A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication (PREVIM)
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|ClinicalTrials.gov Identifier: NCT03105583|
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : January 29, 2019
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).
|Condition or disease||Intervention/treatment|
|Medication and Supplement Use Pregnant Women||Drug: Medication use during pregnancy Dietary Supplement: Supplement use during pregnancy Other: Vitamin status of a pregnant woman|
|Study Type :||Observational|
|Actual Enrollment :||381 participants|
|Official Title:||A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||January 2018|
|Pregnant women visiting the obstetrics department||
Drug: Medication use during pregnancy
Dietary Supplement: Supplement use during pregnancy
Other: Vitamin status of a pregnant woman
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
- 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
- Vitamin deficiencies among Belgian pregnant women [ Time Frame: One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age ]Analysis of a blood sample
- Medication beliefs among Belgian pregnant women [ Time Frame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age ]Beliefs about Medicines Questionnaire (BMQ) (R. Horne, H. Nordeng)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105583
|Principal Investigator:||Veerle Foulon, PhD, PharmD||KU Leuven|