Screening with a uterine Doppler in low risk pregnant women followed by low dose aspirin in women with abnormal results: a multicenter randomised controlled trial

Abstract

Collaborators and participating centres of the French Doppler study group are listed on page 517.Objectives To assess whether systematic screening with an uterine artery Doppler in low risk pregnant women followed by the prescription of low dose aspirin in cases with abnormal results reduced the incidence of intrauterine growth restriction and pre-eclampsia.Design A multicentre randomised trial.Population 3317 low risk pregnant women. In the Doppler group, the uterine artery Doppler was performed between 20 and 24 weeks. Women with abnormal results received 100 mg of aspirin daily until the 35th week. Main outcome measures Intrauterine growth restriction was de®ned as birthweight below the tenth and the third centile according to gestational age. Pre-eclampsia was de®ned as hypertension associated with proteinuria . 0.5g/L.Results Intrauterine growth restriction, whether de®ned by the third or tenth centile, did not differ signi®cantly between the two groups (RR 1.22 [0.73 -2.04] and 1.18 [0.93 -1.51] respectively). Screening with uterine artery Doppler did not affect birthweight or any of the criteria of perinatal morbidity. There was no effect on the incidence of pre-eclampsia (RR 1.99 [0.97 -4.09]) or hypertensive disorders. These results were the same for nulliparae and multiparae. Conclusions There is no justi®cation for screening with uterine artery Doppler in a low risk population, even if abnormal results are followed by aspirin treatment and increased prenatal surveillance. Future studies must assess predictive tests that can be performed early in pregnancy and can identify populations at very high risk of pre-eclampsia and intrauterine growth restriction. Only when all of these conditions are ful®lled, aspirin or other treatments may prove its ef®cacy.

World Health Organization Systematic Review of Screening Tests for Preeclampsia

“…112,113 These findings could be explained by either the low predictive accuracy of Doppler ultrasonography or by the modest efficacy of aspirin to prevent preeclampsia.…”

Serum markers for predicting pre-eclampsia

“…Large multi-centre studies evaluated whether aspirin treatment, started at 22-24 weeks of gestation, would be beneficial in women with abnormal midtrimester uterine artery Doppler results (Yu et al, 2003;Goffinet et al, 2001;Subtil et al, 2003). With respect to pre-eclampsia, no alteration in pregnancy outcome was observed following aspirin intake.…”

“…Assessed during midtrimester, such abnormal Doppler findings indicate a substantially increased risk for developing pre-eclampsia (Conde-Agudelo et Chien et al, 2000). In randomized controlled trials using aspirin treatment for preventing pre-eclampsia in women with abnormal midtrimester uterine artery Doppler results, Doppler screening for predicting pre-eclampsia yielded sensitvities up to 60% and positive predictive values up to 40% (Yu et al, 2003;Goffinet et al, 2001;Subtil et al, 2003). However, in women with abnormal midtrimester Doppler measurements, Aspirin treatment did not alter the pregnancy outcome compared to controls.…”

Variation in outcome reporting in randomized controlled trials of interventions for prevention and treatment of fetal growth restriction

“…Seventy‐two reports from 68 trials met the inclusion criteria and were included in the systematic review (Figure ). Forty‐four trials reported on potential interventions for the prevention of FGR and 24 (29 studies) reported on interventions for the treatment of pregnancies affected by FGR. Five papers reporting outcomes from the DIGITAT trial and two from the TRUFFLE trial were included.…”