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

NCT ID: NCT04769700

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Feeding, Exclusive Post Partum Depression Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Breast Feeding Adherence

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lactancia1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mother-Baby Study - Observational
NCT06039878 RECRUITING NA
New at Parenting Study
NCT07076381 COMPLETED NA