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NCT Number: NCT06863597

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

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?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video content

Other

Video content produced by media professionals using expert opinions.

Written content

Other

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

Podcast content

Other

Podcast content created by media experts based on expert opinions.

Illustration (information leaflet) content

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. User-satisfaction

    Time frame: From enrollment in the first week, followed by an assessment after 6 months.

    Questionnaire about user-satisfaction.

Other outcomes

  1. Participating mother-specific features

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dezső Csupor, DSc

CONTACT

[email protected]

Kleiner Dénes, PhD

CONTACT

[email protected]

+36206164590

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Acronym: LACT-ED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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