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

Completed

• Conditions: Pregnant Women; Medication and Supplement Use
• Interventions: Drug: Medication use during pregnancy; Dietary Supplement: Supplement use during pregnancy; Other: Vitamin status of a pregnant woman

• Registration Number: NCT03105583
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-08
• Study Start: 2016-12
• Primary Completion: 2017-04
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Study Completion: 2018-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 381

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women visiting the obstetrics department	Supplement use during pregnancy	-
Pregnant women visiting the obstetrics department	Vitamin status of a pregnant woman	-
Pregnant women visiting the obstetrics department	Medication use during pregnancy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Vitamin deficiencies among Belgian pregnant women	One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age	Analysis of a blood sample