<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/NCT03810716</url>
  </required_header>
  <id_info>
    <org_study_id>SIDISI: 102347</org_study_id>
    <nct_id>NCT03810716</nct_id>
  </id_info>
  <brief_title>Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services</brief_title>
  <official_title>Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Peruana Cayetano Heredia</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>
      Family planning and the use of contraceptive methods are of the main strategies to reduce&#xD;
      maternal and perinatal morbidity and mortality, because they can prevent unplanned&#xD;
      pregnancies, teenage pregnancies and abortions in dangerous conditions. It is also a tool&#xD;
      that contributes to development as it improves children's health, improves access to early&#xD;
      childhood education, empowers women and contributes to reducing poverty as it improves&#xD;
      economic conditions.&#xD;
&#xD;
      Currently the use of modern contraceptive methods has increased worldwide, in Latin America&#xD;
      and the Caribbean the use of modern contraceptive methods has remained at 66.07% from 2008 to&#xD;
      2015. However, the number of women who do not want to get pregnant and that do not use a&#xD;
      contraceptive method is still high - 214 million women of childbearing age in developed&#xD;
      countries.&#xD;
&#xD;
      In our country according to the ENDES 2016 survey, the number of women who used a&#xD;
      contraceptive method decreased by 0.7 percent compared to 2012, of which 54.3 percent used&#xD;
      some modern contraceptive method and 21.9 percent some method traditional.&#xD;
&#xD;
      The unmet demand for family planning in 2016 was 6.0%, affecting mainly women from the lowest&#xD;
      poverty quintile (7.4%) and those living in rural areas (6.8%).&#xD;
&#xD;
      Of the women who were surveyed and did not use a contraceptive method, 80.6% did not talk&#xD;
      about family planning either at home or in a health facility in the last 12 months. Only&#xD;
      16.3% of non-users were women who attended a health facility and received information on&#xD;
      family planning.&#xD;
&#xD;
      Through this study the investigators propose the design and evaluation of an interactive&#xD;
      platform to promote modern contraceptive methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample Size: Sample size of 176 participants (interventional group=88, control group=88), it&#xD;
      is possible to detect minimum differences of 5% to 20%.&#xD;
&#xD;
      Statistical analysis plan: The data collected will be entered into a database in Microsoft&#xD;
      Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be&#xD;
      analyzed by frequencies and percentages, the quantitative variables by relative risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Actual">December 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Quasi - experimental study design.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of mothers who attend the family planning service</measure>
    <time_frame>one month</time_frame>
    <description>Percentage of women who assist to family planning service after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of mothers who initiate a contraceptive method</measure>
    <time_frame>one month after the intervention</time_frame>
    <description>Percentage of mothers who initiate a contraceptive method after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the users about the interactive platform</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>The participants will answer a survey to rate usability after the intervention. This survey is a likert survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Women</condition>
  <arm_group>
    <arm_group_label>Interactive Platform</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tha participants in this group will see the interactive platform and answer a survey before and after the intervention. Their clinical health records will be checked one month ago.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants in this group will answer the survey. Their clinical health records will be checked one month ago.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Interactive Platform</intervention_name>
    <description>The participants will see the interactive platform.</description>
    <arm_group_label>Interactive Platform</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers of children who attend the service of growth and development who are of legal&#xD;
             age&#xD;
&#xD;
          -  Women who do not currently use some modern contraceptive method&#xD;
&#xD;
          -  Women whose partners have not received voluntary surgical contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teen mothers&#xD;
&#xD;
          -  Illiterate women&#xD;
&#xD;
          -  Women who currently do not have a partner&#xD;
&#xD;
          -  Women who are currently gestating&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzzane S Minaya Romero, BSc</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Cueto Fernandini</name>
      <address>
        <city>Lima</city>
        <state>Los Olivos</state>
        <zip>L39</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Olivos</name>
      <address>
        <city>Lima</city>
        <state>Los Olivos</state>
        <zip>L39</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <link>
    <url>http://www.scielo.org.pe/pdf/rins/v30n3/a16v30n3.pdf</url>
    <description>LA PLANIFICACIÓN FAMILIAR COMO HERRAMIENTA BÁSICA PARA EL DESARROLLO FAMILY PLANNING AS A BASIC TOOL FOR DEVELOPMENT</description>
  </link>
  <results_reference>
    <citation>Sheoran B, Braun RA, Gaarde JP, Levine DK. The hookup: collaborative evaluation of a youth sexual health program using text messaging technology. JMIR Mhealth Uhealth. 2014 Nov 3;2(4):e51. doi: 10.2196/mhealth.3583.</citation>
    <PMID>25367444</PMID>
  </results_reference>
  <results_reference>
    <citation>Mishra N, Panda M, Pyne S, Srinivas N, Pati S, Pati S. Barriers and enablers to adoption of intrauterine device as a contraceptive method: A multi-stakeholder perspective. J Family Med Prim Care. 2017 Jul-Sep;6(3):616-621. doi: 10.4103/2249-4863.222028.</citation>
    <PMID>29417019</PMID>
  </results_reference>
  <results_reference>
    <citation>Ngum Chi Watts MC, Liamputtong P, Carolan M. Contraception knowledge and attitudes: truths and myths among African Australian teenage mothers in Greater Melbourne, Australia. J Clin Nurs. 2014 Aug;23(15-16):2131-41. doi: 10.1111/jocn.12335. Epub 2013 Sep 13.</citation>
    <PMID>24028778</PMID>
  </results_reference>
  <results_reference>
    <citation>Ewerling F, Victora CG, Raj A, Coll CVN, Hellwig F, Barros AJD. Demand for family planning satisfied with modern methods among sexually active women in low- and middle-income countries: who is lagging behind? Reprod Health. 2018 Mar 6;15(1):42. doi: 10.1186/s12978-018-0483-x.</citation>
    <PMID>29510682</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Peruana Cayetano Heredia</investigator_affiliation>
    <investigator_full_name>Suzzane Minaya Romero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>interactive platform</keyword>
  <keyword>family planning</keyword>
  <keyword>contraception</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan description. No applicable.</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/NCT03810716
org study id: SIDISI: 102347
nct id: NCT03810716
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Family planning and the use of contraceptive methods are of the main strategies to reduce
      maternal and perinatal morbidity and mortality, because they can prevent unplanned
      pregnancies, teenage pregnancies and abortions in dangerous conditions. It is also a tool
      that contributes to development as it improves children's health, improves access to early
      childhood education, empowers women and contributes to reducing poverty as it improves
      economic conditions.

      Currently the use of modern contraceptive methods has increased worldwide, in Latin America
      and the Caribbean the use of modern contraceptive methods has remained at 66.07% from 2008 to
      2015. However, the number of women who do not want to get pregnant and that do not use a
      contraceptive method is still high - 214 million women of childbearing age in developed
      countries.

      In our country according to the ENDES 2016 survey, the number of women who used a
      contraceptive method decreased by 0.7 percent compared to 2012, of which 54.3 percent used
      some modern contraceptive method and 21.9 percent some method traditional.

      The unmet demand for family planning in 2016 was 6.0%, affecting mainly women from the lowest
      poverty quintile (7.4%) and those living in rural areas (6.8%).

      Of the women who were surveyed and did not use a contraceptive method, 80.6% did not talk
      about family planning either at home or in a health facility in the last 12 months. Only
      16.3% of non-users were women who attended a health facility and received information on
      family planning.

      Through this study the investigators propose the design and evaluation of an interactive
      platform to promote modern contraceptive methods.
Sample Size: Sample size of 176 participants (interventional group=88, control group=88), it
      is possible to detect minimum differences of 5% to 20%.

      Statistical analysis plan: The data collected will be entered into a database in Microsoft
      Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be
      analyzed by frequencies and percentages, the quantitative variables by relative risk.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Quasi - experimental study design.
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of mothers who attend the family planning service
time frame: one month
description: Percentage of women who assist to family planning service after the intervention
measure: Percentage of mothers who initiate a contraceptive method
time frame: one month after the intervention
description: Percentage of mothers who initiate a contraceptive method after the intervention
measure: Satisfaction of the users about the interactive platform
time frame: immediately after the intervention
description: The participants will answer a survey to rate usability after the intervention. This survey is a likert survey.
arm group label: Interactive Platform
arm group type: Experimental
description: Tha participants in this group will see the interactive platform and answer a survey before and after the intervention. Their clinical health records will be checked one month ago.
arm group label: Control
arm group type: No Intervention
description: The participants in this group will answer the survey. Their clinical health records will be checked one month ago.
intervention type: Device
intervention name: Interactive Platform
description: The participants will see the interactive platform.
arm group label: Interactive Platform
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suzzane S Minaya Romero, BSc
role: Principal Investigator
facility: 
facility: 
country: Peru
url: http://www.scielo.org.pe/pdf/rins/v30n3/a16v30n3.pdf
description: LA PLANIFICACIÓN FAMILIAR COMO HERRAMIENTA BÁSICA PARA EL DESARROLLO FAMILY PLANNING AS A BASIC TOOL FOR DEVELOPMENT
citation: Sheoran B, Braun RA, Gaarde JP, Levine DK. The hookup: collaborative evaluation of a youth sexual health program using text messaging technology. JMIR Mhealth Uhealth. 2014 Nov 3;2(4):e51. doi: 10.2196/mhealth.3583.
PMID: 25367444
citation: Mishra N, Panda M, Pyne S, Srinivas N, Pati S, Pati S. Barriers and enablers to adoption of intrauterine device as a contraceptive method: A multi-stakeholder perspective. J Family Med Prim Care. 2017 Jul-Sep;6(3):616-621. doi: 10.4103/2249-4863.222028.
PMID: 29417019
citation: Ngum Chi Watts MC, Liamputtong P, Carolan M. Contraception knowledge and attitudes: truths and myths among African Australian teenage mothers in Greater Melbourne, Australia. J Clin Nurs. 2014 Aug;23(15-16):2131-41. doi: 10.1111/jocn.12335. Epub 2013 Sep 13.
PMID: 24028778
citation: Ewerling F, Victora CG, Raj A, Coll CVN, Hellwig F, Barros AJD. Demand for family planning satisfied with modern methods among sexually active women in low- and middle-income countries: who is lagging behind? Reprod Health. 2018 Mar 6;15(1):42. doi: 10.1186/s12978-018-0483-x.
PMID: 29510682
responsible party type: Principal Investigator
investigator affiliation: Universidad Peruana Cayetano Heredia
investigator full name: Suzzane Minaya Romero
investigator title: Principal Investigator
sharing ipd: No
ipd description: There is no plan description. No applicable.