Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil

NCT01660165 | Completed

• 1 other identifier: CAAE 0139.0.314.000-09
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing evidence that psychosocial factors may affect health by means of biological effects and changes in behavioral health. Observational studies suggest an association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid), after pregnancy and the occurrence of postpartum depression (PPD). This is an observational cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in the city of Rio de Janeiro. The general objective is to describe the magnitude and identify factors associated to common mental disorders (CMD) during pregnancy and postpartum giving emphasis to maternal nutritional status. Main specific objectives:

1. 1.To evaluate the effect of CMD in the pattern of occurrence of selected maternal and child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low birthweight, small for gestational weight and prematurity), considering the effect of other determinant factors, and
2. 2.To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.

Conditions

Pregnancy

Keywords

Nutritional status; Mental Health; Omega-3; Pregnancy; Postpartum depression

Outcome Measures

Primary Outcomes (1)

• Major depressive episode

  Number of women with diagnostic of major depression in the postpartum visit (30-45 days after childbirth) using Edinburgh scale and the MINI psychiatry interview.

  30-45 days postpartum

Secondary Outcomes (2)

• Gestational weight gain

  34-36 weeks of gestation

• Birth weight

  Postpartum

Other Outcomes (1)

• Serum fatty acids composition

  30-45 days of postpartum

Study Arms (1)

Observational

Pregnant women

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil

You may qualify if:

• aged 20 to 40
• up to 13 weeks of pregnancy
• free from chronic or infectious diseases (except obesity)
• residing in the study catchment area

You may not qualify if:

• \- twin pregnancies

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Centro Municipal de Saúde Heitor Beltrão

Rio de Janeiro, Rio de Janeiro, 20521-160, Brazil

Location

Related Publications (1)

• Vaz JDS, Farias DR, Adegboye ARA, Nardi AE, Kac G. Omega-3 supplementation from pregnancy to postpartum to prevent depressive symptoms: a randomized placebo-controlled trial. BMC Pregnancy Childbirth. 2017 Jun 9;17(1):180. doi: 10.1186/s12884-017-1365-x.

  PMID: 28599630 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fatty acids C-reactive protein Interleukin-6

MeSH Terms

Conditions

Psychological Well-Being; Depression, Postpartum

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Gilberto Kac, Phd

  Universidade Federal do Rio de Janeiro

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: August 8, 2012
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

BR (1)