Comparative trial of prednisone plus aspirin versus aspirin alone in the treatment of anticardiolipin antibody-positive obstetric patients.
OBJECTIVE
We compared the use of aspirin alone with combined therapy (prednisone plus aspirin) in antiphospholipid antibody-positive obstetric patients with prior adverse pregnancy outcome.


METHODS
Thirty-nine patients meeting specific laboratory and clinical inclusion criteria were randomized to receive either combined therapy (prednisone plus low-dose aspirin, n = 17) or aspirin alone (n = 22). The daily aspirin dose was 81 mg; prednisone was begun at 20 mg/day and increased or decreased on the basis of observed changes in serial antibody levels. Perinatal outcomes were compared between groups. Evaluation of treatment-related maternal complications and serial antibody titers was also accomplished.


RESULTS
Thirty-four randomized subjects were evaluable (prednisone plus low-dose aspirin, n = 12 vs aspirin only, n = 22); no perinatal losses were observed in the study cohort. Preterm delivery was experienced by significantly more patients receiving prednisone plus low-dose aspirin than aspirin only (8/12 vs 3/22, respectively; p = 0.003), and prednisone exposure appeared to be an independent risk factor for preterm birth.


CONCLUSIONS
The use of prednisone therapy in conjunction with low-dose aspirin does not appear to improve outcome and may provoke obstetric complications in antiphospholipid antibody-positive patients.
Silver
R K
RK
Division of Maternal-Fetal Medicine, Evanston Hospital, IL 60201.
MacGregor
S N
SN
Sholl
J S
JS
Hobart
J M
JM
Neerhof
M G
MG
Ragin
A
A
D000328:Adult; D017153:Antibodies, Anticardiolipin / Q000097:blood; D016736:Antiphospholipid Syndrome / Q000097:blood / Q000188:drug therapy*; D001241:Aspirin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007752:Obstetric Labor, Premature / Q000139:chemically induced; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011446:Prospective Studies
D017153:Antibodies, Anticardiolipin; D001241:Aspirin; D011241:Prednisone