The 2015 Pelotas (Brazil) Birth Cohort Study

Physical Activity Clinical Trial

Official title:

The 2015 Pelotas (Brazil) Birth Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271723
• Other study ID #: C2015
• Status: Completed
• Phase: N/A
• First received: August 25, 2017
• Last updated: August 31, 2017
• Start date: April 15, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: August 2017
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4275
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• live births

• mothers living in urban area of the city

• delivered during 2015

Exclusion Criteria:

• stillbirths below 500g

• mothers living outside Pelotas

Related Conditions & MeSH terms

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

Intervention

Other:
• Observational study
No intervention

Locations

Country	Name	City	State
Brazil	Physical Education School	Pelotas	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Pelotas	Wellcome Trust

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Coll CV, 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.j — View 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 He — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	Births before 37 weeks of pregnancy	At birth
Secondary	Physical activity	Physical activities performed during pregnancy	Second trimester of pregnancy