Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19

NCT04769700 | Completed

• 1 other identifier: Lactancia1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore whether quarantine measures, social distancing and hospital containment policies among women giving birth during the COVID-19 pandemic enhanced psycho-emotional distress in the immediate postpartum period. The investigators tested for depression using the Edinburgh Postnatal Depression Scale (EPDS) in the first 6 postpartum months, and then used the Fear of COVID-19 Scale, measuring also the adherence and practices of breastfeeding according to WHO.

Conditions

Breast Feeding, Exclusive; Post Partum Depression; Covid19

Keywords

COVID-19; Post-partum depression; Breast feeding; Pandemic

Outcome Measures

Primary Outcomes (3)

• Post-Partum Depression Frequency

  To explore the frequency of post-partum depression in women who gave birth during the COVID-19 pandemic

  Baseline

• Breast Feeding Adherence and behavior.

  To explore the breastfeeding behavior of women who gave birth during the COVID-19 pandemic. The investigators asked the patients about the frequency of breastfeeding, the duration in months of how long the mothers breastfed in a previous child, if the participants have breastfed before, and whether the participants exclusively breastfed or complemented the nutrition with formula.

  Baseline

• Fear of Covid-19 severity

  The Fear of Covid-19 Scale (FCV-19S) is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. The FVC-19S consists of seven items, such as "It makes me uncomfortable to think about coronavirus-19," "I am afraid of losing my life because of coronavirus-19," and "When watching news and stories about coronavirus-19 on social media, I become nervous or anxious," each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19.

  Baseline

Interventions

Edinburgh Postnatal Depression Scale BEHAVIORAL

The Edinburgh Postnatal Depression Scale is a self-administered questionnaire made up of 10 items scored using a four-point Likert scale (0-3) designed to screen for symptoms of postpartum depression. Postpartum depression represents the end of a continuum of severity of symptoms. The present study used a cutoff point for depressive symptomatology risk of higher than 12.

Breast Feeding Adherence BEHAVIORAL

This will be addressed according to the breastfeeding initiation practices according to the WHO.

Fear of Covid-19 Scale BEHAVIORAL

The Fear of Covid-19 Scale is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. It consists of seven items, each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.

You may qualify if:

• Women aged ≥18 years
• Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic

You may not qualify if:

• Women who delivered two or more products
• Women who delivered singletons at term past the last 6 months during the COVID-19 pandemic
• Women who delivered singletons pre or post-term in the last 6 months during the COVID-19 pandemic

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, 44329, Mexico

Location

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum; COVID-19

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 24, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

ME (1)