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Repeated fetal losses associated with antiphospholipid antibodies: A collaborative randomized trial comparing prednisone with low-dose heparin treatment

  • Author Footnotes
    a From the Departments of Medicine and Obstetrics and Gynecology
    ,
    Author Footnotes
    f A complete list of participating institutions and contributors appears at the end of the article.
    F. Susan Cowchock
    Correspondence
    Reprint requests: F. Susan Cowchock, MD, Department of Obstetrics and Gynecology, Jefferson Medical College, Philadelphia, PA 19107.
    Footnotes
    a From the Departments of Medicine and Obstetrics and Gynecology
    f A complete list of participating institutions and contributors appears at the end of the article.
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  • Author Footnotes
    c Jefferson Medical College, the Department of Obstetrics and Gynecology, Yale University School of Medicine
    ,
    Author Footnotes
    f A complete list of participating institutions and contributors appears at the end of the article.
    E. Albeit Reece
    Footnotes
    c Jefferson Medical College, the Department of Obstetrics and Gynecology, Yale University School of Medicine
    f A complete list of participating institutions and contributors appears at the end of the article.
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  • Author Footnotes
    b Greenfield Research Center, Department of Family Medicine
    ,
    Author Footnotes
    f A complete list of participating institutions and contributors appears at the end of the article.
    Donald Balaban
    Footnotes
    b Greenfield Research Center, Department of Family Medicine
    f A complete list of participating institutions and contributors appears at the end of the article.
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  • Author Footnotes
    d Department of Obstetrics and Gynecology, University of Utah School of Medicine
    ,
    Author Footnotes
    f A complete list of participating institutions and contributors appears at the end of the article.
    D. Ware Branch
    Footnotes
    d Department of Obstetrics and Gynecology, University of Utah School of Medicine
    f A complete list of participating institutions and contributors appears at the end of the article.
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  • Author Footnotes
    e Department of Obstetrics and Gynecology, Medical College of Georgia.
    ,
    Author Footnotes
    f A complete list of participating institutions and contributors appears at the end of the article.
    L. Plouffe
    Footnotes
    e Department of Obstetrics and Gynecology, Medical College of Georgia.
    f A complete list of participating institutions and contributors appears at the end of the article.
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  • Author Footnotes
    a From the Departments of Medicine and Obstetrics and Gynecology
    b Greenfield Research Center, Department of Family Medicine
    c Jefferson Medical College, the Department of Obstetrics and Gynecology, Yale University School of Medicine
    d Department of Obstetrics and Gynecology, University of Utah School of Medicine
    e Department of Obstetrics and Gynecology, Medical College of Georgia.
    f A complete list of participating institutions and contributors appears at the end of the article.
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      OBJECTIVE: We attempted to compare the use of low-dose heparin with a standard dose of 40 mg prednisone daily (both plus low-dose aspirin) for treatment of pregnant women with antiphospholipid antibody—associated recurrent fetal loss with respect to maternal and perinatal morbidity and efficacy in prevention of fetal death.
      STUDY DESIGN: A multicenter randomized trial included 20 patients. Generalizability of results from randomized patients was evaluated by means of additional data from 13 women refusing and 12 women ineligible for randomization. Data from study groups were compared with Fisher's exact test, and generalizability was evaluated with a χ2 test for trend.
      RESULTS: Live birth rates were the same (75%) with either treatment, but “serious” maternal morbidity and the frequency of preterm delivery were significantly higher among women randomly assigned to prednisone (p = 0.02 vs p = 0.006). Preterm delivery among prednisone-treated women was usually associated with premature rupture of the membranes or preeclampsia. These results could be generalized to the other groups of women ascertained during the course of the study.
      CONCLUSIONS: Low-dose heparin should be preferred to prednisone when treatment is indicated for high-risk pregnant women with antiphospholipid antibodies.

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