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  • 1
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Objective To reduce the incidence of pre-eclampsia in nulliparous women, in accordance with the suggestion of a recent meta-analysis that low dose aspirin might decrease this incidence by more than half if used early enough in and at a sufficient dose during pregnancy (more than 75 mg).Design Multicentre randomised double-blinded placebo-controlled trial.Setting Twenty eight centres in Northern of France and one in Belgium.Population Three thousand and two hundred ninety-four nulliparous women recruited between 14 and 20 weeks.Methods Randomisation to either 100 mg aspirin or placebo daily from inclusion through 34 weeks.Main outcome measures Preeclampsia was defined as hypertension (≥140 and or 90 mmHg) associated with proteinuria (≥0.5 g/L).Results The aspirin (n= 1644) and placebo (n= 1650) groups did not differ significantly in the mothers' incidence of pre-eclampsia (28 of 1632 [1.7%] vs 26 of 1637 [1.6%]; relative risk, RR, 1.08, 95% CI 0.64–1.83), hypertension, HELLP syndrome or placental abruption, or in the children's incidence of perinatal deaths or birthweight below the 10th centile. The incidence of babies with birthweight below the third centile was significantly higher in the aspirin group, with no explanation. The incidence of maternal side effects was higher in the aspirin group, principally because of a significantly higher rate of haemorrhage.Conclusions Aspirin at a dose of 100 mg does not reduce the incidence of pre-eclampsia in nulliparous women. Aspirin (100 mg) is associated with an increase in bleeding complications.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: 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.Design Multicentre randomised controlled trial.Setting Eleven centres in the north of France and one in Belgium.Population 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.Main outcome measures Pre-eclampsia was defined as hypertension (≥ 140 and/or 90 mmHg) associated with proteinuria (≥ 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 (≤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).Conclusion Despite its sensitivity in screening for pre-eclampsia, routine uterine Doppler in the second trimester cannot be recommended for nulliparous patients.
    Type of Medium: Electronic Resource
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