Table 1.
Baseline characteristics of the study population
| Characteristics* | Total population n=152 |
APOs n=46 |
No APOs n=106 |
p-value † |
|---|---|---|---|---|
| Age (years) § | 31.9 (4.6) | 30.6 (5.02) | 32.5 (4.38) | 0.02 |
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| ||||
| Ethnicity | ||||
| Hispanic | 13 (9%) | 6 (13%) | 7 (7%) | 0.22 |
| Non-Hispanic | 139 (91%) | 40 (87%) | 99 (93%) | |
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| Race | ||||
| White | 128 (90%) | 37 (88%) | 91 (90%) | 0.76 |
| Non-White | 15 (10%) | 5 (12%) | 10 (10%) | |
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| ||||
| BMI | ||||
| < 25 | 78 (55%) | 15 (35%) | 63 (64%) | 0.01 |
| 25–30 | 34 (24%) | 13 (30%) | 21 (21%) | 0.01 |
| > 30 | 30 (21%) | 15 (35%) | 15 (15%) | 0.001 |
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| SLE | 54 (36%) | 19 (41%) | 35 (33%) | 0.33 |
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| ||||
| APS | 87 (57%) | 35 (76%) | 52 (49%) | 0.002 |
| History of thrombosis | 37 (24%) | 22 (48%) | 15 (14%) | 0.0001 |
| History of obstetrical manifestations | 72 (47%) | 25 (54%) | 48 (45%) | 0.23 |
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| Treatment during pregnancy | ||||
| Hydroxychloroquine | 43 (28%) | 13 (28%) | 30 (28%) | 0.99 |
| Corticosteroids | 16 (11%) | 3 (7%) | 13 (12%) | 0.39 |
| Aspirin | 110 (72%) | 26 (57%) | 84 (79%) | 0.004 |
| Heparin | 103 (68%) | 35 (76%) | 68 (64%) | 0.12 |
| Azathioprine | 8 (5%) | 4 (9%) | 4 (4%) | 0.24 |
| IVIG once per months | 6 (4%) | 2 (4%) | 4 (4%) | 1.0 |
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| ||||
| aPL positive at screening # | ||||
| LAC | 81 (55%) | 36 (80%) | 45 (45%) | 0.0001 |
| aCL IgG | 90 (60%) | 30 (67%) | 60 (58%) | 0.30 |
| aCL IgM | 29 (19%) | 5 (11%) | 24 (23%) | 0.09 |
| aβ2GPI IgG | 59 (40%) | 20 (45%) | 39 (38%) | 0.36 |
| aβ2GPI IgM | 26 (18%) | 8 (18%) | 18 (17%) | 0.90 |
Characteristics are expressed as number (% of available data) unless otherwise noted. Proportion of missing data is <10% for all variables.
Chi-Square or Fisher exact or Mann Whitney tests compared patients with APOs to patients without APOs.
Age is expressed as mean (Standard Deviation).
APL positivity for each test was defined as: lupus anticoagulant : RVVT, dilute TTI or PTT LA with confirmation; aCL: IgG ≥40 GPL units; IgM ≥40 MPL units ; and anti-β2GPI: IgG ≥40 GPL units; IgM ≥40 MPL units. To be considered postive, each test met these criteria at least twice between 6 weeks and 5 years apart one of which must be in a core lab during the PROMISSE pregnancy (4).
Abbreviations: APOs: adverse pregnancy outcomes; BMI: body mass index; SLE: systemic lupus erythematosus; APS: antiphospholipid syndrome; aPL: antiphospholipid antibodies; IVIG: intravenous immunoglobulin therapy; LAC: lupus anticoagulant; aCL: anticardiolipin antibodies; aβ2GPI: anti-β2 Glycoprotein I antibodies; T1: first trimester of pregnancy; IU: international unit.