Caroline Diguisto1,2,3, Amelie Le Gouge4, Marie-Sara Marchand5, Pascal Megier6, Yves Ville7,8, Georges Haddad9, Norbert Winer10, Chloé Arthuis10, Muriel Doret11, Veronique Houfflin Debarge12, Anaig Flandrin13, Hélène Laurichesse Delmas14, Denis Gallot14, Pierre Mares15,16, Christophe Vayssiere17,18, Loïc Sentilhes19, Marie-Therese Cheve20, Anne Paumier21, Luc Durin22, Bruno Schaub23, Veronique Equy24, Bruno Giraudeau2,4, Franck Perrotin1,2. 1. Pôle de Gynécologie Obstétrique, Médecine Fœtale, Médecine et Biologie de la Reproduction, Centre Olympe de Gouges, CHRU de Tours, Tours, France. 2. Université de Tours, Tours, France. 3. Université de Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRAE,F, Paris, France. 4. INSERM CIC1415, CHRU de Tours, Tours, France. 5. Service de Pharmacovigilance CHU Tours, Tours, France. 6. Department of Gynaecology and Obstetrics, Centre Hospitalier Régional d'Orléans, Orleans, France. 7. Centre de Dépistage PRIMA FACIE Université de Paris, Paris, France. 8. Maternité, AP-HP, Hôpital Necker, Paris, France. 9. Cabinet Mosaïque Santé, La Chaussée Saint Victor, France. 10. Department of Obstetrics and Gynecology, University Hospital of Nantes, Nantes, NUN, INRAE, UMR 1280, PhAN, Université de Nantes, Nantes, France. 11. Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon, Lyon, France. 12. Department of Obstetrics, CHU Lille, Univ. Lille, ULR 2694-METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Lille, France. 13. Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier, Montpellier, France. 14. Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand, Maternité Clermont Ferrand, Clermont-Ferrand, France. 15. Département de Gynécologie Obstétrique, Centre Hospitalo-Universitaire Caremeau, Nîmes, France. 16. École de Maïeutique, Université de Montpellier, Site de Nîmes, Nîmes, France. 17. Department of Obstetrics and Gynaecology, Paule de Viguier Hospital, Toulouse University Hospital Center, Toulouse, France. 18. Centre for Epidemiology and Population Health Research, Team SPHERE, Toulouse III University, Toulouse, France. 19. Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux, Talence, France. 20. Service de Gynécologie-Obstétrique, CHR Le Mans, Le Mans, France. 21. Service de Gynécologie-Obstétrique, Polyclinique de l'Atlantique, Saint-Herblain, France. 22. Service de Gynécologie-Obstétrique, Polyclinique du Parc, Caen, France. 23. Service de Gynécologie-Obstétrique, Maison de la Femme, de la Mère et de l'Enfant, CHU Martinique, Fort-de-France, Martinique, France. 24. Service de Gynécologie-Obstétrique, Hôpital Couple Enfant, CHRU de Grenoble, La Tronche, France.
Abstract
INTRODUCTION: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. METHODS: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. RESULTS: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. CONCLUSION: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. TRIAL REGISTRATION: (NCT0172946).
INTRODUCTION: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. METHODS: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. RESULTS: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. CONCLUSION: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. TRIAL REGISTRATION: (NCT0172946).
Authors: L Velauthar; M N Plana; M Kalidindi; J Zamora; B Thilaganathan; S E Illanes; K S Khan; J Aquilina; S Thangaratinam Journal: Ultrasound Obstet Gynecol Date: 2014-04-04 Impact factor: 7.299
Authors: E Brunelli; A Seidenari; C Germano; F Prefumo; P Cavoretto; D Di Martino; B Masturzo; D Morano; N Rizzo; A Farina Journal: BJOG Date: 2020-04-10 Impact factor: 6.531
Authors: Ana Dubon Garcia; Roland Devlieger; Ken Redekop; Katleen Vandeweyer; Stefan Verlohren; Liona C Poon Journal: Pregnancy Hypertens Date: 2021-07-01 Impact factor: 2.899