High-Dose Methylprednisolone to Prevent Platelet Decline in Preeclampsia: A Randomized Controlled Trial

• Published in: Obstetrics and gynecology (New York. 1953) Vol. 128; no. 1; pp. 153 - 158
• Main Authors: Pourrat, Olivier, Dorey, Marie, Ragot, Stéphanie, de Hauteclocque, Astrid, Deruelle, Philippe, Dreyfus, Michel, Pierre, Fabrice
• Format: Journal Article
• Language: English
• Published: United States by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved 01.07.2016
• Subjects: Adult; Blood Coagulation - drug effects; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Monitoring - methods; Female; Glucocorticoids - administration & dosage; HELLP Syndrome - blood; HELLP Syndrome - prevention & control; Humans; Methylprednisolone - administration & dosage; Platelet Count - methods; Platelet Count - statistics & numerical data; Pre-Eclampsia - blood; Pre-Eclampsia - diagnosis; Pre-Eclampsia - drug therapy; Pregnancy; Pregnancy Outcome
• ISSN: 0029-7844; 1873-233X
• DOI: 10.1097/AOG.0000000000001470

OBJECTIVE:To evaluate whether early administration of high-dose methylprednisolone limits the fall of platelets in preeclampsia. METHODS:A randomized trial of 180 mg methylprednisolone or placebo administered in divided doses over 36 hours was conducted in women admitted for preeclampsia and platelet counts below 150×10/L in four French academic centers. Patients were not included when platelet counts were below 50×10/L or when immediate delivery was required. The primary study outcome was the proportion of patients with platelet counts above 100×10/L 36 hours after the first dose of study medication. The total sample size needed to detect a 23% difference in the rate of this outcome between groups with a one-tailed α of 0.05 and 90% power was 94 patients. RESULTS:Thirty-six patients were randomly assigned to receive methylprednisolone and 34 placebo between October 2007 and May 2011. Platelet counts above 100×10/L at 36 hours after the first dose of study medication were recorded in 30 (83%) in the active group and 29 (85%) in the placebo group (relative risk 0.98, 95% confidence interval 0.80–1.20; P=.82). The only adverse potentially study-related event was hyperglycemia in one woman allocated to methylprednisolone. CONCLUSION:In women with preeclampsia and platelet counts under 150×10/L, methylprednisolone was not effective in maintaining platelet counts above 100×10/L. CLINICAL TRIAL REGISTRATION:EU Clinical Trials Register, http://clinicaltrialsregister.eu, EudraCT 2006-004881-15-FR.