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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660165
• Other study ID #: CAAE 0139.0.314.000-09
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: January 16, 2014
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: January 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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. 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.

Description:

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

1. First trimester: 8th and 13th (baseline),

2. Second trimester: 22nd-24th gestational weeks,

3. Third trimester: 34th-36th gestational weeks,

4. Postpartum: 30-45 days

The following information will be gathered:

1. Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)

2. Dietary intake (food frequency questionnaire)

3. Anthropometric measure (stature and body weight) and physical activity

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: July 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Brazil	Centro Municipal de Saúde Heitor Beltrão	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum fatty acids composition	Change in n-3 (DHA, EPA) fatty acid composition (mg/dl or % of total fatty acids) throughout pregnancy and 30-45 postpartum.	30-45 days of postpartum	No
Primary	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	No
Secondary	Gestational weight gain	Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).	34-36 weeks of gestation	No
Secondary	Birth weight	Neonatal birth weight (grams)	Postpartum	No