Comparative trial of prednisone plus aspirin versus aspirin alone in the treatment of anticardiolipin antibody-positive obstetric patients

Am J Obstet Gynecol. 1993 Dec;169(6):1411-7. doi: 10.1016/0002-9378(93)90410-k.


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.

Study design: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Anticardiolipin / blood
  • Antiphospholipid Syndrome / blood
  • Antiphospholipid Syndrome / drug therapy*
  • Aspirin / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Obstetric Labor, Premature / chemically induced
  • Prednisone / adverse effects
  • Prednisone / therapeutic use*
  • Pregnancy
  • Pregnancy Complications / blood
  • Pregnancy Complications / drug therapy*
  • Pregnancy Outcome
  • Prospective Studies


  • Antibodies, Anticardiolipin
  • Aspirin
  • Prednisone