<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/NCT03305601</url>
  </required_header>
  <id_info>
    <org_study_id>SMARTMATER</org_study_id>
    <nct_id>NCT03305601</nct_id>
  </id_info>
  <brief_title>Information During Maternity</brief_title>
  <official_title>Information During Maternity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the&#xD;
      couple about the medical, non medical informations and explain the physiological changes . As&#xD;
      usual, medical staff and doctors explain and inform by oral and with a booklet patient.&#xD;
&#xD;
      In order to cluster and make more accessible these informations, the maternity team of GHPSJ&#xD;
      has developed an application on smartphone . If this application has been evaluated on his&#xD;
      contents and accordance to recommendations, there is no evaluation about the satisfaction of&#xD;
      patient.&#xD;
&#xD;
      The aim is to study the impact of this kind of application on pregnant women satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>satisfaction score</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">104</enrollment>
  <condition>Pregnancy Related</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>application on smarthphone</intervention_name>
    <description>application on smarthphone</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single pregnancy&#xD;
&#xD;
          -  delivery at 37 weeks of amenhorrhea&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
          -  with an email address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing participation&#xD;
&#xD;
          -  foetal pathology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</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/NCT03305601
org study id: SMARTMATER
nct id: NCT03305601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the
      couple about the medical, non medical informations and explain the physiological changes . As
      usual, medical staff and doctors explain and inform by oral and with a booklet patient.

      In order to cluster and make more accessible these informations, the maternity team of GHPSJ
      has developed an application on smartphone . If this application has been evaluated on his
      contents and accordance to recommendations, there is no evaluation about the satisfaction of
      patient.

      The aim is to study the impact of this kind of application on pregnant women satisfaction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: satisfaction score
time frame: 9 months
intervention type: Other
intervention name: application on smarthphone
description: application on smarthphone
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor