Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

Summary

The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.

Timeline

Start

2012-06-27

Primary completion

2016-10-25

Completion

2016-10-25

Outcome

Missed primary endpoint

paper proportion difference 1.6 [-2.6; 5.9] p = 0.45 PMID 36260615 ↗

paper Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile PMID 36260615 ↗

Publications

• Background Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
• Background Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
• Background Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
• Results Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial. PLoS One. 2022 Oct 19;17(10):e0275129. doi: 10.1371/journal.pone.0275129. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	160 mg	—

Indications