First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Boston Medical Center
- Locations
- 1
- Primary Endpoint
- Proportion using hand expression
Study Overview
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.
Detailed Description
This study aims to evaluate the feasibility of a new method for teaching breastfeeding skills, and may provide evidence that hand expression (HE) to augment milk production in the first days postpartum can help women breastfeed. Few studies have evaluated the use of HE for improving breastfeeding outcomes. This study will also evaluate the impact of a new video/website which can be utilized widely and adapted for other populations, both in clinical and non-clinical settings.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
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.
Intervention: Breastfeeding education video (Behavioral)
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.
Intervention: Breastfeeding website (Behavioral)
Control group
Participants randomized to the control group will receive usual breastfeeding education during their 36-week visit.
Intervention: Usual breastfeed education (Behavioral)
Outcomes
Primary Outcomes
Proportion using hand expression
Time Frame: 3 days post partum
Proportion of respondents who have performed hand expression since their baby was born
Mean hand expression experience scale
Time Frame: 3 days post partum
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
Mean times hand expression in past 24 hours
Time Frame: 3 days post partum
Mean number of times performed hand expression in past 24 hours
Secondary Outcomes
- Satisfaction with video(36 weeks gestation)
- Proportion with concern for low milk production(14 days)
- Hand expression comprehension(36 weeks gestation)
- Breast feeding self-efficacy(14 days)
- Proportion any breastfeeding(2 months)
- Proportion exclusively breastfeeding(2 months)