Discussion
In our study, supplementation with vitamins C and E did not reduce the frequency of the primary outcome or any of its components. We chose the primary outcome of new-onset pregnancy-associated
hypertension with evidence of maternal, fetal, or neonatal complications, rather than the diagnosis of preeclampsia, so that we could assess whether therapy would prevent serious complications rather than merely modify diagnostic findings. We did not require the presence of proteinuria as part of the primary outcome, since severe hypertension without proteinuria can be associated with adverse maternal and fetal outcomes.
Furthermore, a diagnosis of proteinuria that isbased on the qualitative assessment of random urine samples or even on protein-to-creatinine ratios cannot be compared with a diagnosis that is based on 24-hour urine collections.21-24 Since our primary outcome was not based on a conventional diagnosis of preeclampsia, we used preeclampsia as a major secondary outcome. The rates of mild preeclampsia, severe preeclampsia, the HELLP syndrome, and eclampsia were not significantly affected by vitamin treatment. There was also no evidence of a benefit with vitamin therapy with respect to any of the other prespecified secondaryoutcomes.
Several other trials have examined the effectiveness of vitamins C and E in preventing preeclampsia. 11-14 The doses of vitamins that were used in those trials were the same as those used in
our trial. Each of the previous trials had a smaller sample than that in our study; only one of the previous trials included low-risk subjects.13 In no other study was therapy initiated as early as it was in our trial. The Vitamins in Pre-eclampsia
DiscussionIn our study, supplementation with vitamins C and E did not reduce the frequency of the primary outcome or any of its components. We chose the primary outcome of new-onset pregnancy-associatedhypertension with evidence of maternal, fetal, or neonatal complications, rather than the diagnosis of preeclampsia, so that we could assess whether therapy would prevent serious complications rather than merely modify diagnostic findings. We did not require the presence of proteinuria as part of the primary outcome, since severe hypertension without proteinuria can be associated with adverse maternal and fetal outcomes. Furthermore, a diagnosis of proteinuria that isbased on the qualitative assessment of random urine samples or even on protein-to-creatinine ratios cannot be compared with a diagnosis that is based on 24-hour urine collections.21-24 Since our primary outcome was not based on a conventional diagnosis of preeclampsia, we used preeclampsia as a major secondary outcome. The rates of mild preeclampsia, severe preeclampsia, the HELLP syndrome, and eclampsia were not significantly affected by vitamin treatment. There was also no evidence of a benefit with vitamin therapy with respect to any of the other prespecified secondaryoutcomes. Several other trials have examined the effectiveness of vitamins C and E in preventing preeclampsia. 11-14 The doses of vitamins that were used in those trials were the same as those used inour trial. Each of the previous trials had a smaller sample than that in our study; only one of the previous trials included low-risk subjects.13 In no other study was therapy initiated as early as it was in our trial. The Vitamins in Pre-eclampsia
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