Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium
LACT-ED
A Multi-Center Randomized, Parallel-Group Study to Compare Knowledge Translation Between Different Media in Pregnant and Lactating Women
2 other identifiers
interventional
380
0 countries
N/A
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
March 11, 2025
February 1, 2025
1.7 years
March 3, 2025
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Knowledge translation
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.
From enrollment in the first week, followed by an assessment after 6 months.
Secondary Outcomes (1)
User-satisfaction
From enrollment in the first week, followed by an assessment after 6 months.
Other Outcomes (1)
Participating mother-specific features
From enrollment in the first week, followed by an assessment after 6 months.
Study Arms (4)
Video content
EXPERIMENTALParticipating mothers watch a video on a specific topic.
Written content
EXPERIMENTALParticipating mothers read a text about a specific topic.
Podcast content
EXPERIMENTALParticipating mothers listen to a podcast on a specific topic.
Illustration (information leaflet) content
EXPERIMENTALParticipating mothers view an illustration on a specific topic.
Interventions
Written content produced by healthcare professionals with experience in health education.
Podcast content created by media experts based on expert opinions.
Illustration-based content created by media experts using expert opinions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A mother will not breastfeed, either because they cannot or do not want it.
- Anyone who do not want to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dénes Kleiner, PhD
Semmelweis University, University Pharmacy Department of Pharmacy Administration
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Blinding is not feasible.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 7, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
March 11, 2025
Record last verified: 2025-02