Medication and Supplement UsePREVIMNCT03105583
A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication
An observational study of Medication and Supplement Use and Pregnant Women, run by KU Leuven.
Trial summary
This cross-sectional study will try to give answers to the following project aims: To provide an overview of the prevalence of health products' use among Belgian pregnant women (prescription and OTC medication, vitamin supplements, phyto-therapeutics, dermatologic products), including where pregnant women buy or get… 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
- Medication and Supplement Use, Pregnant Women
- What is being tested?
- Medication use during pregnancy, Supplement use during pregnancy and Vitamin status of a pregnant woman
- How many people
- 381 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women who visit the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg) will be invited to participate, independent of their pregnancy trimester. Women can only participate once during their pregnancy.
Who may be able to join
- Pregnant women who visit the obstetrics department of the University Hospitals of Leuven
- ≥18 years
- Able to understand Dutch, French or English
Who cannot join
- <18 years
- Don't able to understand Dutch, French or English
About this study
This cross-sectional study will try to give answers to the following project aims:
- To provide an overview of the prevalence of health products' use among Belgian pregnant women (prescription and OTC medication, vitamin supplements, phyto-therapeutics, dermatologic products), including where pregnant women buy or get their health products (online web survey).
- To document women's beliefs about medication during pregnancy and their information desire (online web survey).
- To determine the current vitamin status among pregnant women and to reveal clinical targets for supplementing deficiencies in this population (blood sample analysis).
Read more
The study will be performed at the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg).
We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to determine their vitamin status (50 per trimester).
- Conditions
- Medication and Supplement Use, Pregnant Women
- Being tested
- Medication use during pregnancy, Supplement use during pregnancy, Vitamin status of a pregnant woman
- Keywords
- Medication beliefs, Information desire, Vitamin deficiencies
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication use during pregnancyDrug
Supplement use during pregnancyDietary supplement
Vitamin status of a pregnant womanOther
Haemoglobin, RBC count + hematocrits, thrombocytes count, folate (serum), vitamin B12, WBC count, ferritin, iron (serum), transferrin % and saturation, TSH, T4, free glucose, LDH, ALT, AST, GGT, bilirubin (total), CRP, albumin, total protein, ureum, uric acid, creating, calcium (total), 25-hydroxy vitamin D, Na, K, Mg
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women visiting the obstetrics department | Not described Receives: Drug: Medication use during pregnancy; Dietary Supplement: Supplement use during pregnancy; Other: Vitamin status of a pregnant woman |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication and supplement use among Belgian pregnant women
Percentage of women who have taken a health product during the last 7 days - Overview of the health products used by pregnant women
Measured: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
Secondary outcomes (2)
Vitamin deficiencies among Belgian pregnant women
Analysis of a blood sample
Measured: One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
Medication beliefs among Belgian pregnant women
Beliefs about Medicines Questionnaire (BMQ) (R. Horne, H. Nordeng)
Measured: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startDec 2016
- Primary completionApr 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication and Supplement UseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Michael Ceulemans, KU Leuven
- Investigators
- Veerle Foulon, PhD, PharmD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105583
- Sponsor's protocol ID
- MC201602
- Acronym
- PREVIM
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication
- ClinicalTrials.gov ID
- NCT03105583
- Acronym / sponsor ID
- PREVIM / MC201602
- Conditions
- Medication and Supplement Use, Pregnant Women
- Keywords
- Medication beliefs, Information desire, Vitamin deficiencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 10 Apr 2017 (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.
This cross-sectional study will try to give answers to the following project aims:
- To provide an overview of the prevalence of health products' use among Belgian pregnant women (prescription and OTC medication, vitamin supplements, phyto-therapeutics, dermatologic products), including where pregnant women buy or get their health products (online web survey).
- To document women's beliefs about medication during pregnancy and their information desire (online web survey).
- To determine the current vitamin status among pregnant women and to reveal clinical targets for supplementing deficiencies in this population (blood sample analysis).
The study will be performed at the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg).
We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to determine their vitamin status (50 per trimester).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women visiting the obstetrics department | – | Drug: Medication use during pregnancy, Dietary Supplement: Supplement use during pregnancy, Other: Vitamin status of a pregnant woman |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who visit the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg) will be invited to participate, independent of their pregnancy trimester. Women can only participate once during their pregnancy.
Key inclusion criteria (3 listed)
- Pregnant women who visit the obstetrics department of the University Hospitals of Leuven
- ≥18 years
- Able to understand Dutch, French or English
Key exclusion criteria (2 listed)
- <18 years
- Don't able to understand Dutch, French or English
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 |
|---|---|---|
| Medication use during pregnancy | Drug | Pregnant women visiting the obstetrics department |
| Supplement use during pregnancy | Dietary supplement | Pregnant women visiting the obstetrics department |
| Vitamin status of a pregnant womanHaemoglobin, RBC count + hematocrits, thrombocytes count, folate (serum), vitamin B12, WBC count, ferritin, iron (serum), transferrin % and saturation, TSH, T4, free glucose, LDH, ALT, AST, GGT, bilirubin (total), CRP, albumin, total protein, ureum, uric acid, creating, calcium (total), 25-hydroxy vitamin D, Na, K, Mg | Other | Pregnant women visiting the obstetrics department |
Primary outcome
Medication and supplement use among Belgian pregnant women
Time frame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
Percentage of women who have taken a health product during the last 7 days - Overview of the health products used by pregnant women
2 secondary outcomes
Vitamin deficiencies among Belgian pregnant women
Time frame: One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
Medication beliefs among Belgian pregnant women
Time frame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
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 29 Jan 2019.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Veerle Foulon, PhD, PharmD principal investigator
KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Medication and Supplement Use and Pregnant Women, run by KU Leuven.
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 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: finished, as of the sponsor's last update on 29 Jan 2019. 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?
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 and supplement use among Belgian pregnant women (time frame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age). 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 29 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.