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

NCT03105583 — Completed, 381 participants, KU Leuven
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RegistryNCT03105583, acronym PREVIM
StatusCompleted
Study typeObservational
Enrollment381 (Actual)
SponsorKU Leuven (Other); collaborators: Universitaire Ziekenhuizen KU Leuven
ConditionsMedication and Supplement Use, Pregnant Women
InterventionsMedication use during pregnancy, Supplement use during pregnancy, Vitamin status of a pregnant woman (Drug, dietary supplement, other)
Datesstart 2016-12-01, primary completion 2017-04-01, completion 2018-01-01, first posted 2017-04-10, last updated 2019-01-29

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-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 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).

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Pregnant women visiting the obstetrics departmentDrug: Medication use during pregnancy; Dietary Supplement: Supplement use during pregnancy; Other: Vitamin status of a pregnant woman
  • Medication use during pregnancy (Drug)
  • Supplement use during pregnancy (Dietary supplement)
  • Vitamin status of a pregnant woman (Other): 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

+Outcome measures

Primary outcomes

  • Medication and supplement use among Belgian pregnant women [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

Secondary outcomes

  • Vitamin deficiencies among Belgian pregnant women [One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age]: Analysis of a blood sample
  • Medication beliefs among Belgian pregnant women [Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age]: Beliefs about Medicines Questionnaire (BMQ) (R. Horne, H. Nordeng)

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Investigators

My Notes