Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-06-24
2023-11-30
Brief Summary
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Detailed Description
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Prenatal patients receiving care at a community health center in the Boston area will be invited to participate in the study at approximately 28 weeks gestation.
Participants will complete a baseline questionnaire prior to randomization which will occur at the \~36 week prenatal visit. A 1:1 randomization schedule will be applied.
Control arm: participants will be given usual care handouts and the study provider will provide anticipatory guidance and offer to answer any questions about breastfeeding.
Intervention arm: participants will be shown the breastfeeding education video on a study tablet, and provided a QR code which will give them access to the associated website. After watching the video, study staff will then offer to review hand expression by answering questions and reviewing steps, and physically helping the patient to practice hand expression. Hands-on teaching of hand expression will be opt-in only and not required for study participation.
Text messages will be sent to the intervention arm participants with the link to the intervention video and website, and a brief message reminding them to review the materials and to hand express frequently starting immediately after delivery.
All participants (both arms) will be contacted to fill out a very brief, 10-item questionnaire (approximately 5 minutes) at 3 days postpartum, and short questionnaires (10-15 minutes) at 14 days and 60 days postpartum. Questionnaires will ask about use of hand expression, breastfeeding, formula use, perceived breastfeeding problems, breastfeeding efficacy and satisfaction with prenatal breastfeeding education. In all questionnaires participants will be asked about pain and potential adverse events.
Participant and neonatal electronic medical records will reviewed through 2 months postpartum.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
Participants randomized to the intervention group will receive breastfeeding education and teaching of hand expression using a breastfeeding education video and associated breastfeeding website, as well as hands-on teaching of hand expression techniques during their 36 week visit.
Breastfeeding education video
An introductory video (15 minutes) gives an overview of these "ABCs" (video titled "Term baby" which are further taught through brief text summaries (150-200 words) and short instructional videos (2-6 minutes).
Breastfeeding website
The website firstdroplets.com is designed for prenatal education, focusing on the "ABCs of breastfeeding that come before D (delivery)" - attachment (latch), breastmilk production, and calories (transfer of milk to baby).
Control group
Participants randomized to the control group will receive usual breastfeeding education during their 36-week visit.
Usual breastfeed education
The usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice
Interventions
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Breastfeeding education video
An introductory video (15 minutes) gives an overview of these "ABCs" (video titled "Term baby" which are further taught through brief text summaries (150-200 words) and short instructional videos (2-6 minutes).
Breastfeeding website
The website firstdroplets.com is designed for prenatal education, focusing on the "ABCs of breastfeeding that come before D (delivery)" - attachment (latch), breastmilk production, and calories (transfer of milk to baby).
Usual breastfeed education
The usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice
Eligibility Criteria
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Inclusion Criteria
* Receiving prenatal care at Manet Community Health Center
* Speaks and understands English
* Infants born to the included adult subjects (infants are subjects for chart review only)
Exclusion Criteria
* Fetal demise or neonatal death (after patient is consented into the study)
* Severe maternal illness significant limiting ability to perform hand expression (e.g. admission to ICU during admission for labor and delivery)
18 Years
FEMALE
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Katherine Standish, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Manet Community Health Center
Quincy, Massachusetts, United States
Countries
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Other Identifiers
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H-39614
Identifier Type: -
Identifier Source: org_study_id