<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/NCT03271723</url>
  </required_header>
  <id_info>
    <org_study_id>C2015</org_study_id>
    <nct_id>NCT03271723</nct_id>
  </id_info>
  <brief_title>The 2015 Pelotas (Brazil) Birth Cohort Study</brief_title>
  <official_title>The 2015 Pelotas (Brazil) Birth Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Pelotas</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>
      This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including&#xD;
      more than 4 thousand children followed-up since the pre-natal period to study maternal-child&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since&#xD;
      1982. Data is being collected with a focus on maintaining fidelity to the tools and&#xD;
      instruments used in the previous cohorts with minimal adaptations when necessary. All&#xD;
      children born in Pelotas during 2015 were included in the cohort, and the cohort has been&#xD;
      followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study&#xD;
      identified and interviewed 73.8% of the mothers that subsequently delivered children that are&#xD;
      now part of the cohort. The 4275 children included in the cohort are part of extensive&#xD;
      assessments that include information on antenatal health and care, pregnancy health,&#xD;
      gestational age, physical activity, sleep, health behaviours, socio-demographic&#xD;
      characteristics, perinatal conditions, child anthropometry, delivery information, child&#xD;
      mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development,&#xD;
      access to health services, medicine use by both mother and child and genetic material. The&#xD;
      cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is&#xD;
      starting to be analyzed and, among other findings, confirm the already alarming trends in&#xD;
      surgical deliveries, amounting to 65.2% of all deliveries in 2015.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2014</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</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>Preterm birth</measure>
    <time_frame>At birth</time_frame>
    <description>Births before 37 weeks of pregnancy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Second trimester of pregnancy</time_frame>
    <description>Physical activities performed during pregnancy</description>
  </secondary_outcome>
  <enrollment type="Actual">4275</enrollment>
  <condition>Mother-Child Relations</condition>
  <condition>Preterm Birth</condition>
  <condition>Infant Development</condition>
  <condition>Breast Feeding</condition>
  <condition>Physical Activity</condition>
  <condition>Pregnancy Related</condition>
  <condition>Medicine, Narrative</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <description>No intervention</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All live births from mothers living in Pelotas during the year 2015 were included in the&#xD;
        birth cohort to be followed-up since birth.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  live births&#xD;
&#xD;
          -  mothers living in urban area of the city&#xD;
&#xD;
          -  delivered during 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  stillbirths below 500g&#xD;
&#xD;
          -  mothers living outside Pelotas&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Pedro C Hallal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego G Bassani, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SickKids, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariângela F Silveira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea D Bertoldi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Education School</name>
      <address>
        <city>Pelotas</city>
        <state>Rio Grande do Sul</state>
        <zip>96055-630</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.</citation>
    <PMID>26003406</PMID>
  </reference>
  <reference>
    <citation>Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.</citation>
    <PMID>27590170</PMID>
  </reference>
  <results_reference>
    <citation>Coll CVN, da Silveira MF, Bassani DG, Netsi E, Wehrmeister FC, Barros FC, Stein A. Antenatal depressive symptoms among pregnant women: Evidence from a Southern Brazilian population-based cohort study. J Affect Disord. 2017 Feb;209:140-146. doi: 10.1016/j.jad.2016.11.031. Epub 2016 Nov 26.</citation>
    <PMID>27914247</PMID>
  </results_reference>
  <results_reference>
    <citation>Coll CV, Domingues MR, Hallal PC, da Silva IC, Bassani DG, Matijasevich A, Barros A, Santos IS, Bertoldi AD. Changes in leisure-time physical activity among Brazilian pregnant women: comparison between two birth cohort studies (2004 - 2015). BMC Public Health. 2017 Jan 25;17(1):119. doi: 10.1186/s12889-017-4036-y.</citation>
    <PMID>28122524</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>MARLOS RODRIGUES DOMINGUES</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>cohort studies</keyword>
  <keyword>infant development</keyword>
  <keyword>pregnancy</keyword>
  <keyword>Brazil</keyword>
  <keyword>observational studies</keyword>
  <keyword>epidemiology</keyword>
  <keyword>maternal health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <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/NCT03271723
org study id: C2015
nct id: NCT03271723
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including
      more than 4 thousand children followed-up since the pre-natal period to study maternal-child
      health.
The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since
      1982. Data is being collected with a focus on maintaining fidelity to the tools and
      instruments used in the previous cohorts with minimal adaptations when necessary. All
      children born in Pelotas during 2015 were included in the cohort, and the cohort has been
      followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study
      identified and interviewed 73.8% of the mothers that subsequently delivered children that are
      now part of the cohort. The 4275 children included in the cohort are part of extensive
      assessments that include information on antenatal health and care, pregnancy health,
      gestational age, physical activity, sleep, health behaviours, socio-demographic
      characteristics, perinatal conditions, child anthropometry, delivery information, child
      mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development,
      access to health services, medicine use by both mother and child and genetic material. The
      cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is
      starting to be analyzed and, among other findings, confirm the already alarming trends in
      surgical deliveries, amounting to 65.2% of all deliveries in 2015.
observational model: Cohort
time perspective: Prospective
measure: Preterm birth
time frame: At birth
description: Births before 37 weeks of pregnancy
measure: Physical activity
time frame: Second trimester of pregnancy
description: Physical activities performed during pregnancy
intervention type: Other
intervention name: Observational study
description: No intervention
Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pedro C Hallal, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
last name: Diego G Bassani, PhD
role: Principal Investigator
affiliation: SickKids, Toronto
last name: Mariângela F Silveira, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
last name: Andrea D Bertoldi, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
facility: 
country: Brazil
citation: Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.
PMID: 26003406
citation: Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.
PMID: 27590170
citation: Coll CVN, da Silveira MF, Bassani DG, Netsi E, Wehrmeister FC, Barros FC, Stein A. Antenatal depressive symptoms among pregnant women: Evidence from a Southern Brazilian population-based cohort study. J Affect Disord. 2017 Feb;209:140-146. doi: 10.1016/j.jad.2016.11.031. Epub 2016 Nov 26.
PMID: 27914247
citation: Coll CV, Domingues MR, Hallal PC, da Silva IC, Bassani DG, Matijasevich A, Barros A, Santos IS, Bertoldi AD. Changes in leisure-time physical activity among Brazilian pregnant women: comparison between two birth cohort studies (2004 - 2015). BMC Public Health. 2017 Jan 25;17(1):119. doi: 10.1186/s12889-017-4036-y.
PMID: 28122524
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: MARLOS RODRIGUES DOMINGUES
investigator title: PhD
mesh term: Premature Birth
sharing ipd: No