<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/NCT02994810</url>
  </required_header>
  <id_info>
    <org_study_id>HMV - Breastfeeding</org_study_id>
    <nct_id>NCT02994810</nct_id>
  </id_info>
  <brief_title>Orientation Effects of Breastfeeding for Mothers</brief_title>
  <official_title>Orientation Effects of Breastfeeding for Mothers in a Private Hospital: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Moinhos de Vento</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The benefits of breastfeeding are increasingly known of the population and breastfeeding&#xD;
      rates in the country have been increasing, but still are below satisfactory to the Ministry&#xD;
      of Health (MH) and the World Health Organization (WHO).&#xD;
&#xD;
      Simple Strategies to guide and support the mother contributes to increasing knowledge about&#xD;
      breastfeeding and can have positive impacts on breastfeeding rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the&#xD;
      first six months of a baby's life.&#xD;
&#xD;
      110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.&#xD;
&#xD;
      The first stage was carried out in the maternity - Orientation: Breastfeeding Importance&#xD;
      Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the&#xD;
      intervention group held three home visits:&#xD;
&#xD;
      10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for&#xD;
      both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of Breastfeeding for Mothers measured by structured questionnaire</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Breastfeeding</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guidelines and review of the breastfeeding techniques.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding guidance</intervention_name>
    <description>Breastfeeding guidance</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers living in the city of Porto Alegre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm&#xD;
             infants, twin hospitalized&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Salete de matos</name>
      <address>
        <city>Porto Alegre</city>
        <zip>91215200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Moinhos de Vento</investigator_affiliation>
    <investigator_full_name>Salete Matos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Orientation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02994810
org study id: HMV - Breastfeeding
nct id: NCT02994810
lead sponsor: 
has dmc: No
The benefits of breastfeeding are increasingly known of the population and breastfeeding
      rates in the country have been increasing, but still are below satisfactory to the Ministry
      of Health (MH) and the World Health Organization (WHO).

      Simple Strategies to guide and support the mother contributes to increasing knowledge about
      breastfeeding and can have positive impacts on breastfeeding rates.
Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the
      first six months of a baby's life.

      110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.

      The first stage was carried out in the maternity - Orientation: Breastfeeding Importance
      Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the
      intervention group held three home visits:

      10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for
      both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Effects of Breastfeeding for Mothers measured by structured questionnaire
time frame: Six months
arm group label: Intervention group
arm group type: Experimental
description: Guidelines and review of the breastfeeding techniques.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding.
intervention type: Other
intervention name: Breastfeeding guidance
description: Breastfeeding guidance
arm group label: Intervention group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Moinhos de Vento
investigator full name: Salete Matos
investigator title: Principal Investigator
sharing ipd: No