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/NCT06012591</url>
    </required_header>
    <id_info>
      <org_study_id>RC 16/22</org_study_id>
      <nct_id>NCT06012591</nct_id>
    </id_info>
    <brief_title>Implementation of WHO Standards for Improving Maternal and Newborn Care</brief_title>
    <acronym>IMAgiNE</acronym>
    <official_title>Implementation of WHO Standards for Improving the Quality of Maternal-neonatal Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS Burlo Garofolo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS Burlo Garofolo</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>
        High-quality respectful care around the time of childbirth is a fundamental aspect of human&#xD;
        rights and, according to recent global estimates, could prevent more than 100,000 maternal&#xD;
        deaths and 1.3 million neonatal deaths annually. Despite some maternal and newborn health&#xD;
        indicators in high-income countries being better in comparison to low-income and&#xD;
        middle-income countries, existing evidence shows that improvements are needed in the quality&#xD;
        of care provided to women and newborns in every country.&#xD;
  &#xD;
        In 2016, the World Health Organization (WHO) developed a framework and a list of Standards&#xD;
        for improving the quality of maternal and newborn care (QMNC). The WHO Standards define a set&#xD;
        of 318 Quality Measures, divided into three key domains - experience of care, provision of&#xD;
        care and availability of resources - which can be used to assess the QMNC at facility level.&#xD;
        The ongoing project, named IMAgiNE (Improving MAternal Newborn carE), includes all&#xD;
        maternities hospitals of the FVG Region and aimed at improving the quality of maternal and&#xD;
        neonatal health care in the region. Quality of care is assessed using two complementary&#xD;
        perspectives (women and health workers), with two validated questionnaires including about&#xD;
        100 quality measures based on the WHO Standards. It provides data on both the baseline&#xD;
        assessment and the Quality Improvement component (progresses made).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2019</start_date>
    <completion_date type="Anticipated">January 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2026</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>
      <intervention_model_description>Before-after study</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Maternal and Newborn Care Index evaluated by women</measure>
      <time_frame>At hospital discharge (assessed up to day 5)</time_frame>
      <description>Evaluated by questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Maternal and Newborn Care Index evaluated by health professionals</measure>
      <time_frame>At hospital discharge (assessed up to day 5)</time_frame>
      <description>Evaluated by questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of caesarean section</measure>
      <time_frame>At hospital discharge (assessed up to day 5)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of episiotomy</measure>
      <time_frame>At hospital discharge (assessed up to day 5)</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">9000</enrollment>
    <condition>Perinatal Care</condition>
    <arm_group>
      <arm_group_label>WHO Standard implementation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality improvement recommendations (action plans)</intervention_name>
      <description>Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment</description>
      <arm_group_label>WHO Standard implementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For women:&#xD;
  &#xD;
          1. Women who give birth at the nine maternity hospitals of the Friuli Venezia Giulia (FVG)&#xD;
          Region, Italy&#xD;
  &#xD;
          For health workers&#xD;
  &#xD;
          1. All health workers directly involved in maternal/neonatal care at facility level in the&#xD;
          FVG Region (i.e. general physicians currently working in maternal or neonatal care,&#xD;
          midwives, nurses, neonatologists, obstetrics and gynecology doctors, and medical residents&#xD;
          )&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For women:&#xD;
  &#xD;
            1. Age &lt;18 years;&#xD;
  &#xD;
            2. Stillbirth or neonatal death;&#xD;
  &#xD;
            3. Psychiatric problems who may interfere with the telephone interview;&#xD;
  &#xD;
            4. Hidden pregnancy or women whose child has been adopted or placed in foster care;&#xD;
  &#xD;
            5. Refusal to participate.&#xD;
  &#xD;
          For health workers&#xD;
  &#xD;
            1. Refusal to participate;&#xD;
  &#xD;
            2. Prolonged absence with unavailability during the study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marzia Lazzerini, MD</last_name>
      <role>Study Director</role>
      <affiliation>IRCCS materno infantile Burlo Garofolo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marzia Lazzerini, MD</last_name>
      <phone>+390403785555</phone>
      <email>marzia.lazzerini@burlo.trieste.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emanuelle Pessa Valente, MD</last_name>
      <email>emanuelle.pessavalente@burlo.trieste.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>IRCCS Burlo Garofolo</name>
        <address>
          <city>Trieste</city>
          <zip>34137</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marzia Lazzerini, MD</last_name>
        <phone>+390403785555</phone>
        <email>marzia.lazzerini@burlo.trieste.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>maternal and newborn care</keyword>
    <keyword>quality of care</keyword>
    <keyword>quality improvement</keyword>
    <keyword>WHO standards</keyword>
    <!-- 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/NCT06012591
  org study id: RC 16/22
  nct id: NCT06012591
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  High-quality respectful care around the time of childbirth is a fundamental aspect of human
        rights and, according to recent global estimates, could prevent more than 100,000 maternal
        deaths and 1.3 million neonatal deaths annually. Despite some maternal and newborn health
        indicators in high-income countries being better in comparison to low-income and
        middle-income countries, existing evidence shows that improvements are needed in the quality
        of care provided to women and newborns in every country.
  
        In 2016, the World Health Organization (WHO) developed a framework and a list of Standards
        for improving the quality of maternal and newborn care (QMNC). The WHO Standards define a set
        of 318 Quality Measures, divided into three key domains - experience of care, provision of
        care and availability of resources - which can be used to assess the QMNC at facility level.
        The ongoing project, named IMAgiNE (Improving MAternal Newborn carE), includes all
        maternities hospitals of the FVG Region and aimed at improving the quality of maternal and
        neonatal health care in the region. Quality of care is assessed using two complementary
        perspectives (women and health workers), with two validated questionnaires including about
        100 quality measures based on the WHO Standards. It provides data on both the baseline
        assessment and the Quality Improvement component (progresses made).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Before-after study
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Quality of Maternal and Newborn Care Index evaluated by women
  time frame: At hospital discharge (assessed up to day 5)
  description: Evaluated by questionnaire
  measure: Quality of Maternal and Newborn Care Index evaluated by health professionals
  time frame: At hospital discharge (assessed up to day 5)
  description: Evaluated by questionnaire
  measure: Frequency of caesarean section
  time frame: At hospital discharge (assessed up to day 5)
  measure: Frequency of episiotomy
  time frame: At hospital discharge (assessed up to day 5)
  arm group label: WHO Standard implementation
  arm group type: Other
  intervention type: Other
  intervention name: Quality improvement recommendations (action plans)
  description: Developed and implemented at facility level to address key quality gaps emerging from the baseline assessment
  arm group label: WHO Standard implementation
  criteria: 
  gender: All
  gender based: Yes
  gender description: Women
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Marzia Lazzerini, MD
  role: Study Director
  affiliation: IRCCS materno infantile Burlo Garofolo
  last name: Marzia Lazzerini, MD
  phone: +390403785555
  email: marzia.lazzerini@burlo.trieste.it
  last name: Emanuelle Pessa Valente, MD
  email: emanuelle.pessavalente@burlo.trieste.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor