Pregnant Women Clinical Trial
— PREVIMOfficial title:
A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication
NCT number | NCT03105583 |
Other study ID # | MC201602 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | January 2018 |
Verified date | January 2019 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 381 |
Est. completion date | January 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women who visit the obstetrics department of the University Hospitals of Leuven - =18 years - Able to understand Dutch, French or English Exclusion Criteria: - <18 years - Don't able to understand Dutch, French or English |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
KU Leuven | Universitaire Ziekenhuizen Leuven |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age | |
Secondary | Vitamin deficiencies among Belgian pregnant women | Analysis of a blood sample | One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age | |
Secondary | Medication beliefs among Belgian pregnant women | Beliefs about Medicines Questionnaire (BMQ) (R. Horne, H. Nordeng) | Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age |
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