Prenatal Breastfeeding Education

First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education

Sponsors

Lead Sponsor: Boston Medical Center

Source Boston Medical Center
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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date December 2021
Primary Completion Date October 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion using hand expression 3 days post partum
Mean times hand expression in past 24 hours 3 days post partum
Mean hand expression experience scale 3 days post partum
Secondary Outcome
Measure Time Frame
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
Satisfaction with video 36 weeks gestation
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Breastfeeding education video

Description: 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).

Arm Group Label: Intervention group

Intervention Type: Behavioral

Intervention Name: Breastfeeding website

Description: 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).

Arm Group Label: Intervention group

Intervention Type: Behavioral

Intervention Name: Usual breastfeed education

Description: The usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice

Arm Group Label: Control group

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)

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Katherine Standish, MD Principal Investigator Boston Medical Center
Overall Contact

Last Name: Katherine Standish, MD

Phone: 617-414-6324

Email: [email protected]

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Intervention group

Type: Experimental

Description: 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.

Label: Control group

Type: Active Comparator

Description: Participants randomized to the control group will receive usual breastfeeding education during their 36-week visit.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov