Abbonarsi

COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy - 21/05/25

Doi : 10.1016/j.therap.2024.06.003 
Isabelle Lacroix a, Anthony Caillet a, Laurane Delteil a, Hadjer Ameur b, Nassima Padelli a, Caroline Hurault-Delarue a, Judith Cottin b,
a Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse, 31000 Toulouse, France 
b Service hospitalo-universitaire de pharmacotoxicologie, centre régional de pharmacovigilance, hospices civils de Lyon, 162, avenue Lacassagne, 69424 Lyon cedex 03, France 

Corresponding author. Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France.Service de pharmacologie médicale et clinique, Centre de pharmacovigilance, de pharmacoépidémiologie et d’informations sur le médicament (CRPV), faculté de médecine, CHU de Toulouse37, allées Jules-GuesdeToulouse31000France

Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
Articolo gratuito.

Si connetta per beneficiarne

Summary

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.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Cohort study, COVID-19 vaccine, Pregnancy, Congenital anomalies, Pregnancy termination


Mappa


© 2024  Société française de pharmacologie et de thérapeutique. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
Aggiungere alla mia biblioteca Togliere dalla mia biblioteca Stampare
Esportazione

    Citazioni Export

  • File

  • Contenuto

Vol 80 - N° 3

P. 271-278 - maggio 2025 Ritorno al numero
Articolo precedente Articolo precedente
  • Évaluation des dépenses du circuit des produits de santé dans le cadre d’études institutionnelles – Étude de cas au CHU de Toulouse
  • Marie Delon, Pierjan Fourniols, Anabel Saint-Pastou, Geoffrey Bourcier, Audrey Tranier, Laetitia Caturla, Camille Jurado
| Articolo seguente Articolo seguente
  • Effets indésirables de l’association tezacaftor/ivacaftor/elexacaftor pouvant mener à un arrêt de traitement : à propos d’une série de 10 cas
  • Elora Blaisonneau, Brendan Le Daré, Marion Mercerolle, Astrid Bacle, Louise Triquet, Marie-Noëlle Osmont, Chantal Belleguic, Elisabeth Polard

Benvenuto su EM|consulte, il riferimento dei professionisti della salute.

@@150455@@ Voir plus

Il mio account


Dichiarazione CNIL

EM-CONSULTE.COM è registrato presso la CNIL, dichiarazione n. 1286925.

Ai sensi della legge n. 78-17 del 6 gennaio 1978 sull'informatica, sui file e sulle libertà, Lei puo' esercitare i diritti di opposizione (art.26 della legge), di accesso (art.34 a 38 Legge), e di rettifica (art.36 della legge) per i dati che La riguardano. Lei puo' cosi chiedere che siano rettificati, compeltati, chiariti, aggiornati o cancellati i suoi dati personali inesati, incompleti, equivoci, obsoleti o la cui raccolta o di uso o di conservazione sono vietati.
Le informazioni relative ai visitatori del nostro sito, compresa la loro identità, sono confidenziali.
Il responsabile del sito si impegna sull'onore a rispettare le condizioni legali di confidenzialità applicabili in Francia e a non divulgare tali informazioni a terzi.


Tutto il contenuto di questo sito: Copyright © 2026 Elsevier, i suoi licenziatari e contributori. Tutti i diritti sono riservati. Inclusi diritti per estrazione di testo e di dati, addestramento dell’intelligenza artificiale, e tecnologie simili. Per tutto il contenuto ‘open access’ sono applicati i termini della licenza Creative Commons.