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Abstract Full Text

Supplement to Belfort MA, Anthony J, Saade GR, Allen JC. A Comparison of Magnesium Sulfate and Nimodipine for the Prevention of Eclampsia. N Engl J Med 2003;348:304-11.

Supplementary Appendix

The final decision to enroll a patient in this study was made by the principal investigator at each site. The diagnosis of severe preeclampsia was based on the criteria of the American College of Obstetrics and Gynecology for the diagnosis of severe preeclampsia.¹⁶ The criteria for the diagnosis of preeclampsia were as follows: systolic blood pressure of 140 mm Hg or higher or diastolic blood pressure of 90 mm Hg or higher after 20 weeks of gestation in a woman with previously normal blood pressure, and proteinuria, defined as at least 0.3 g of protein in a 24-hour urine specimen. Since a 24-hour urine specimen was not a criterion in our trial, we used a semiquantitative dipstick measure of 1+ or greater to indicate proteinuria at a level of at least 0.3 g per day.

Preeclampsia was considered severe if one or more of the following criteria were present: systolic blood pressure of 160 mm Hg or higher or diastolic blood pressure of 110 mm Hg or higher (or a mean arterial pressure of 106 mm Hg) in association with proteinuria (as defined above), proteinuria of more than 5 g per 24 hours (or a dipstick finding of 3+ or 4+ in association with hypertension as defined above), or elevated blood pressure and proteinuria as defined above in association with any of the following: elevated serum creatinine level, pulmonary edema, oliguria (urinary output of less than 500 ml per 24 hours or of less than 30 ml per hour for 3 or more hours), microangiopathic hemolysis, thrombocytopenia (a platelet count of less than 150,000 per cubic millimeter; severe thrombocytopenia was defined as fewer than 50,000 platelets per cubic millimeter), hepatocellular dysfunction (as defined by an alanine aminotransferase level of more than 40 U per liter or an aspartate aminotransferase level of more than 40 U per liter), intrauterine growth restriction or oligohydramnios, or symptoms suggesting clinically significant end-organ involvement (headache, visual disturbances, or epigastric pain or right-upper-quadrant pain).

Abstract Full Text