Evidence map›Paper›PMID 41963694›Full record

ArticleDrug safety2026

Reliability of Self-Reported Maternal Health and Mother-Infant Outcome Data in Web-Based Questionnaires.

Laure Sillis, Laura Van Mechelen, Marleen M H J van Gelder, Sien Lenie, Karel Allegaert, Annick Bogaerts, Maarten De Vos, Titia Hompes, Anne Smits, Kristel Van Calsteren and 3 more

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Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Laure SillisDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. laure.sillis@kuleuven.be.ORCID http://orcid.org/0000-0002-7545-2357
Laura Van MechelenFaculty of Pharmaceutical Sciences, KU Leuven, Leuven, Belgium.
Marleen M H J van GelderIQ Health Science Department, Radboud University Medical Centre, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0003-4853-4434
Sien LenieDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0009-0000-8786-4765
Karel AllegaertDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0001-9921-5105
Annick BogaertsL-C&Y-KU Leuven Child and Youth Institute, Leuven, Belgium.ORCID http://orcid.org/0000-0003-2718-4682
Maarten De VosDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-3482-5145
Titia HompesAdult Psychiatry UPC, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-6206-0389
Anne SmitsL-C&Y-KU Leuven Child and Youth Institute, Leuven, Belgium.ORCID http://orcid.org/0000-0002-0710-6698
Kristel Van CalsterenDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-2438-6783
Jan Y VerbakelDepartment of Public Health and Primary Care, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-7166-7211
Veerle FoulonDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-4053-3915
Michael CeulemansDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-4130-5869

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe BELpREG registry in Belgium collects self-reported real-world data on perinatal medication use and mother-infant outcomes. Given the importance of self-reported data for pregnancy safety studies, this study aims to assess the reliability of maternal health and mother-infant outcome data reported in BELpREG.

methodsWe compared self-reported maternal health and mother-infant outcomes in the BELpREG registry with medical record data from gynaecologists, general practitioners, and midwives. Participants included pregnant women enrolled in BELpREG, aged 18 years or older, who delivered between November 2022 and April 2024 and had medical record data provided by at least one healthcare professional (HCP). Comparisons for continuous variables such as pre-pregnancy body mass index (BMI), gestational age at delivery, and infant metrics at birth were analysed using intraclass correlation coefficients (ICCs). For dichotomous and categorical variables, including pregnancy complications, delivery characteristics, and hospital admissions, we used Cohen's Kappa and observed proportions of positive and negative agreement.

resultsThis study included 175 participants with available medical record data. Medical records were mostly returned by gynaecologists (40%) and midwives (25.7%). Reliability was high for pregnancy complications, onset, and mode of delivery. Gestational age showed almost perfect concordance (ICC 0.99). Infant outcomes, including birth metrics and Apgar scores, were highly reliable (ICC > 0.90), with almost perfect categorisation into birth weight percentiles (Cohen's Kappa 0.97). Self-reported maternal BMI exhibited moderate reliability as a continuous measure (ICC 0.75), but almost perfect agreement when categorised (Cohen's Kappa 0.89). The low prevalence of hospital admissions, delivery complications, infant complications, postpartum complications, and birth defects limited the assessment of these outcomes.

conclusionsThe BELpREG registry demonstrated high agreement between self-reported and HCP-reported data for most maternal health and mother-infant outcomes, supporting its use in future pregnancy safety studies.

Indexed as

Maternal HealthPregnancy OutcomeSelf ReportAdultBelgiumFemaleGestational AgeHumansInfant, NewbornInternetMedical RecordsPregnancyPregnancy ComplicationsRegistriesReproducibility of ResultsSurveys and Questionnaires

Identifiers

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.