OBJECTIVE: To determine whether n-3 fatty acid (EPA/DCHA) prophylaxis is beneficial in high risk pregnancies. DESIGN: A randomised, double blind, placebo controlled trial. SETTING: Antenatal clinic of St James's University Hospital, Leeds. SUBJECTS:Two hundred and thirty-three pregnant women at high risk of developing proteinuric or nonproteinuric pregnancy induced hypertension or asymmetrical intrauterine growth retardation. INTERVENTION: Active treatment was 2.7 g of MaxEpa daily (1.62 g of eicosapentaenoic acid and 1.08 g of docosahexaenoic acid). Placebo were matching air-filled capsules. MAIN OUTCOME MEASURES: Occurrence of proteinuric, nonproteinuric pregnancy induced hypertension or birthweight < 3rd centile. RESULTS: There was no difference in an intention to treat analysis between the placebo and active treatment groups for occurrence of proteinuric pregnancy induced hypertension (relative risk (RR) = 0.88; 95% CI 0.47-1.66), nonproteinuric pregnancy induced hypertension (RR = 0.89; 95% CI 0.48-1.64), birthweight < 3rd centile (RR = 0.89; 95% CI 0.48-1.64), or the duration of pregnancy (difference of mean durations = 0.1 days; 95% CI -4.8 to 4.9 days). Analyses stratified by use of tobacco, and analyses excluding known major protocol violators gave essentially identical results. CONCLUSION: There is no evidence from this study for any useful effect of fish oil supplementation for women at high risk of adverse outcomes from a pregnancy, but a small protective effect remains a possibility.
RCT Entities:
OBJECTIVE: To determine whether n-3 fatty acid (EPA/DCHA) prophylaxis is beneficial in high risk pregnancies. DESIGN: A randomised, double blind, placebo controlled trial. SETTING: Antenatal clinic of St James's University Hospital, Leeds. SUBJECTS: Two hundred and thirty-three pregnant women at high risk of developing proteinuric or nonproteinuric pregnancy induced hypertension or asymmetrical intrauterine growth retardation. INTERVENTION: Active treatment was 2.7 g of MaxEpa daily (1.62 g of eicosapentaenoic acid and 1.08 g of docosahexaenoic acid). Placebo were matching air-filled capsules. MAIN OUTCOME MEASURES: Occurrence of proteinuric, nonproteinuric pregnancy induced hypertension or birthweight < 3rd centile. RESULTS: There was no difference in an intention to treat analysis between the placebo and active treatment groups for occurrence of proteinuric pregnancy induced hypertension (relative risk (RR) = 0.88; 95% CI 0.47-1.66), nonproteinuric pregnancy induced hypertension (RR = 0.89; 95% CI 0.48-1.64), birthweight < 3rd centile (RR = 0.89; 95% CI 0.48-1.64), or the duration of pregnancy (difference of mean durations = 0.1 days; 95% CI -4.8 to 4.9 days). Analyses stratified by use of tobacco, and analyses excluding known major protocol violators gave essentially identical results. CONCLUSION: There is no evidence from this study for any useful effect of fish oil supplementation for women at high risk of adverse outcomes from a pregnancy, but a small protective effect remains a possibility.
Authors: Emily Oken; Yi Ning; Sheryl L Rifas-Shiman; Janet W Rich-Edwards; Sjurdur F Olsen; Matthew W Gillman Journal: Ann Epidemiol Date: 2007-05-23 Impact factor: 3.797