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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT04476940 |
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Date of registration:
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13/07/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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COVID-19 Breastfeeding Guideline for African-Americans
COVID-BF |
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Scientific title:
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An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers |
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Date of first enrolment:
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September 1, 2020 |
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Target sample size:
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200 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04476940 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Carlton Z Adams, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Meharry Medical College |
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Name:
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Flora A Ukoli, M.D., MPH. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Meharry Medical College |
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Name:
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Samuel E Adunyah, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Meharry Medical College |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Assessment Survey: Mothers who had a baby in 2020.
- Intervention Participants: Women in late 2nd or 3rd pregnancy trimester enrolled for
prenatal care by participating physicians.
Exclusion Criteria:
- Assessment Survey: Mothers who had a baby prior to 2020.
- Intervention Participants: Not pregnant, in 1st trimester of pregnancy, not enrolled
for prenatal care by participating physician.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Exclusive Breastfeeding
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Covid19
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Intervention(s)
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Behavioral: COVID-19 Breastfeeding Support
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Primary Outcome(s)
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COVID-19 breastfeeding guidance adherence at 1-month postpartum.
[Time Frame: At 1-month postpartum.]
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COVID-19 breastfeeding guidance adherence at 3-months postpartum.
[Time Frame: At 3-months postpartum.]
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Exclusive breastfeeding at 3-months.
[Time Frame: At 3-months.]
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COVID-19 breastfeeding guidance adherence at birth.
[Time Frame: At birth.]
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Exclusive breastfeeding at 1-month.
[Time Frame: At 1-month.]
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Exclusive breastfeeding at birth.
[Time Frame: At birth.]
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Secondary Outcome(s)
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COVID-19 Immunoglobulin G
[Time Frame: 3-months postpartum]
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COVID-19 Immunoglobulin M
[Time Frame: 3-months postpartum]
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COVID_Status
[Time Frame: 3-months postpartum]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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