Do low-risk pregnant women with antiphospholipid antibodies need to be treated?,☆☆,,★★

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Abstract

We identified 19 women who had persistently positive test results for antiphospholipid antibodies who were considered to be at low risk because they had none of the associated signs or symptoms of the antiphospholipid antibody syndrome. They had had no (10/19, 53%) or just one prior spontaneous abortion and did not have a history of thrombosis or thrombocytopenia. Many (8/19, 42%) had had a prior uncomplicated pregnancy ending in a live birth. These women were randomly assigned to receive low-dose aspirin (81 mg daily) or usual care. There were few obstetric complications recorded in either treatment group. One woman in the aspirin group had a fetal death, and one in the usual care group had a low-birth-weight infant. The frequency of complications was so low that >600 such women would need to be entered into a randomized trial to evaluate whether low-dose aspirin would be beneficial treatment during a pregnancy. We concluded that treatment of pregnant women with antiphospholipid antibodies who are otherwise at low risk cannot be justified on the basis of the available evidence. (Am J Obstet Gynecol 1997;176:1099-100.)

Section snippets

Methods

Pregnant women at low risk were defined as those who had zero to two spontaneous abortions, only one of which could have occurred after 12 weeks of pregnancy (fetal death). They also must have had no history of antiphospholipid antibody–related complications such as thrombosis, thrombocytopenia, or early-onset preeclampsia. Tests for immunoglobulin G or M anticardiolipin antibodies or lupus anticoagulants gave persistently positive results, as defined in the published trial.1 The patients were

Results

The patients' obstetric histories, pregnancy outcomes, and antiphospholipid antibody test results are summarized in Table I. None of the differences between groups was statistically significant (p < 0.05) according to Fisher's exact test.

Comment

The results suggested to us that women whose positive antiphospholipid antibody status is diagnosed almost incidentally (in these cases often because of a false-positive serologic test for syphilis) are not at high risk for antiphospholipid antibody–related obstetric complications. The prevalence of any complication in the control group was 13% (95% confidence interval 0.3% to 53%). Given this low frequency of complications, 384 pairs of similar women would need to be entered into a randomized

Acknowledgements

Members of the Organizing Group of the Antiphospholipid Antibody Treatment Trial are as follows: D. Ware Branch, MD, University of Utah, Salt Lake City, Utah; Donald Balaban, MD, and Susan Cowchock, MD, Jefferson Medical College, Philadelphia, Pennsylvania; and Leo Plouffe, MD, Medical College of Georgia, Augusta, Georgia.

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    Citation Excerpt :

    No trials have directly compared aspirin with heparin or LMWH. As a single agent for the treatment of aPL-associated pregnancy complications, there are at least three randomized trials that have compared aspirin versus placebo or usual care in women with no previous thrombosis [60–62]. None found a benefit of aspirin, although the third study included women with recurrent spontaneous abortions with or without detectable aCL [61].

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From the Jefferson Medical College of Thomas Jefferson University and the School of Medicine, Temple University. Members of the Organizing Group of the Antiphospholipid Antibody Treatment Trial are listed at the end of the article.

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Supported by National Institute of Child Health and Human Development grant 080-02154.

Reprints not available from the authors.

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