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Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes

Authors :
Laure Sillis
Veerle Foulon
Karel Allegaert
Annick Bogaerts
Maarten De Vos
Titia Hompes
Anne Smits
Kristel Van Calsteren
Jan Y. Verbakel
Michael Ceulemans
Source :
Frontiers in Drug Safety and Regulation, Vol 3 (2023)
Publication Year :
2023
Publisher :
Frontiers Media S.A., 2023.

Abstract

Although medication use during pregnancy is common, most available products lack sufficient safety information. As prospective data collection and perinatal pharmacoepidemiologic research on medication safety in pregnancy did not exist in Belgium yet, the BELpREG data registration system was developed. BELpREG enables comprehensive “real-world” data collection on perinatal medication use and mother-infant outcomes via online questionnaires that are completed by pregnant women every 4 weeks during pregnancy and in the first 8 weeks after childbirth. This paper describes the development and current design of the BELpREG system, including the list of BELpREG variables. To compile this list of variables, relevant documents were explored, followed by consultation of an interdisciplinary expert panel. The included variables were structured in seven categories: 1) Sociodemographic characteristics; 2) Information on the current pregnancy and health status; 3) Maternal-obstetric history; 4) Use of medicines, folic acid/pregnancy vitamins and other health products; 5) Substance use; 6) Pregnancy outcomes; and 7) Neonatal outcomes. An electronic informed consent and linkage to medication databases, with images of drug packages and underlying structured data fields, are built into the system. Data collection has officially started in November 2022. Based on its rigorous design, BELpREG holds the potential to be a successful and sustainable research tool, enabling perinatal pharmacoepidemiologic research in Belgium and beyond.

Details

Language :
English
ISSN :
26740869
Volume :
3
Database :
Directory of Open Access Journals
Journal :
Frontiers in Drug Safety and Regulation
Publication Type :
Academic Journal
Accession number :
edsdoj.58b3c6591dd0442ca79a0008d94c1cb0
Document Type :
article
Full Text :
https://doi.org/10.3389/fdsfr.2023.1166963