Randomised comparison of uterine artery Doppler and aspirin (100 mg) with placebo in nulliparous women: the Essai Régional Aspirine Mère-Enfant study (Part 2).
OBJECTIVE
To assess the effectiveness of a pre-eclampsia prevention strategy based on routine uterine artery Doppler flow velocity waveform examination during the second trimester of pregnancy, followed by a prescription for 100 mg aspirin in the case of abnormal Doppler findings.


METHODS
Multicentre randomised controlled trial.


METHODS
Eleven centres in the north of France and one in Belgium.


METHODS
One thousand and eight hundred and fifty-three nulliparous women recruited between 14 and 20 weeks of gestation.


METHODS
Randomisation either to undergo a uterine Doppler examination between 22 and 24 week of gestation or to take a placebo. Women with abnormal Doppler waveforms received 100 mg of aspirin daily from Doppler examination through 36 weeks.


METHODS
Pre-eclampsia was defined as hypertension (> or = 140 and/or 90 mmHg) associated with proteinuria (> or = 0.5 g/L).


RESULTS
One thousand two hundred and fifty-three women (67%) were randomised into the systematic Doppler group and 617 (33%) into the placebo group. Of the 1175 patients in the Doppler group who underwent this examination, 239 (20.3%) had abnormal uterine artery Doppler and received a prescription for aspirin. Despite the aspirin prescription, the frequency of pre-eclampsia did not differ between the systematic Doppler group and the placebo group (28 of 1237 [2.3%] vs 9 of 616 [1.5%]; RR = 1.55, 95% CI 0.7-3.3). Furthermore, the groups did not differ in the frequency of children who were very small for their gestational age (< or =3rd centile) or for perinatal deaths. Compared with patients with normal Doppler findings, those with abnormal Doppler were at high risk of pre-eclampsia (RR = 5.5, 95% CI 2.5-12.2) and of giving birth to a small-for-gestational-age child (RR = 3.6, 95% CI 1.6-8.1).


CONCLUSIONS
Despite its sensitivity in screening for pre-eclampsia, routine uterine Doppler in the second trimester cannot be recommended for nulliparous patients.
Damien
D
Subtil
Patrice
P
Goeusse
Véronique
V
Houfflin-Debarge
Francis
F
Puech
Pierre
P
Lequien
Gérard
G
Breart
Serge
S
Uzan
Florence
F
Quandalle
Yves Marie
YM
Delcourt
Yves Marie
YM
Malek
D000328:Adult; D001158:Arteries / Q000502:physiology; D001241:Aspirin / Q000627:therapeutic use*; D005260:Female; D005317:Fetal Growth Retardation / Q000209:etiology; D006801:Humans; D021041:Placental Circulation / Q000502:physiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011225:Pre-Eclampsia / Q000000981:diagnostic imaging / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D012680:Sensitivity and Specificity; D018608:Ultrasonography, Doppler / Q000379:methods; D016216:Ultrasonography, Prenatal / Q000379:methods; D014599:Uterus / Q000098:blood supply*
D010975:Platelet Aggregation Inhibitors; D001241:Aspirin