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


CONCLUSIONS
In women with preeclampsia and platelet counts under 150×10/L, methylprednisolone was not effective in maintaining platelet counts above 100×10/L.


BACKGROUND
EU Clinical Trials Register, http://clinicaltrialsregister.eu, EudraCT 2006-004881-15-FR.
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.
Olivier
O
Pourrat
Marie
M
Dorey
Stéphanie
S
Ragot
Astrid
A
de Hauteclocque
Philippe
P
Deruelle
Michel
M
Dreyfus
Fabrice
F
Pierre
D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D017359:HELLP Syndrome / Q000097:blood / Q000517:prevention & control*; D006801:Humans; D008775:Methylprednisolone / Q000008:administration & dosage*; D010976:Platelet Count / Q000379:methods / Q000706:statistics & numerical data; D011225:Pre-Eclampsia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy; D011247:Pregnancy; D011256:Pregnancy Outcome
D005938:Glucocorticoids; D008775:Methylprednisolone