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Completed

NCT Number: NCT03105583

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

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).

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Key information

Conditions

Medication and Supplement Use Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pregnant Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Acronym: PREVIM

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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