Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes
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 develop...
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Frontiers Media S.A.
2023-05-01
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| Series: | Frontiers in Drug Safety and Regulation |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1166963/full |
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| author | Laure Sillis Laure Sillis Laure Sillis Veerle Foulon Veerle Foulon Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Annick Bogaerts Annick Bogaerts Annick Bogaerts Maarten De Vos Maarten De Vos Titia Hompes Titia Hompes Titia Hompes Anne Smits Anne Smits Anne Smits Kristel Van Calsteren Kristel Van Calsteren Jan Y. Verbakel Jan Y. Verbakel Michael Ceulemans Michael Ceulemans Michael Ceulemans |
| author_facet | Laure Sillis Laure Sillis Laure Sillis Veerle Foulon Veerle Foulon Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Annick Bogaerts Annick Bogaerts Annick Bogaerts Maarten De Vos Maarten De Vos Titia Hompes Titia Hompes Titia Hompes Anne Smits Anne Smits Anne Smits Kristel Van Calsteren Kristel Van Calsteren Jan Y. Verbakel Jan Y. Verbakel Michael Ceulemans Michael Ceulemans Michael Ceulemans |
| author_sort | Laure Sillis |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-58b3c6591dd0442ca79a0008d94c1cb0 |
| institution | OA Journals |
| issn | 2674-0869 |
| language | English |
| publishDate | 2023-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Drug Safety and Regulation |
| spelling | doaj-art-58b3c6591dd0442ca79a0008d94c1cb02025-08-20T02:32:44ZengFrontiers Media S.A.Frontiers in Drug Safety and Regulation2674-08692023-05-01310.3389/fdsfr.2023.11669631166963Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomesLaure Sillis0Laure Sillis1Laure Sillis2Veerle Foulon3Veerle Foulon4Karel Allegaert5Karel Allegaert6Karel Allegaert7Karel Allegaert8Annick Bogaerts9Annick Bogaerts10Annick Bogaerts11Maarten De Vos12Maarten De Vos13Titia Hompes14Titia Hompes15Titia Hompes16Anne Smits17Anne Smits18Anne Smits19Kristel Van Calsteren20Kristel Van Calsteren21Jan Y. Verbakel22Jan Y. Verbakel23Michael Ceulemans24Michael Ceulemans25Michael Ceulemans26Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumResearch Foundation Flanders (FWO), Brussels, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumDepartment of Clinical Pharmacy, Erasmus MC, Rotterdam, NetherlandsLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumFaculty of Health, University of Plymouth, Devon, United KingdomDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumDepartment of Electrical Engineering (ESAT), KU Leuven, Leuven, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumAdult Psychiatry UPC, KU Leuven, Leuven, BelgiumDepartment of Neurosciences, KU Leuven, Leuven, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium0Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium1Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium2Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium3Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United KingdomClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, Belgium4Teratology Information Service, Pharmacovigilance Centre Lareb, 's Hertogenbosch, NetherlandsAlthough 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.https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1166963/fullpregnancydrug informationdrug safetypharmacovigilancepharmacoepidemiologyregistry |
| spellingShingle | Laure Sillis Laure Sillis Laure Sillis Veerle Foulon Veerle Foulon Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Annick Bogaerts Annick Bogaerts Annick Bogaerts Maarten De Vos Maarten De Vos Titia Hompes Titia Hompes Titia Hompes Anne Smits Anne Smits Anne Smits Kristel Van Calsteren Kristel Van Calsteren Jan Y. Verbakel Jan Y. Verbakel Michael Ceulemans Michael Ceulemans Michael Ceulemans Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes Frontiers in Drug Safety and Regulation pregnancy drug information drug safety pharmacovigilance pharmacoepidemiology registry |
| title | Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes |
| title_full | Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes |
| title_fullStr | Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes |
| title_full_unstemmed | Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes |
| title_short | Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes |
| title_sort | development and design of the belpreg registration system for the collection of real world data on medication use in pregnancy and mother infant outcomes |
| topic | pregnancy drug information drug safety pharmacovigilance pharmacoepidemiology registry |
| url | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1166963/full |
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