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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
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Michael Ceulemans, KU Leuven

Brief 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).


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

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Study Type : Observational
Actual Enrollment : 381 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women who visit the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg) will be invited to participate, independent of their pregnancy trimester.

Women can only participate once during their pregnancy.

Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
KU Leuven
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Veerle Foulon, PhD, PharmD KU Leuven
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Responsible Party: Michael Ceulemans, Pharm D - PhD Researcher, KU Leuven
ClinicalTrials.gov Identifier: NCT03105583    
Other Study ID Numbers: MC201602
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Ceulemans, KU Leuven:
Medication beliefs
Information desire
Vitamin deficiencies
Additional relevant MeSH terms:
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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs