A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication

Study Overview
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Brief Summary
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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).

Official Title
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A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication

Conditions
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Medication and Supplement Use, Pregnant Women

Intervention / Treatment
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* Drug: Medication use during pregnancy
* Dietary Supplement: Supplement use during pregnancy
* Other: Vitamin status of a pregnant woman


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women visiting the obstetrics department<br> | Drug: Medication use during pregnancy<br> <br> Dietary Supplement: Supplement use during pregnancy<br> <br> Other: Vitamin status of a pregnant woman<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin deficiencies among Belgian pregnant women | Analysis of a blood sample | 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) | Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication beliefs, Information desire, Vitamin deficiencies