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Completed

NCT Number: NCT04769700

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

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.

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Key information

Conditions

Breast Feeding, Exclusive Behavior Breast Feeding COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Mental Disorders Mood Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Post Partum Depression Pregnancy Complications Puerperal Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, 44329, Mexico

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Post-Partum Depression Frequency

    Time frame: Baseline

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

  2. Breast Feeding Adherence and behavior.

    Time frame: Baseline

    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.

  3. Fear of Covid-19 severity

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Oct 2, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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