Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05625724 En recrutement IDF

Titre

Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART

Type

Interventional

Pathologie

Éclampsie
Pré-éclampsie

Phase

Phase 3

Promoteur

University Hospital, Toulouse (Voir sur ClinicalTrials)

Date de début

août 2023

Date de fin

mai 2029

Dernière mise à jour

08 mai 2026

Résumé

This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

Détail

Voir le détail Preeclampsia (PE) affects 2% of pregnancies in France and is an important cause of maternal and perinatal mortality and morbidity. Aspirin is currently the only prophylactic therapy for PE in high-risk women when initiated before 16 weeks of gestation and at a daily dose of 100-160 mg, with a reduction in the incidence of preterm preeclampsia of 60-70% in recent meta-analysis. Latest data also demonstrate a potential beneficial effect of aspirin on spontaneous preterm birth. A major challenge in modern obstetrics is early identification of pregnant women at high-risk of PE who could benefit from aspirin treatment. In France, the College National des Gynécologues et Obstétriciens Français and the Société Française d'HyperTension Artérielle have restrictive recommendation of aspirin to be prescribed only to women with a history of PE or vascular intra-uterine growth restriction, thus leaving out all nulliparous women (including those with multiple risk factors). Other countries (USA, United Kingdom (UK), Canada) have much broader recommendations with aspirin prescription for patients with one high or 2 moderate risk factors, but exposing nearly 30% of pregnant women to aspirin (leading to unnecessary exposure to treatment). The Fetal Medicine Foundation provides a screening test combining clinical parameters, uterine artery Doppler, and biomarkers; but this strategy has high false-positive rate and the reproducibility needs to be confirmed in clinical practice. It seems necessary to be able to better target women at risk, especially in nulliparous women. Nulliparity and assisted reproductive technology (ART) are independent risk factors for PE. Currently the proportion of pregnancy after ART in France is roughly 6.9% and is rising. Nulliparous ART pregnant women have a higher risk of PE and preterm birth. Indeed, they commonly cumulate risk factors including age>35years in association with nulliparity and ART. The rate of PE in this population can rise up to 10%. Our hypothesis is that nulliparous pregnant women after ART are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Armand Trousseau-La Roche Guyon	Gilles Kayem, MD	Recrutement non commencé	Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin	Vassilis Tsatsaris, MD	En recrutement IDF	Contact (sur clinicalTrials)
CHI POISSY ST-GERMAIN	Paul Berveiller, MD	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HM Hôpital de la Conception - Marseille - France	Blandine Courbière, MD	En recrutement	Contact (sur clinicalTrials)
CHU Dijon-Bourgogne - Dijon - France	Emmanuel Simon, MD	En recrutement	Contact (sur clinicalTrials)
CHU Montpellier - Montpellier - France	Noémie Ranisavljevic, MD	En recrutement	Contact (sur clinicalTrials)
CHU Nîmes - Nîmes - France	Stéphanie Huberlant, MD	En recrutement	Contact (sur clinicalTrials)
CHU Poitiers - Poitiers - France	Aurélie Brossard Violeau, MD	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Rennes - Rennes - France	Céline Pimentel, MD	En recrutement	Contact (sur clinicalTrials)
CHU Toulouse - Toulouse - France	Paul GUERBY, MD	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HM Hôpital Nord - Marseille - France	Julie Blanc, MD	En recrutement	Contact (sur clinicalTrials)
CHRU Nancy - Nancy - France	Catherine Zuili Lamy, MD	En recrutement	Contact (sur clinicalTrials)
CHU Angers - Angers - France	Pierre-Emmanuel BOUET, MD	En recrutement	Contact (sur clinicalTrials)
CHU Bordeaux - Bordeaux - France	Loic Sentilhes, MD	En recrutement	Contact (sur clinicalTrials)
CHU Clermont-Ferrand - Clermont-Ferrand - France	Amélie DELABAERE, MD	En recrutement	Contact (sur clinicalTrials)
CHU Lille - Lille - France	Véronique Debarge, MD	En recrutement	Contact (sur clinicalTrials)
CHU Nantes - Nantes - France	Vincent Dochez, MD	En recrutement	Contact (sur clinicalTrials)
CHU Saint Etienne, Hôpital Nord - Saint-Etienne - France	Tiphaine Barjat, MD		Contact (sur clinicalTrials)
CHU Strasbourg - Strasbourg - France	Catherine Rongières, MD	En recrutement	Contact (sur clinicalTrials)
Groupe hospitalier St Joseph - Paris - France	Elie Azria, MD	En recrutement	Contact (sur clinicalTrials)
HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant - Lyon - France	Mona Massoud, MD	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

- Nulliparous women aged 18 years or more

- Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic
sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm
donor

- Singleton pregnancy

- Evolutive pregnancy between 9 and 14 weeks of gestation

- Women affiliated to a French Social Security Insurance or equivalent social
protection

- Written informed consent

Exclusion Criteria:

Critère de non inclusion

- Major fetal abnormality

- Regular treatment with aspirin (including antiphospholipid syndrome)

- Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration,
hemophilia)

- Women protected by law.

- Women included in another interventional study.

NCT05625724 - Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut