Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorLoma Linda University
About this trial
The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Nulliparous mothers
Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months
Disqualifiers
Mothers planning to use formula
Multiparous mothers who previously breastfed for more than 6 months
Mothers with HIV
Mothers with a history of breast reduction surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Breastfeeding Education
BehavioralFirst meeting will include a pre-test and will go over risks, benefits, and goals for breastfeeding for the mother, baby and family. Second meeting will go over barriers to breastfeeding and the difference between formula and breastmilk. Third visit will include a post-test and go over misconceptions of breastfeeding and the optimal frequency to breastfeed their newborn. Appropriate flyers will be administered at each visit. Congratulatory \& supportive text at birth and 6-week follow up survey will also be administered.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: Breastfeeding EducationExperimental treatment 1 intervention
Group B: PlaceboNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum.
Subjects will complete a Qualtrics survey of 2 questions administered via text message, to determine breastfeeding exclusivity. This survey will be calculated on a Likert scale 0-100. A percentage of 100% will determine exclusive breastfeeding. A percentage of 70-90% represents intermittent breastfeeding. A percentage of less than 70% represents non-exclusive breastfeeding.
Time frame
Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.Secondary outcomes
1
Breastfeeding education pre and post self-efficacy scores of medical students
Assessment of medical student proficiency in breastfeeding management and patient care will be measured using a 25-item multiple-choice questionnaire. The survey evaluates core competencies before and after a structured educational intervention, including the Institute for the Advancement of Breastfeeding and Lactation Education (IABLE) course and a supplemental PowerPoint presentation given by Dr. Elaine Hart. Each question is worth one point, with total scores ranging from 0 to 25; a higher score indicates an increase in breastfeeding knowledge and management competency.
Time frame
Change between baseline through study completion, an average of 1 year.2
Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence.
Assessment of maternal satisfaction with antenatal breastfeeding support, knowledge, motivation, and confidence will be measured using a 13-item questionnaire. The instrument utilizes a combination of 5-point Likert scales to assess self-efficacy and motivation, as well as objective multiple-choice questions to evaluate understanding of breastfeeding benefits, infant output, and clinical management. Knowledge-based items are scored with one point for each correct response, while Likert-scale items are recorded by their selected numerical value (1-5). A higher total composite score represents a longitudinal increase in breastfeeding knowledge, confidence, and motivation from baseline (pre-enrollment) to the 6-week postpartum follow-up.
Time frame
Change between 1st trimester and 6 weeks postpartum.Sponsors and contacts
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Source ClinicalTrials.gov