OBJECTIVE: To assess the effect of low dose aspirin on severe pre-eclampsia when given to women identified as high risk by abnormal uterine artery Doppler ultrasound. DESIGN:Women with abnormal uterine artery flow velocity waveforms were recruited to the CLASP trial at 24 weeks. Abnormal uterine artery waveforms, with a high resistance index or an early diastolic notch, were identified at the 18-22 week anomaly scan and confirmed at 24 weeks. Of those women with persistently abnormal waveforms, 63 agreed to enter the CLASP trial. Three women were lost to follow up and five did not comply. Thus, 60 were randomised: 29 to placebo and 31 to low dose aspirin (60 mg daily) and analysis by intention to treat is reported. RESULTS: There were nine cases (29%) of pre-eclampsia in the aspirin group and twelve (41%) in the placebo group (odds ratio (OR) 0-58, confidence interval (CI) 0.2-1.69, P = 0.32). Severe pre-eclampsia developed in four women in the aspirin group and eleven women in the placebo group (OR 0.24, CI 0.07-0.88, P = 0.03) and intrauterine growth retardation occurred in eight cases in the aspirin group and twelve in the placebo group (OR 0.49, CI 0.17-1.47). The mean birthweight and gestation at delivery were 2.69 kg and 38.5 weeks in the aspirin group and 2.38 kg and 37.4 weeks in the placebo group, neither of which were statistically significant using the unpaired t test; P = 0.09 and P = 0.23, respectively. CONCLUSION: In high risk pregnancy low dose aspirin commenced at 24 weeks may reduce the incidence of severe pre-eclampsia.
RCT Entities:
OBJECTIVE: To assess the effect of low dose aspirin on severe pre-eclampsia when given to women identified as high risk by abnormal uterine artery Doppler ultrasound. DESIGN:Women with abnormal uterine artery flow velocity waveforms were recruited to the CLASP trial at 24 weeks. Abnormal uterine artery waveforms, with a high resistance index or an early diastolic notch, were identified at the 18-22 week anomaly scan and confirmed at 24 weeks. Of those women with persistently abnormal waveforms, 63 agreed to enter the CLASP trial. Three women were lost to follow up and five did not comply. Thus, 60 were randomised: 29 to placebo and 31 to low dose aspirin (60 mg daily) and analysis by intention to treat is reported. RESULTS: There were nine cases (29%) of pre-eclampsia in the aspirin group and twelve (41%) in the placebo group (odds ratio (OR) 0-58, confidence interval (CI) 0.2-1.69, P = 0.32). Severe pre-eclampsia developed in four women in the aspirin group and eleven women in the placebo group (OR 0.24, CI 0.07-0.88, P = 0.03) and intrauterine growth retardation occurred in eight cases in the aspirin group and twelve in the placebo group (OR 0.49, CI 0.17-1.47). The mean birthweight and gestation at delivery were 2.69 kg and 38.5 weeks in the aspirin group and 2.38 kg and 37.4 weeks in the placebo group, neither of which were statistically significant using the unpaired t test; P = 0.09 and P = 0.23, respectively. CONCLUSION: In high risk pregnancy low dose aspirin commenced at 24 weeks may reduce the incidence of severe pre-eclampsia.
Authors: Enrique F Schisterman; Robert M Silver; Neil J Perkins; Sunni L Mumford; Brian W Whitcomb; Joseph B Stanford; Laurie L Lesher; David Faraggi; Jean Wactawski-Wende; Richard W Browne; Janet M Townsend; Mark White; Anne M Lynch; Noya Galai Journal: Paediatr Perinat Epidemiol Date: 2013-10-11 Impact factor: 3.980