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Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium

A Multi-Center Randomized, Parallel-Group Study to Compare Knowledge Translation Between Different Media in Pregnant and Lactating Women

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06863597
Acronym
LACT-ED
Enrollment
380
Registered
2025-03-07
Start date
2025-08-31
Completion date
2027-04-30
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Breastfeeding Education, Breastfeeding Mothers, Lactating Mother, Lactation

Brief summary

Pharmacotherapy for lactating women in Hungary presents a unique challenge. While certain medications may pose risks to the infant or reduce breast milk production, the unnecessary avoidance of treatment can also be harmful. Despite this, no dedicated Hungarian website currently provides guidance on the safe use of over-the-counter (OTC) medications for breastfeeding mothers. To address this gap, the aim is to develop a website that not only meets clinical standards but also presents essential information in a clear, accessible format that helps mothers understand and retain key details by choosing the best medium. Our main question is: What is the most effective way to educate lactating women about OTC medication use through an online platform?

Interventions

OTHERVideo content

Video content produced by media professionals using expert opinions.

OTHERWritten content

Written content produced by healthcare professionals with experience in health education.

OTHERPodcast content

Podcast content created by media experts based on expert opinions.

OTHERIllustration (information leaflet) content

Illustration-based content created by media experts using expert opinions.

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Blinding is not feasible.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Target population is adult (\>18 years), 3rd trimester pregnant women; and breastfeeding women after childbirth (max. 7 days postpartum; 24:00), who intend to breastfeed. * Participants have to have internet access with no regard to the type of internet connection.

Exclusion criteria

* A mother will not breastfeed, either because they cannot or do not want it. * Anyone who do not want to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Knowledge translationFrom enrollment in the first week, followed by an assessment after 6 months.Knowledge translation will be measured by the difference in test scores before and after the intervention. The tests will be developed through common consensus. Since topic-specific tests will be created individually for each topic, only their utility will be assessed in a pilot study, and validation is not planned.

Secondary

MeasureTime frameDescription
User-satisfactionFrom enrollment in the first week, followed by an assessment after 6 months.Questionnaire about user-satisfaction.

Other

MeasureTime frameDescription
Participating mother-specific featuresFrom enrollment in the first week, followed by an assessment after 6 months.The questionnaire addresses topics related to baseline education and other factors that may influence the results.

Contacts

Primary ContactKleiner Dénes, PhD
kleiner.denes@semmelweis.hu+36206164590
Backup ContactDezső Csupor, DSc
csupor.dezso@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026