Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium (LACT-ED)

March 7, 2025 updated by: Semmelweis University

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video content
Participating mothers watch a video on a specific topic.
Other: Video content
Video content produced by media professionals using expert opinions.
Experimental: Written content
Participating mothers read a text about a specific topic.
Other: Written content
Written content produced by healthcare professionals with experience in health education.
Experimental: Podcast content
Participating mothers listen to a podcast on a specific topic.
Other: Podcast content
Podcast content created by media experts based on expert opinions.
Experimental: Illustration (information leaflet) content
Participating mothers view an illustration on a specific topic.
Other: Illustration (information leaflet) content
Illustration-based content created by media experts using expert opinions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment in the first week, followed by an assessment after 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User-satisfaction
Time Frame: From enrollment in the first week, followed by an assessment after 6 months.
Questionnaire about user-satisfaction.
From enrollment in the first week, followed by an assessment after 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment in the first week, followed by an assessment after 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Dénes Kleiner, PhD, Semmelweis University, University Pharmacy Department of Pharmacy Administration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 9/2024
  • BM/26617-3/2024 (Other Identifier: Hungarian Medical Research Council)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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