Knowledge, Attitudes, PracticeECOFPNCT04020432
Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy
An observational study of Knowledge, Attitudes, Practice and Pregnancy Related, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice, Pregnancy Related
- What is being tested?
- questionary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 281 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2019to 11 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant or childbearing age women between 18 and 45 years old.
Who may be able to join
- women who agree to participate to the study
- women who understand french language (oral and written)
- pregnant women and women of childbearing age from 18 to 45 years old.
Who cannot join
- Women who have already answered the questionnaire
- women who don't want to answer the questionnaire
- women who don't understand french language
- women who are under the age of 18 or over the age of 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge Assessment of Pregnant or Childbearing Age Women About Pictograms Associated With the Danger of Certain Medicines Taken During Pregnancy.
Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder if the meaning of these pictograms is well understood. Therefore, the study's primary aim is to assess the knowledge of pregnant or childbearing age women about the pictograms associated with the danger of certain medicines taken during pregnancy.
- Conditions
- Knowledge, Attitudes, Practice, Pregnancy Related
- Being tested
- questionary
- Keywords
- knowledge, medicine, pictogram, pregnant woman, childbearing age woman
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryBehavioural
A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.
Women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Pregnant women are coming to their monthly consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.
Pregnant women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally. Receives: Behavioral: questionary | |
| childbearing age women | Women of childbearing age, who are coming for a gynecological consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.
Childbearing age women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally. Receives: Behavioral: questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication pictogram women knowledge measure
Determination of women knowledge about pictograms associated with the danger of certain medicines during pregnancy by analysing the questionnaire responses
Measured: day 0
Secondary outcomes (1)
Medication pictogram women information measure
Determination of women information about pictograms associated with the danger of certain medicines during pregnancy by analysing the questionnaire responses
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start11 Jul 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier HIRSON
- Responsible party
- Sponsor
- Investigators
- Alice Rousseaux, Principal investigator, CH Hirson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020432
- Sponsor's protocol ID
- PI2018_843_0042
- Acronym
- ECOFP
- Status last verified
- Mar 2023
- First submitted
- 12 Jul 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Assessment of Pregnant or Childbearing Age Women About Pictograms Associated With the Danger of Certain Medicines Taken During Pregnancy.
- ClinicalTrials.gov ID
- NCT04020432
- Acronym / sponsor ID
- ECOFP / PI2018_843_0042
- Conditions
- Knowledge, Attitudes, Practice, Pregnancy Related
- Keywords
- knowledge, medicine, pictogram, pregnant woman, childbearing age woman
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier HIRSON
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 16 Jul 2019 (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.
Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder if the meaning of these pictograms is well understood. Therefore, the study's primary aim is to assess the knowledge of pregnant or childbearing age women about the pictograms associated with the danger of certain medicines taken during pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Behavioral: questionaryPregnant women are coming to their monthly consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators. Pregnant women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally. |
| childbearing age women | – | Behavioral: questionaryWomen of childbearing age, who are coming for a gynecological consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators. Childbearing age women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant or childbearing age women between 18 and 45 years old.
Key inclusion criteria (3 listed)
- women who agree to participate to the study
- women who understand french language (oral and written)
- pregnant women and women of childbearing age from 18 to 45 years old.
Key exclusion criteria (4 listed)
- Women who have already answered the questionnaire
- women who don't want to answer the questionnaire
- women who don't understand french language
- women who are under the age of 18 or over the age of 45
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 |
|---|---|---|
| questionaryA quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators. Women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally. | Behavioural | childbearing age women, pregnant women |
Primary outcome
Medication pictogram women knowledge measure
Time frame: day 0
Determination of women knowledge about pictograms associated with the danger of certain medicines during pregnancy by analysing the questionnaire responses
1 secondary outcome
Medication pictogram women information measure
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alice Rousseaux principal investigator
CH Hirson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knowledge, Attitudes, Practice and Pregnancy Related, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication pictogram women knowledge measure (time frame: day 0). 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 22 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.