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Completed

NCT Number: NCT01660165

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

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. 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. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.

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Key information

Conditions

Pregnancy Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Personal Satisfaction Pregnancy Complications Psychological Well-Being Puerperal Disorders Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Municipal de Saúde Heitor Beltrão

Rio de Janeiro, 20521-160, Brazil

About this study

The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy and once in postpartum. Women are interviewed in four time points:

  • First trimester: 8th and 13th (baseline),
  • Second trimester: 22nd-24th gestational weeks,
  • Third trimester: 34th-36th gestational weeks,
  • Postpartum: 30-45 days

The following information will be gathered:

  • Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)
  • Dietary intake (food frequency questionnaire)
  • Anthropometric measure (stature and body weight) and physical activity
  • Biochemicals: fasting glucose, lipid profile (total cholesterol, HDL-c, LDL-c), serum fatty acid composition, inflammatory markers (C-reactive protein, interleukin-6), hormones (adiponectin, insulin, leptin).

All women are followed throughout pregnancy constituting the observational cohort. In the second trimester, those women identified as being in risk for PPD [past history of depression (DSM-IV) or presenting a score of depression (Edinburgh scale) >= 9 at the baseline interview] are invited to participate in the clinical trial. These women will be randomly allocated in two groups:

Intervention 1: Fish oil: [1,8 g/dia n-3 (1,08 g EPA e 0,72 g DHA)+ vit E (0,2 mg/g) Intervention 2: Placebo comparator: soybean oil + 1% fish oil + vit E (0,2 mg/g)

The supplementation occurs from the 22nd-24th week of pregnancy for 16 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • twin pregnancies

Treatment and study plan

Primary outcomes

  1. Major depressive episode

    Time frame: 30-45 days postpartum

    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.

Secondary outcomes

  1. Gestational weight gain

    Time frame: 34-36 weeks of gestation

    Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).

  2. Birth weight

    Time frame: Postpartum

    Neonatal birth weight (grams)

Other outcomes

  1. Serum fatty acids composition

    Time frame: 30-45 days of postpartum

    Change in n-3 (DHA, EPA) fatty acid composition (mg/dl or % of total fatty acids) throughout pregnancy and 30-45 postpartum.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 8, 2012
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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