Evidence map›Paper›PMID 32513880›Full record

ArticleBMJ open2020

Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study.

Pierre-Olivier Blotière, Sara Miranda, Alain Weill, Yann Mikaeloff, Hugo Peyre, Franck Ramus, Zureik Mahmoud, Joël Coste, Rosemary Dray-Spira

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
13.1field-weighted citation impact, top 1% of its field
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

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.

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  6. Associations between maternal sleep disorders and long-term neurodevelopmental disorders in children: evidence from a national cohort of 1.9 million births.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
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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

9 authors at 6 institutions in 1 country.

Pierre-Olivier BlotièreDepartment of Public Health Studies, French National Health Insurance (CNAM), Paris, France poblotiere@gmail.com.ORCID 0000-0002-6857-6781
Sara MirandaDepartment of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, Saint-Denis, France.
Alain WeillDepartment of Public Health Studies, French National Health Insurance (CNAM), Paris, France.
Yann MikaeloffAssistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Unité de Rééducation Neurologique Infantile, Bicêtre, France.
Hugo PeyreLaboratoire de Sciences Cognitives et Psycholinguistique, Ecole Normale Supérieure, EHESS, CNRS, PSL University, Paris, France.
Franck RamusLaboratoire de Sciences Cognitives et Psycholinguistique, Ecole Normale Supérieure, EHESS, CNRS, PSL University, Paris, France.
Zureik MahmoudDepartment of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, Saint-Denis, France.
Joël CosteDepartment of Public Health Studies, French National Health Insurance (CNAM), Paris, France.
Rosemary Dray-SpiraDepartment of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, Saint-Denis, France.ORCID 0000-0001-7646-3667
Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail · FRCentre National de la Recherche Scientifique · FRConservatoire National des Arts et Métiers · FRDélégation Paris 5 · FRUniversité de Versailles Saint-Quentin-en-Yvelines · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the association between prenatal exposure to monotherapy with the antiepileptic drugs (AEDs) most commonly used during pregnancy and the risk of various neurodevelopmental outcomes compared with lamotrigine.

designNationwide population-based cohort study.

settingFrench national healthcare databases.

participantsChildren born alive between 2011 and 2014 and prenatally exposed to AED monotherapy. PRIMARY AND SECONDARY OUTCOME MEASURES: Outcomes included neurodevelopmental disorders (NDD), defined by International Classification of Diseases, 10th Revision codes F70-F98-pervasive developmental disorders (PDD, F84) and mental retardation (MR, F70-F79) were studied separately-and visits to speech therapists. The reference group comprised children prenatally exposed to lamotrigine. Children were followed until outcome, loss to follow-up, death or 31 December 2016. We performed inverse probability of treatment weighting analyses using the propensity score, which included maternal and infant characteristics. Hazard ratios (HRs) were calculated using Cox models.

resultsThe cohort comprised 9034 children, 2916 of which were exposed to lamotrigine, 1627 to pregabalin, 1246 to clonazepam, 991 to valproic acid (VPA), 621 to levetiracetam, 502 to carbamazepine, 477 to topiramate, 378 to gabapentin and 143 to oxcarbazepine. None of these AEDs, except VPA, was associated with an increased risk of any of the four neurodevelopmental outcomes investigated. Exposure to VPA was associated with increased risks of NDDs (HR=2.7, 95% CI (1.8 to 4.0)), PDD (HR=4.4 (2.1 to 9.3)), MR (HR=3.1 (1.5 to 6.2)) and visits to speech therapists (HR=1.5 (1.1 to 1.9)), with a dose-response relationship.

conclusionsNo increased risk of any of the neurodevelopmental outcomes investigated in this study was observed with prenatal exposure to levetiracetam, pregabalin, oxcarbazepine, topiramate, gabapentin, clonazepam or carbamazepine, compared with lamotrigine. However, this study corroborates the well-known association between maternal use of VPA during pregnancy and the risk of neurodevelopmental disorders in the offspring. Longer follow-up is necessary to confirm these findings.

Indexed as

AnticonvulsantsChildChild Development Disorders, PervasiveChild, PreschoolCohort StudiesDatabases, FactualFemaleFranceHumansMalePregnancyPrenatal Exposure Delayed EffectsValproic AcidAnticonvulsantsValproic Acidchild & adolescent psychiatryepilepsypaediatric neurology

Identifiers

PMID32513880
PMCPMC7282331
OpenAlexW3033513110

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.