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Type: Journal article
Title: Aspirin plus Heparin or Aspirin alone in women with recurrent miscarriage
Author: Kaandorp, S.
Goddijn, M.
van der Post, J.
Hutten, B.
Verhoeve, H.
Hamulyak, K.
Mol, B.
Folkeringa, N.
Nahuis, M.
Papatsonis, D.
Buller, H.
van der Veen, F.
Middeldorp, S.
Citation: New England Journal of Medicine, 2010; 362(17):1586-1596
Publisher: Massachusetts Medical Society
Issue Date: 2010
ISSN: 0028-4793
Statement of
Stef P. Kaandorp, Mariëtte Goddijn, Joris A.M. van der Post, Barbara A. Hutten, Harold R. Verhoeve, Karly Hamulyák, Ben Willem Mol, Nienke Folkeringa, Marleen Nahuis, Dimitri N.M. Papatsonis, Harry R. Büller, Fulco van der Veen and Saskia Middeldorp
Abstract: BACKGROUND: Aspirin and low-molecular-weight heparin are prescribed for women with unexplained recurrent miscarriage, with the goal of improving the rate of live births, but limited data from randomized, controlled trials are available to support the use of these drugs. METHODS: In this randomized trial, we enrolled 364 women between the ages of 18 and 42 years who had a history of unexplained recurrent miscarriage and were attempting to conceive or were less than 6 weeks pregnant. We then randomly assigned them to receive daily 80 mg of aspirin plus open-label subcut aneous nadroparin (at a dose of 2850 IU, starting as soon as a viable pregnancy was demonstrated), 80 mg of aspirin alone, or placebo. The primary outcome measure was the live-birth rate. Secondary outcomes included rates of miscarriage, obstetrical complications, and maternal and fetal adverse events. RESULTS: Live-birth rates did not differ significantly among the three study groups. The proportions of women who gave birth to a live infant were 54.5% in t he group receiving aspirin plus nadroparin (combination-therapy group), 50.8% in the aspirin-only group, and 57.0% in the placebo group (absolute difference in live-birth rate: combination therapy vs. placebo, −2.6 percentage points; 95% confidence interval [CI], −15.0 to 9.9; aspirin only vs. placebo, −6.2 percentage points; 95% CI, −18.8 to 6.4). Among 299 women who became pregnant, the live-birth rates were 69.1% in the combination-therapy group, 61.6% in the aspirin-only group, and 67.0% in the placebo group (absolute difference in live-birth rate: combination therapy vs. placebo, 2.1 percentage points; 95% CI, −10.8 to 15.0; aspirin alone vs. placebo −5.4 percentage points; 95% CI, −18.6 to 7.8). An increased tendency to bruise and swelling or itching at the injection site occurred significantly more frequently in the combination-therapy group than in the other two study groups. CONCLUSIONS: Neither aspirin combined with nadroparin nor aspirin alone improved the live-birth rate, as compared with placebo, among women with unexplained recurrent miscarriage. (Current Controlled Trials number, ISRCTN58496168.)
Keywords: Humans; Abortion, Habitual; Contusions; Aspirin; Nadroparin; Anticoagulants; Platelet Aggregation Inhibitors; Treatment Failure; Drug Therapy, Combination; Pregnancy; Adult; Female; Live Birth; Young Adult
Rights: Copyright © 2010 Massachusetts Medical Society. All rights reserved.
RMID: 0020136692
DOI: 10.1056/NEJMoa1000641
Appears in Collections:Obstetrics and Gynaecology publications

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