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CompletedNCT03271723Updated Sep 5, 2017

The 2015 Pelotas (Brazil) Birth Cohort Study

An observational study in Mother-Child Relations, Preterm Birth and Infant Development, sponsored by Federal University of Pelotas. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Federal University of Pelotas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,275
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Premature Birth with a site in Brazil — 4 open to participants now, 6 under way, none of them phase 3. Premature Birth · Brazil.

Started
2014
with 4 others
Observational
5 of 41
1 open now
Registered
29th of 41
by date
Lead sponsor
2 of 41
Federal University of Pelotas

Among the 41 studies in Premature Birth with a site in Brazil, this one is one of 5 that started in 2014, is one of 5 observational ones, and was the 29th registered.

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

Browse Premature Birth studies →

Open to participants now

4 of the 41 studies in Premature Birth with a site in Brazil are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Premature Birth with a site in Brazil, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Mother-Child Relations
  • Preterm Birth
  • Infant Development
  • Breast Feeding
  • Physical Activity
  • Pregnancy Related
  • Medicine, Narrative

Keywords

  • cohort studies
  • infant development
  • pregnancy
  • Brazil
  • observational studies
  • epidemiology
  • maternal health
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • stillbirths below 500g
  • mothers living outside Pelotas
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,275 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherObservational study

    No intervention

06

What researchers measure

Primary outcomes

  1. Preterm birth

    Births before 37 weeks of pregnancy

    Time frame: At birth

Secondary outcomes

  1. Physical activity

    Physical activities performed during pregnancy

    Time frame: Second trimester of pregnancy

07

Study locations

1 site
  • Physical Education School
    Pelotas, Rio Grande do Sul 96055-630, Brazil
08

References and documents

Publications

  • 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. PubMed 26003406 ↗
  • 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. PubMed 27590170 ↗
  • 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. PubMed 27914247 ↗
  • 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. PubMed 28122524 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2014 to primary completion in Dec 2014, 8 months.

Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 8 months is below that.

Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2017
First posted
Sep 5, 2017
StartActual
Apr 15, 2014
Primary completionActual
Dec 31, 2014
CompletionActual
Dec 31, 2015
Last update
Sep 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03271723
Lead sponsor
Federal University of Pelotas
Collaborators
Wellcome Trust
Responsible party
MARLOS RODRIGUES DOMINGUES (PhD, Federal University of Pelotas) — Principal investigator
First posted
Sep 5, 2017
Start date
Apr 15, 2014
Primary completion
Dec 31, 2014
Completion
Dec 31, 2015
Last update
Sep 5, 2017

Study contacts

Pedro C Hallal, PhD
principal investigator · Federal University of Pelotas
Diego G Bassani, PhD
principal investigator · SickKids, Toronto
Mariângela F Silveira, PhD
principal investigator · Federal University of Pelotas
Andrea D Bertoldi, PhD
principal investigator · Federal University of Pelotas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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