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Trial record 2 of 26 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

Tracking Information
First Submitted Date February 2, 2021
First Posted Date February 24, 2021
Last Update Posted Date February 24, 2021
Actual Study Start Date January 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2021)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19
Official Title Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.
Condition
  • Breast Feeding, Exclusive
  • Post Partum Depression
  • Covid19
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.
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 23, 2021)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
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.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alejandro González-Ojeda, MD, Ph.D +52333170060 ext 31309 avygail5@gmail.com
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04769700
Other Study ID Numbers Lactancia1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
Study Sponsor Instituto Mexicano del Seguro Social
Collaborators Not Provided
Investigators Not Provided
PRS Account Instituto Mexicano del Seguro Social
Verification Date February 2021