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

September 29, 2023 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lactancia1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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