Randomised controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies)
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Objective To determine whether treatment with low dose aspirin and heparin leads to a higher rate of live births than that achieved with low dose aspirin alone in women with a history of recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies), lupus anticoagulant, and cardiolipin antibodies (or anticardiolipin antibodies). Design Randomised controlled trial. Setting Specialist clinic for recurrent miscarriages. Subjects 90 women (median age 33 (range 22-43)) with a history of recurrent miscarriage (median number 4 (range 3-15)) and persistently positive results for phospholipid antibodies. Intervention Either low dose aspirin (75 mg daily) or low dose aspirin and 5000 U of unfractionated heparin subcutaneously 12 hourly. All women started treatment with low dose aspirin when they had a positive urine pregnancy test. Women were randomly allocated an intervention when fetal heart activity was seen on ultrasonography. Treatment was stopped at the time of miscarriage or at 34 weeks' gestation. Main outcome measures Rate of live births with the two treatments. Results There was no significant difference in the two groups in age or the number and gestation of previous miscarriages. The rate of live births with low dose aspirin and heparin was 71% (32/45 pregnancies) and 42% (19/45 pregnancies) with low dose aspirin alone (odds ratio 3.37 (95% confidence interval 1.40 to 8.10)). More than 90% of miscarriages occurred in the first trimester. The…
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Pooled data from one RCT in women with first-trimester losses and eight observational studies not exclusively early losses indicated higher likelihood of live births with LDA plus prophylactic heparin versus LDA alone.
“Pooled data from one RCT including only patients with a history of first trimester losses46 and eight supporting observational studies47–54 that did not exclusively study women with early pregnancy losses indicated a higher likelihood of live births with combination treatment with LDA and heparin at prophylactic dosage versus LDA alone.”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [46]
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- Authors
- Rai, R., Cohen, H., Dave, M., & Regan, L.
- Affiliations
- Imperial College London (GB)
- Corresponding author
- Regan, L
- ORCID
- Cohen, H
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 1997-01-25
- Volume
- 314
- Issue
- 7076
- Pages
- 253
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC2125731
- OpenAlex
- W2061071054
- Cited by
- 1,113
- References
- 2
- Citations by year
- 2026: 10 · 2025: 9 · 2024: 14 · 2023: 12 · 2022: 15 · 2021: 18 · 2020: 46 · 2019: 23 · 2018: 22 · 2017: 30 · 2016: 52 · 2015: 28 · 2014: 42 · 2013: 38 · 2012: 45
- FWCI
- 28.48
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Medical Research Council
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Life Sciences › Immunology and Microbiology › Immunology › Reproductive System and Pregnancy
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- recurrent pregnancy loss, antiphospholipid antibodies, low-dose aspirin, unfractionated heparin, live birth rate, lupus anticoagulant, anticardiolipin antibodies, pregnancy outcomes, bone mineral density, first-trimester miscarriage, anticoagulation in pregnancy
- MeSH terms
- Abortion, Habitual, Adult, Aspirin, Female, Fibrinolytic Agents, Heparin, Humans, Immunoglobulin G, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Antiphospholipid Syndrome, Antibodies, Anticardiolipin
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