Study Stopped
This pilot study was planned just prior to and during the covid-19 pandemic and was not able to begin due to changes in staffing availability and clinic logistics during the pandemic.
Prenatal Breastfeeding Education
First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education
1 other identifier
interventional
N/A
1 country
1
Brief Summary
In this pilot randomized control trial, the investigators will evaluate the feasibility and acceptability of using a video and website in a prenatal visit to provide breastfeeding education, focusing on how to hand express (HE) breast milk. Participants will be randomized to the video/website intervention group or to the control standard of care group. After delivery, participants will be asked to provide information on how long they breastfed and if they used the information in the video and website. Differences in the outcome measures will be analyzed between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedNovember 30, 2023
November 1, 2023
2.4 years
September 9, 2020
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion using hand expression
Proportion of respondents who have performed hand expression since their baby was born
3 days post partum
Mean times hand expression in past 24 hours
Mean number of times performed hand expression in past 24 hours
3 days post partum
Mean hand expression experience scale
Mean score on the following set of questions (adapted from the Breast Milk Expression Experience measure): How much do you agree with the following? (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree) 1. My family members support hand expression. 2. My partner supports hand expression. 3. I feel peaceful when hand expressing. 4. I look forward to hand expressing. 5. I enjoy hand expressing. 6. Hand expressing is something I could do easily while doing other things. 7. Hand expressing feels awkward. 8. Hand expression makes me feel confident my baby is getting enough milk
3 days post partum
Secondary Outcomes (6)
Proportion exclusively breastfeeding
2 months
Proportion any breastfeeding
2 months
Breast feeding self-efficacy
14 days
Proportion with concern for low milk production
14 days
Hand expression comprehension
36 weeks gestation
- +1 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALParticipants 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.
Control group
ACTIVE COMPARATORParticipants randomized to the control group will receive usual breastfeeding education during their 36-week visit.
Interventions
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).
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).
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
You may qualify if:
- Pregnant
- 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)
You may not qualify if:
- Contraindication to breastfeeding (HIV positive or active substance use disorder)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manet Community Health Center
Quincy, Massachusetts, 02171, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Standish, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 16, 2020
Study Start
June 24, 2021
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share