Breastfeeding EducationLACT-EDNCT06863597
Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium
A study testing Video content, Written content and Podcast content in people with Breastfeeding Education and Lactating Mother, run by Semmelweis University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education, Lactating Mother, Breastfeeding Mothers
- What is being tested?
- Video content, Written content and Podcast content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A mother will not breastfeed, either because they cannot or do not want it.
- Anyone who do not want to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dezső Csupor, DSc contact
About this study
Official title: A Multi-Center Randomized, Parallel-Group Study to Compare Knowledge Translation Between Different Media in Pregnant and Lactating Women
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?
- Conditions
- Breastfeeding Education, Lactating Mother, Breastfeeding Mothers, Lactation, Breastfeeding
- Being tested
- Video content, Written content, Podcast content, Illustration (information leaflet) content
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video contentOther
Video content produced by media professionals using expert opinions.
Written contentOther
Written content produced by healthcare professionals with experience in health education.
Podcast contentOther
Podcast content created by media experts based on expert opinions.
Illustration (information leaflet) contentOther
Illustration-based content created by media experts using expert opinions.
| Study group | Role | What they receive |
|---|---|---|
| Video content | Experimental | Participating mothers watch a video on a specific topic. Receives: Other: Video content |
| Written content | Experimental | Participating mothers read a text about a specific topic. Receives: Other: Written content |
| Podcast content | Experimental | Participating mothers listen to a podcast on a specific topic. Receives: Other: Podcast content |
| Illustration (information leaflet) content | Experimental | Participating mothers view an illustration on a specific topic. Receives: Other: Illustration (information leaflet) content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment in the first week, followed by an assessment after 6 months.
Secondary outcomes (1)
User-satisfaction
Questionnaire about user-satisfaction.
Measured: From enrollment in the first week, followed by an assessment after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startAug 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding EducationStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dénes Kleiner, PhD, Principal investigator, Semmelweis University, University Pharmacy Department of Pharmacy Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863597
- Sponsor's protocol ID
- 9/2024
- Other IDs
- BM/26617-3/2024
- Acronym
- LACT-ED
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Parallel-Group Study to Compare Knowledge Translation Between Different Media in Pregnant and Lactating Women
- ClinicalTrials.gov ID
- NCT06863597
- Acronym / sponsor ID
- LACT-ED / 9/2024
- Conditions
- Breastfeeding Education, Lactating Mother, Breastfeeding Mothers, Lactation, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video content | Experimental | Other: Video contentParticipating mothers watch a video on a specific topic. |
| Written content | Experimental | Other: Written contentParticipating mothers read a text about a specific topic. |
| Podcast content | Experimental | Other: Podcast contentParticipating mothers listen to a podcast on a specific topic. |
| Illustration (information leaflet) content | Experimental | Other: Illustration (information leaflet) contentParticipating mothers view an illustration on a specific topic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- A mother will not breastfeed, either because they cannot or do not want it.
- Anyone who do not want to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video contentVideo content produced by media professionals using expert opinions. | Other | Video content |
| Written contentWritten content produced by healthcare professionals with experience in health education. | Other | Written content |
| Podcast contentPodcast content created by media experts based on expert opinions. | Other | Podcast content |
| Illustration (information leaflet) contentIllustration-based content created by media experts using expert opinions. | Other | Illustration (information leaflet) content |
Primary outcome
Knowledge translation
Time frame: From 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.
1 secondary outcome
User-satisfaction
Time frame: From enrollment in the first week, followed by an assessment after 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Related trials for Breastfeeding Education
Enrolling by invitation
The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels
Breastfeeding, Postpartum Comfort
Recruiting
Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
Not yet recruiting
Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
Not yet recruiting
The Effect of Model-based Education on Breastfeeding Self-efficacy and Success
Breastfeeding
Not yet recruiting
Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction
Breastfeeding Attitudes, Breast Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dezső Csupor, DSc contact
Dénes Kleiner, PhD principal investigator
Semmelweis University, University Pharmacy Department of Pharmacy Administration
Questions about this trial
What is this clinical trial studying?
A study testing Video content, Written content and Podcast content in people with Breastfeeding Education and Lactating Mother, run by Semmelweis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kleiner Dénes, PhD (+36206164590, kleiner.denes@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge translation (time frame: From enrollment in the first week, followed by an assessment after 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.