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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769700
• Other study ID #: Lactancia1
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• COVID-19
• Covid19
• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

Behavioral:
• Edinburgh Postnatal Depression Scale
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
This will be addressed according to the breastfeeding initiation practices according to the WHO.
• Fear of Covid-19 Scale
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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Partum Depression Frequency	To explore the frequency of post-partum depression in women who gave birth during the COVID-19 pandemic	Baseline
Primary	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
Primary	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