Olivier Pourrat1, Marie Dorey, Stéphanie Ragot, Astrid de Hauteclocque, Philippe Deruelle, Michel Dreyfus, Fabrice Pierre. 1. From CHU de Poitiers, ICU and Internal Medicine, Service de Gynécologie, Obstétrique et Médecine de la Reproduction, Centre d'Investigation Clinique, Poitiers, France; INSERM, CIC1402, Poitiers, France; Université de Poitiers, UFR Médecine Pharmacie, Poitiers, France; Université de Lille 2 Pôle Recherche, Lille, France; and Université de Caen, Caen, France.
Abstract
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.
RCT Entities:
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.