Clinical trial NCT03271723: The 2015 Pelotas (Brazil) Birth Cohort Study
Official title: The 2015 Pelotas (Brazil) Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2017-09-05
Enrollment: 4275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* stillbirths below 500g
* mothers living outside Pelotas

Primary outcomes:
measure: Preterm birth
timeFrame: At birth
Secondary outcomes:
measure: Physical activity
timeFrame: Second trimester of pregnancy
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Physical Education School
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Pedro C Hallal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SickKids, Toronto
name: Diego G Bassani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Mariângela F Silveira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Andrea D Bertoldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.