NCT03271723

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

August 25, 2017

Last Update Submit

August 31, 2017

Conditions

Mother-Child RelationsPreterm BirthInfant DevelopmentBreast FeedingPhysical ActivityPregnancy RelatedMedicine, Narrative

Keywords

cohort studiesinfant developmentpregnancyBrazilobservational studiesepidemiologymaternal health

Outcome Measures

Primary Outcomes (1)

  • Preterm birth

    Births before 37 weeks of pregnancy

    At birth

Secondary Outcomes (1)

  • Physical activity

    Second trimester of pregnancy

Interventions

Observational studyOTHER

No intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All live births from mothers living in Pelotas during the year 2015 were included in the birth cohort to be followed-up since birth.

You may qualify if:

  • live births
  • mothers living in urban area of the city
  • delivered during 2015

You may not qualify if:

  • stillbirths below 500g
  • mothers living outside Pelotas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Education School

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (4)

  • 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: 26003406BACKGROUND

  • 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: 27590170BACKGROUND

  • 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: 27914247RESULT

  • 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: 28122524RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Premature BirthBreast FeedingMotor ActivityNarrative Medicine

Interventions

Observation

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehaviorNarrationCommunication

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Pedro C Hallal, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

  • Diego G Bassani, PhD

    SickKids, Toronto

    PRINCIPAL INVESTIGATOR

  • Mariângela F Silveira, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

  • Andrea D Bertoldi, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 25, 2017

First Posted

September 5, 2017

Study Start

April 15, 2014

Primary Completion

December 31, 2014

Study Completion

December 31, 2015

Last Updated

September 5, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)