: Possible immediate complications during an unexpected delivery outside maternity
time frame: DAY 0 TO DAY 7 POST DELIVRERY
description: Identify the possible immediate complications during an unexpected delivery outside maternity
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: Christelle GRAF, wise woman
role: Principal Investigator
affiliation: University Hospital, Montpellier
last name: Christelle GRAF, wise woman
phone: 0677696194
phone ext: 33
email: c-graf@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC