Breast Feeding, ExclusiveNCT04769700
Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19
An observational study of Breast Feeding, Exclusive and Post Partum Depression, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive, Post Partum Depression, Covid19
- What is being tested?
- Edinburgh Postnatal Depression Scale, Breast Feeding Adherence and Fear of Covid-19 Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.
Who may be able to join
- Women aged ≥18 years
- Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Feeding, Exclusive, Post Partum Depression, Covid19
- Being tested
- Edinburgh Postnatal Depression Scale, Breast Feeding Adherence, Fear of Covid-19 Scale
- Keywords
- COVID-19, Post-partum depression, Breast feeding, Pandemic
- Medical subject headings
- Breast Feeding, Depression, Postpartum, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edinburgh Postnatal Depression ScaleBehavioural
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.
Breast Feeding AdherenceBehavioural
This will be addressed according to the breastfeeding initiation practices according to the WHO.
Fear of Covid-19 ScaleBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Partum Depression Frequency
To explore the frequency of post-partum depression in women who gave birth during the COVID-19 pandemic
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769700
- Sponsor's protocol ID
- Lactancia1
- Status last verified
- Sep 2023
- First submitted
- 2 Feb 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04769700
- Acronym / sponsor ID
- Lactancia1
- Conditions
- Breast Feeding, Exclusive, Post Partum Depression, Covid19
- Keywords
- COVID-19, Post-partum depression, Breast feeding, Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.
Key inclusion criteria (2 listed)
- Women aged ≥18 years
- Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edinburgh Postnatal Depression ScaleThe 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. | Behavioural | – |
| Breast Feeding AdherenceThis will be addressed according to the breastfeeding initiation practices according to the WHO. | Behavioural | – |
| Fear of Covid-19 ScaleThe 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. | Behavioural | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, Exclusive and Post Partum Depression, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Partum Depression Frequency (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.