Clinical trial NCT04549129: Prenatal Breastfeeding Education
Official title: First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Feeding
Keywords: Video education
Hand expression of breast milk
Community health center
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

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)

Primary outcomes:
measure: Proportion using hand expression
timeFrame: 3 days post partum
measure: Mean times hand expression in past 24 hours
timeFrame: 3 days post partum
measure: Mean hand expression experience scale
timeFrame: 3 days post partum
Secondary outcomes:
measure: Proportion exclusively breastfeeding
timeFrame: 2 months
measure: Proportion any breastfeeding
timeFrame: 2 months
measure: Breast feeding self-efficacy
timeFrame: 14 days
measure: Proportion with concern for low milk production
timeFrame: 14 days
measure: Hand expression comprehension
timeFrame: 36 weeks gestation
measure: Satisfaction with video
timeFrame: 36 weeks gestation
Other outcomes:
Locations:
city: Quincy
country: United States
facility: Manet Community Health Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Katherine Standish, MD
role: PRINCIPAL_INVESTIGATOR
References: