Evidence map›Paper›PMID 33970448›Full record

ArticleDrug safety2021

Risk of Pregnancy Termination and Congenital Anomalies After Domperidone Exposure: A Study in the EFEMERIS Database.

Mélanie Araujo, Clémentine Vabre, Justine Benevent, Agnès Sommet, Christine Damase-Michel, Caroline Hurault-Delarue, Isabelle Lacroix

Abstract read
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In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
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

7 authors at 1 institution in 1 country.

Mélanie AraujoRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France. araujo.m@chu-toulouse.fr.ORCID 0000-0003-3057-9554
Clémentine VabreRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Justine BeneventRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Agnès SommetRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), CIC 1436, Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Christine Damase-MichelRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Caroline Hurault-DelarueRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Isabelle LacroixRéseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Université Toulouse III - Paul Sabatier · FR

Funding

ANDROGEN REGULATION OF HUMAN SEBACEOUS GLANDSK08AR002018 · NIAMS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI THIBOUTOT, DIANE M. · 1997 to 2001
$225k
6 · The paper itself

Abstract

introductionDomperidone is widely used during pregnancy, although the risks associated with pregnant women have not been adequately evaluated.

objectiveThe objective of this study was to compare the rate of pregnancy outcomes and congenital anomalies between pregnant women exposed and unexposed to domperidone during pregnancy.

methodsWe conducted a retrospective cohort study comparing pregnant women exposed and unexposed to domperidone during pregnancy. We used the EFEMERIS database containing the prescriptions and dispensing of drugs to pregnant women in Haute-Garonne, who had a pregnancy outcome between July 2004 and December 2017. We compared pregnant women who were exposed to domperidone at least once during pregnancy to unexposed pregnant women. Logistic regression and Cox proportional risk models were applied.

resultsOverall, 13,964 pregnancies (10.3% of pregnancies) were given domperidone. A reduction in the number of pregnant women exposed to domperidone (2004: 17.1% to 2017: 1.2%) was noted. More than 75% of pregnancies were exposed to domperidone in the first trimester of pregnancy. The rate of natural pregnancy termination in pregnant women exposed to domperidone was lower than that in unexposed pregnant women (adjusted hazard ratio = 0.78 [0.71-0.87]). The malformation rate in fetuses/newborns exposed in utero (first trimester) to domperidone is comparable to that of unexposed fetuses/newborns (adjusted odd ratio = 0.89 [0.77-1.03]).

conclusionsThis is the first comparative study to enrol a large number of pregnant women exposed to domperidone. Data regarding the malformation rate following exposure to domperidone during the first trimester of pregnancy are reassuring. Women exposed to domperidone during pregnancy have a decreased risk for natural pregnancy termination, probably owing to an indication bias.

Indexed as

Abnormalities, Drug-InducedAbortion, InducedDomperidoneFemaleHumansInfant, NewbornPregnancyPregnancy OutcomePregnancy Trimester, FirstRetrospective StudiesDomperidone

Identifiers

PMID33970448
OpenAlexW3161619051

What OpenQuestion holds

Textmetadata
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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.