Chapitre 4. Discussion et Conclusion
4.4 Implications pour les recherches futures
Nous suggérons que les critères de sélection d’un futur essai de grande envergure permettent de sélectionner des femmes à risques plus élevés de dysfonction placentaire ou de récidive de PE. Des données scientifiques récentes de notre équipe suggèrent que le risque de récidive de PE est presque nul (inférieur à 8 %) chez les femmes présentant un IP des artères utérines inférieur à 1,0 MoM, alors que le risque de récidive est élevé (supérieur à 15 %) chez celles ayant un IP > 1,0 MoM et très élevé (supérieur à 25 %) chez celles ayant un IP > 1,5 MoM.[88] De plus, comme les bénéfices de l’AAS sont possiblement spécifiques et plus importants chez les femmes à risque élevé de développer une PE préterme et/ou sévère, des formes de PE plus souvent associées à une dysfonction placentaire, il serait probablement important de recruter spécifiquement ces participantes dans un tel essai.[59, 60] L’utilisation de critères plus spécifiques à l’histoire des participantes (antécédent de PE sévère et/ou préterme); de marqueurs biochimiques (PAPP-A, sFlt-1, endogline); de Doppler des artères utérines; de facteurs de risque (hypertension chronique, diabète, etc.); ou de facteurs biophysiques (IMC élevé, tension artérielle élevée) pourrait possiblement permettre une sélection de femmes plus à risque.
Nous suggérons également l’utilisation d’une méthode différente, telle la compression, pour la fabrication du traitement afin d’éliminer toute possibilité pour la patiente, et le personnel de recherche, de connaître la dose attribuée au hasard ainsi que tout biais d’interprétation possible.
Conclusion
Dans l’ensemble, les résultats que nous avons obtenus confirment la faisabilité d’un essai randomisé comparant deux doses d’AAS chez les femmes avec un antécédent de PE. Un tel essai permettrait de connaître la dose optimale du traitement et l’utilité de la mesure de l’agrégation plaquettaire. La méthode de recrutement mise en place devrait considérer les barrières identifiées dans notre projet pilote. Nos données finales permettront d’établir la taille d’échantillon nécessaire et l’utilité du Doppler au 1er trimestre de la grossesse pour la réalisation d’un essai de grande envergure. Finalement, nous recommandons l’utilisation de comprimés plutôt que des capsules pour assurer un aveuglement complet chez les participantes.
39
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ANNEXE 1
ANNEXE 2
Sylvie Tapp
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ANNEXE 3
PROJET ASA GROSSESSE
VÉRIFICATION DE L’ÉLIGIBILITÉ Critères d’inclusion
OUI NON
1. Entre 8 0/7 et 13 6/7 semaines de grossesse
2. Antécédent de pré-éclampsie documenté (dossier)
3. La femme est apte à comprendre et signer le formulaire de consentement
Critères d’exclusion
1. Allergie anaphylactique au lactose
2. Prise d’héparine ou d’aspirine pour une raison autre que le projet de recherche actuel
3. Contre-indication à la prise d’aspirine
4. Coagulopathie connue (déficience anti-thrombine III, facteur V Leiden, syndrome anti- phospholipides, mutation de la prothrombine, déficience en protéine S ou en protéine C) 5. Hypertension artérielle pré-gestationnelle traitée
6. IMC>35 kg/m2
7. Maladies systémiques chroniques (incluant diabète, lupus, arthrite rhumatoïde, autres collagénoses)
8. Anomalie fœtale sévère (hygroma kystique, clarté nucale > 95ième percentile, anencéphalie, etc.) 9. Antécédents d’ulcères et/ou gastro-duodénales actives
10. Grossesse multiple
11. Accouchement prévu dans un autre centre que celui de l’étude (CHUL)
Si vous avez répondu ‘’OUI’’ à tous les critères d’inclusion et “NON” à tous les critères d’exclusion, la femme est ADMISSIBLE.
VÉRIFICATION DU CONSENTEMENT
Consentement obtenu NON OUI
Si NON, indiquer la(les) raison(s) du refus:
Si oui, FAIRE SIGNER LE CONSENTEMENT ET o Faire visite 1
OU
o Prendre rendez-vous à ≤7 jours – IMPORTANT– la visite DOIT être faite ≤ 13 6/7 semaines
DATE de signature du formulaire de consentement :______________________________________ DATE de la visite 1 (si ultérieure) : ______________________________________