Low-molecular-weight heparin and aspirin in the prevention of recurrent early-onset pre-eclampsia in women with antiphospholipid antibodies: the FRUIT-RCT
Abstract
Objective To examine whether combined treatment with low-molecular-weight heparin (LMWH) and aspirin reduces recurrent hypertensive disorders of pregnancy (HD: pre-eclampsia, eclampsia or HELLP syndrome) in women with antiphospholipid antibodies (aPLA) and a previous delivery for HD and/or small-for-gestational-age (SGA) birthweight before 34 weeks gestation.Study design This multicentre randomised controlled trial was performed between December 2000 and December 2009. Women were recruited from all eight university and six non-university/teaching hospitals in The Netherlands, two university hospitals in Australia and one university hospital in Sweden. Thirty two women with a previous delivery <34 weeks gestation with HD and/or SGA and aPLA were included before 12 weeks gestation. The intervention was daily LMWH with aspirin or aspirin alone.Primary outcomes recurrent HD onset <34 weeks and recurrent HD irrespective of gestational age. Analysis by intention-to-treat.Results After an interim analysis, recruitment was ceased: accrual was low and the incidence of recurrent HD was far lower (3%) than expected (60%). The final analysis, performed on 32 women, shows no difference in the primary outcomes (LMWH and aspirin 0/16 versus aspirin only 1/16, risk difference 6.25% [CI -17 to 27%] for recurrent HD onset <34 weeks and 0/16 for LMWH and aspirin versus 2/16 for aspirin only, risk difference 12.5% [CI -15 to 35%] for HD irrespective of gestational age).Conclusion In this population of women with aPLA, who had previously had an early delivery for HD and/or SGA prior to 34 weeks gestation, combined LMWH and aspirin treatment started before 12 weeks gestation in a subsequent pregnancy did not show reduction of onset of recurrent HD either <34 weeks gestation or irrespective of gestational age, compared with aspirin alone.
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Data from two studies showed no difference in likelihood of live births between LDA plus heparin and LDA alone in women with prior delivery before 34 weeks due to eclampsia, severe pre-eclampsia, or placental insufficiency.
“Data from two studies (one RCT, one retrospective cohort)48 55 showed that the likelihood of live births did not differ between women treated with LDA plus heparin and those treated with LDA alone.”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [55]
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Síndrome antifosfolípide obstétrica Número 6 – Junho 2021
de Barros, V. I. P. V. L., Igai, A. M. K., de Oliveira, A. L. M. L., Teruchkin, M. M., & Orsi, F. A. (2021) · Femina · doi:10.61622/0100-7254496202106
- Authors
- van Hoorn, M. E., Hague, W. M., van Pampus, M. G., Bezemer, D., & de Vries, J. I. P.
- Affiliations
- Women's and Children's Hospital (AU)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- ORCID
- Hague, William M.
- Venue
- European Journal of Obstetrics & Gynecology and Reproductive Biology
- Publisher
- Elsevier BV
- Published
- 2016-02
- Volume
- 197
- Pages
- 168-173
- ISSN
- 0028-2243 (ISSN-L)
- 0301-2115
- OpenAlex
- W2269554558
- Cited by
- 84
- References
- 21
- Citations by year
- 2026: 2 · 2025: 9 · 2024: 9 · 2023: 5 · 2022: 8 · 2021: 9 · 2020: 12 · 2019: 14 · 2018: 7 · 2017: 6 · 2016: 3
- FWCI
- 6.05
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Obstetrics & Gynecology and Reproductive Biology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Life Sciences › Immunology and Microbiology › Immunology › Reproductive System and Pregnancy
- Keywords
- low molecular weight heparin, aspirin, antiphospholipid antibodies, hypertensive disorders of pregnancy, HELLP syndrome, preterm birth, thromboprophylaxis
- MeSH terms
- Adult, Aspirin, Australia, Drug Therapy, Combination, Female, Fibrinolytic Agents, Gestational Age, Heparin, Low-Molecular-Weight, Humans, Infant, Newborn, Infant, Small for Gestational Age, Netherlands, Pre-Eclampsia, Pregnancy, Pregnancy Trimester, First, Recurrence, Sweden, Antiphospholipid Syndrome, Treatment Outcome, Antibodies, Antiphospholipid, Hypertension, Pregnancy-Induced, Premature Birth, Young Adult, Intention to Treat Analysis
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