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

Pregnant Women Clinical Trial

— PREVIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105583
• Other study ID #: MC201602
• Status: Completed
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: January 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication and Supplement Use
• Pregnant Women

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication and supplement use among Belgian pregnant women	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	Vitamin deficiencies among Belgian pregnant women	Analysis of a blood sample	One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
Secondary	Medication beliefs among Belgian pregnant women	Beliefs about Medicines Questionnaire (BMQ) (R. Horne, H. Nordeng)	Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age