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Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results


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Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results

 
  1. 1Department of Medicine, Hospital for Special Surgery, New York City, New York, USA
  2. 2Internal Medicine Department, University of Lille, UFR Médecine, Lille, France
  3. 3University of Toronto and LifeQuest Centre for Reproductive Medicine, Toronto, Canada
  4. 4Department of Obstetrics and Gynecology, University of Utah and Intermountain Healthcare, Salt Lake City, Utah, USA
  5. 5Department of Medicine, New York University School of Medicine, New York City, New York, USA
  6. 6Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  7. 7Department of Medicine, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA
  8. 8Department of Epidemiology and Public Health, Albert Einstein College of Medicine, New York City, New York, USA
  1. Correspondence to Professor Jane E Salmon; salmonj{at}hss.edu

Abstract

Objective We previously reported that lupus anticoagulant (LAC) is the main predictor of poor pregnancy outcome in antiphospholipid antibody (aPL)-positive patients. We sought to confirm this finding in an independent group of patients who were subsequently recruited into the PROMISSE study.

Methods The PROMISSE study is a multicentre, prospective, observational study of pregnancy outcomes in women with aPL and/or systemic lupus erythematosus (SLE) that enrolled patients from 2003 to 2015. All consecutive, aPL-positive patients from the PROMISSE study who completed their pregnancy between April 2011 and January 2015 (after the previous PROMISSE report) are included in the current report. Patients were followed monthly until delivery, and aPL was tested at first, second and third trimesters of pregnancy and at 12 weeks post partum. Adverse pregnancy outcomes (APOs) were defined as fetal death after 12 weeks of gestation, neonatal death, delivery prior to 36 weeks of gestation due to pre-eclampsia or placental insufficiency or small-for-gestational age (birth weight <5th percentile).

Results Forty-four aPL-positive patients are included in this paper. Thirteen patients had APOs, which occurred in 80% of cases during the second trimester of pregnancy. LAC was present in 69% of patients with APOs compared with 27% of patients without APOs (p=0.01). No association was found between anticardiolipin antibodies (aCL) or anti-β2 glycoprotein I antibodies (aβ2GPI) IgG or IgM positivity and APOs. Definite antiphospholipid syndrome (history of thrombosis and/or pregnancy morbidity and aPL) was found in 92% of patients with any APOs compared with 45% of patients without APOs (p=0.004). Conversely, the frequency of SLE was not statistically different between those with and without APOs (30% vs 39%).

Conclusions Our findings, in an independent group of aPL-positive patients from the PROMISSE study, confirm that LAC, but not aCL and aβ2GPI, is predictive of poor pregnancy outcomes after 12 weeks of pregnancy.

Trial registration number NCT00198068.

  • Received October 2, 2015.
  • Revision received November 17, 2015.
  • Accepted November 23, 2015.
  • Published 12 January 2016

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:http://creativecommons.org/licenses/by-nc/4.0/

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