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Trial record 2 of 25 for:    breastfeeding | Covid19

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

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ClinicalTrials.gov Identifier: NCT04769700
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

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.

Condition or disease Intervention/treatment
Breast Feeding, Exclusive Post Partum Depression Covid19 Behavioral: Edinburgh Postnatal Depression Scale Behavioral: Breast Feeding Adherence Behavioral: Fear of Covid-19 Scale

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.
  • Behavioral: Breast Feeding Adherence
    This will be addressed according to the breastfeeding initiation practices according to the WHO.
  • 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.


Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769700


Contacts
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Contact: Alejandro González-Ojeda, MD, Ph.D +52333170060 ext 31309 avygail5@gmail.com

Locations
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Mexico
Instituto Mexicano del Seguro Social Recruiting
Guadalajara, Jalisco, Mexico, 44329
Contact: Alejandro Gonzalez Ojeda, PhD    +52333170060 ext 31309    avygail5@gmail.com   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
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Responsible Party: GONZALEZ-OJEDA ALEJANDRO, Principal Investigator, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT04769700    
Other Study ID Numbers: Lactancia1
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social:
COVID-19
Post-partum depression
Breast feeding
Pandemic
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications