Evidence map›Paper›PMID 40980095›Full record

ArticleFrontiers in drug safety and regulation2023

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

Laure Sillis, Veerle Foulon, Karel Allegaert, Annick Bogaerts, Maarten De Vos, Titia Hompes, Anne Smits, Kristel Van Calsteren, Jan Y Verbakel, Michael Ceulemans

Abstract read
In one paragraph

Article in Frontiers in drug safety and regulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Laure SillisClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Veerle FoulonClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Karel AllegaertClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Annick BogaertsLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, Belgium.
Maarten De VosDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Titia HompesLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, Belgium.
Anne SmitsLeuven Child and Youth Institute (L-C&Y), KU Leuven, Leuven, Belgium.
Kristel Van CalsterenDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Jan Y VerbakelDepartment of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Michael CeulemansClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Belgiumdrug informationdrug safetyobservational researchpharmacoepidemiologypharmacovigilancepregnancyregistry

Identifiers

PMID40980095
PMCPMC12443112

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.