Hormones in the plasma and milk of women in the first year postpartum: association with depressive symptoms and baby development

Recruiting

• Conditions: Depression, Postpartum; C12.050.703.844

• Registration Number: RBR-9hcby8c
• Lead Sponsor: Instituto Nacional de Saúde da Mulher da Criança e do Adolescente Fernandes Figueira/ Fundação Oswaldo Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 23 January 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Breastfeeding mothers up to 15 days postpartum; aged between 20 and 45 of age; exclusively breastfeeding (offering only breast milk without tea or water in the 5 days preceding entry into the study); be free from chronic non-communicable diseases such as high blood pressure and diabetes, except obesity; residing in the city of Rio de Janeiro; be free from infectious diseases such as HIV; proficient in the Portuguese language; and whose newborns had an Apgar score = 7 at the fifth minute

Exclusion Criteria

Breastfeeding mothers using antidepressant medication or other psychiatric medication; who had a twin pregnancy; who tested positive for Syphilis, Rubella, Toxoplasmosis, Cytomegalovirus, or Zika during pregnancy; who had gestational surrogacy/temporary uterine donation ('gestational carrier'); whose newborn had a premature birth, any pathology, inappropriate weight for gestational age, a diagnosis of any condition or malformation known to cause motor and/or cognitive deficits, or was admitted to a neonatal intensive care unit

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate infant neurodevelopment using the Bayley Scales of Infant and Toddler Development III (Bayley-III), analyzed on a continuous scale;To assess postpartum depression, the Edinburgh Postnatal Depression Scale (EPDS) will be used, considering that women with a score equal to or greater than 13 are classified as having depressive symptoms

Secondary Outcome Measures

Name	Time	Method
Assess maternal and infant body composition (weight, percentage of fat, percentage of lean mass) using plethysmography, analyzed continuously