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

January 28, 2019 updated by: Michael Ceulemans, KU Leuven

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
Analysis of a blood sample
One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
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)
Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Veerle Foulon, PhD, PharmD, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

April 3, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC201602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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