Covid19 Clinical Trial
Official title:
Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.
NCT number | NCT04769700 |
Other study ID # | Lactancia1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | June 1, 2021 |
Verified date | September 2023 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Mexicano del Seguro Social | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social |
Mexico,
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 |
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