By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.
Objectives
The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.
Methods
This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.
Results
All REMEDIES criteria (n = 104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.
Conclusions
One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.
{"title":"Translation of the REMEDI[e]S (Review of potentially inappropriate MEDIcation pr[e]scribing in Seniors) explicit criteria into seminatural language for use in prescription support systems: A multidisciplinary consensus","authors":"Romane Freppel , Anaïs Barbier , Mathilde Dambrine , Laurine Robert , Chloé Rousselière , Estel Cuneo , Pascal Odou , Sophie Gautier , Jean-Baptiste Beuscart , Marie-Laure Laroche , Bertrand Décaudin","doi":"10.1016/j.therap.2024.09.002","DOIUrl":"10.1016/j.therap.2024.09.002","url":null,"abstract":"<div><h3>Background</h3><div>By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.</div></div><div><h3>Objectives</h3><div>The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.</div></div><div><h3>Methods</h3><div>This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.</div></div><div><h3>Results</h3><div>All REMEDIES criteria (<em>n</em> <!-->=<!--> <!-->104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.</div></div><div><h3>Conclusions</h3><div>One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 477-493"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2025.02.012
Annie-Pierre Jonville-Bera , Joëlle Micallef
Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à Streptococcus pyogenes sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.
For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by Streptococcus pyogenes or Pneumococcus after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, ple
{"title":"Impact délétère d’un anti-inflammatoire non stéroïdien pris pour fièvre ou douleur aiguë en cas d’infection streptococcique","authors":"Annie-Pierre Jonville-Bera , Joëlle Micallef","doi":"10.1016/j.therap.2025.02.012","DOIUrl":"10.1016/j.therap.2025.02.012","url":null,"abstract":"<div><div>Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à <em>Streptococcus pyogenes</em> sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.</div></div><div><div>For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by <em>Streptococcus pyogenes</em> or <em>Pneumococcus</em> after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, ple","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 424-428"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.
Méthodes
Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.
Résultats
Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (n = 2 à M0 et n = 10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24 heures a été multiplié par 2 (n = 2 à M0 et n = 4 à M3).
Conclusion
Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.
Objective
A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.
Method
A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.
{"title":"Impact d’une rupture de dronabinol sur une population de patients douloureux chroniques : étude observationnelle rétrospective","authors":"Salomé Winckel, Laurie Ferret, Laure Dujardin, Amélie Boursier","doi":"10.1016/j.therap.2024.12.010","DOIUrl":"10.1016/j.therap.2024.12.010","url":null,"abstract":"<div><h3>Objectif</h3><div>Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.</div></div><div><h3>Méthodes</h3><div>Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.</div></div><div><h3>Résultats</h3><div>Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24<!--> <!-->heures a été multiplié par 2 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->4 à M3).</div></div><div><h3>Conclusion</h3><div>Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.</div></div><div><h3>Objective</h3><div>A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.</div></div><div><h3>Method</h3><div>A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.</div></div><div><h3>Results</h3><div>Health deterioration was repo","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 469-476"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-26DOI: 10.1016/j.therap.2025.06.004
Tristan Pillot, Anas Gahbiche, Xavier Duval, Vanessa Bloch, Aude Jacob
Objectives: The field of clinical research is continuously developing in healthcare institutions in France. However, this development should not come at the expense of the quality of studies or the safety of patients involved in research projects. Describe the certification process of the pharmaceutical clinical trials unit of Lariboisière hospital-Fernand Widal's (unité pharmaceutique des essais cliniques de l'hôpital Lariboisière-Fernand Widal UPEC) quality management system according to the ISO 9001: 2015 standard for the continuous improvement of quality.
Methods: This certification project, initiated by the medical-university department to which UPEC belongs, was led by a quality assurance officer, supported by a quality consultant, and carried out by the members of the UPEC team. An initial audit provided a status report, and a planning schedule structured the entire process by setting deadlines.
Results: Obtained in September 2023, the certification for the pharmaceutical management of investigational products in our sector was achieved by identifying internal and external issues, interested parties, and the risks and opportunities related to UPEC's activities. Additionally, the development of relevant monitoring indicators allows for the evaluation of the quality systems management's (QMS) effectiveness. Finally, the prioritization of actions based on the conclusions of the initial audit report enabled effective progress, resulting in a QMS compliant with the ISO 9001: 2015 standard within 21 months.
Conclusions: Thus, obtaining the certification represents a tremendous experience, the culmination of the substantial work provided by the entire team, and an external recognition that is beneficial for the development of the activity through future partnerships.
目的:临床研究领域在法国的医疗机构中不断发展。然而,这种发展不应以牺牲研究质量或参与研究项目的患者的安全为代价。描述lariboisi医院- fernand Widal (unit pharmaceutique des essais cliniques de l'hôpital lariboisi - fernand Widal UPEC)药物临床试验单元根据ISO 9001: 2015标准进行质量持续改进的质量管理体系认证过程。方法:本认证项目由UPEC所属医科大学系发起,由一名质量保证官员领导,一名质量顾问支持,由UPEC团队成员执行。最初的审计提供了一份状态报告,计划进度表通过设定截止日期来组织整个过程。结果:通过识别与UPEC活动相关的内部和外部问题、利益相关方以及风险和机会,我们于2023年9月获得了本部门临床试验产品药品管理认证。此外,相关监控指标的制定允许对质量体系管理(QMS)的有效性进行评价。最后,基于初始审核报告结论的行动优先级使有效进展成为可能,从而在21个月内实现了符合ISO 9001: 2015标准的质量管理体系。结论:因此,获得认证代表了一种巨大的经验,是整个团队提供的大量工作的高潮,也是一种外部认可,有利于通过未来的合作伙伴关系发展这项活动。
{"title":"[ISO 9001: 2015 certification of the clinical trial unit of a university hospital center].","authors":"Tristan Pillot, Anas Gahbiche, Xavier Duval, Vanessa Bloch, Aude Jacob","doi":"10.1016/j.therap.2025.06.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.004","url":null,"abstract":"<p><strong>Objectives: </strong>The field of clinical research is continuously developing in healthcare institutions in France. However, this development should not come at the expense of the quality of studies or the safety of patients involved in research projects. Describe the certification process of the pharmaceutical clinical trials unit of Lariboisière hospital-Fernand Widal's (unité pharmaceutique des essais cliniques de l'hôpital Lariboisière-Fernand Widal UPEC) quality management system according to the ISO 9001: 2015 standard for the continuous improvement of quality.</p><p><strong>Methods: </strong>This certification project, initiated by the medical-university department to which UPEC belongs, was led by a quality assurance officer, supported by a quality consultant, and carried out by the members of the UPEC team. An initial audit provided a status report, and a planning schedule structured the entire process by setting deadlines.</p><p><strong>Results: </strong>Obtained in September 2023, the certification for the pharmaceutical management of investigational products in our sector was achieved by identifying internal and external issues, interested parties, and the risks and opportunities related to UPEC's activities. Additionally, the development of relevant monitoring indicators allows for the evaluation of the quality systems management's (QMS) effectiveness. Finally, the prioritization of actions based on the conclusions of the initial audit report enabled effective progress, resulting in a QMS compliant with the ISO 9001: 2015 standard within 21 months.</p><p><strong>Conclusions: </strong>Thus, obtaining the certification represents a tremendous experience, the culmination of the substantial work provided by the entire team, and an external recognition that is beneficial for the development of the activity through future partnerships.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-25DOI: 10.1016/j.therap.2025.06.005
Romain Batton, Fabien Lamoureux, Marion Beuzelin, Jean-Philippe Rigaud, Antoine Marchalot
{"title":"[Case report of a lethal voluntary drug intoxication with mirtazapine and venlafaxine complicated with a massive pharmacobezoar].","authors":"Romain Batton, Fabien Lamoureux, Marion Beuzelin, Jean-Philippe Rigaud, Antoine Marchalot","doi":"10.1016/j.therap.2025.06.005","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-23DOI: 10.1016/j.therap.2025.06.003
Marlène Damin-Pernik, Emilie Mayer, Anne Dautriche, Laure Mazzola, Marie-Noelle Beyens, Elisabeth Botelho-Nevers
{"title":"Preventing the risk of tuberculosis with teriflunomide: Is pre-treatment screening necessary?","authors":"Marlène Damin-Pernik, Emilie Mayer, Anne Dautriche, Laure Mazzola, Marie-Noelle Beyens, Elisabeth Botelho-Nevers","doi":"10.1016/j.therap.2025.06.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144601698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and vaccination COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few ‘serious’ adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.
{"title":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy","authors":"Isabelle Lacroix , Anthony Caillet , Laurane Delteil , Hadjer Ameur , Nassima Padelli , Caroline Hurault-Delarue , Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"10.1016/j.therap.2024.06.003","url":null,"abstract":"<div><div><span><span>The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the </span>health status<span><span> of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported </span>adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and </span></span>vaccination<span> COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few ‘serious’ adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension<span><span> and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened </span>preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.</span></span></div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 271-278"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}