We evaluated factors associated with fetal losses in patients with sev
ere lupus in a nested case-control study. We assessed separately 73 pr
egnancies that occurred in 46 women from a cohort of 633 Systemic Lupu
s Erythematosus (SLE) patients. They had at least one pregnancy after
SLE diagnosis, one or more of our severity criteria and all had taken
immunosuppressive drugs. Included data were related to disease severit
y, anti-phospholipid syndrome (APS), anticardiolipin antibodies (a-CL
ab), and drugs received during pregnancy. Cases were pregnancies with
fetal wastage; controls were pregnancies with live-born children. The
mean age at pregnancy was 26.6 +/- 4.5 years. Cases had longer disease
duration, 6.1 +/- 3.5 years vs 4.5 +/- 4.3 of controls (p = 0.02); hi
gher prevalence of renal involvement, hemolysis and recurrent venous t
hrombosis (p < 0.05); they also tended to have a greater prevalence of
a-CL ab, and previous fetal losses (p = 0.06). Cases used azathioprin
e more frequently than controls (p = 0.04). Univariate analysis showed
an association of renal involvement, hemolytic anemia, azathioprine o
r cyclophosphamide prescription during pregnancy, previous fetal losse
s and APS with fetal wastage. Immunosuppressive drugs and the APS rema
ined significant in the multivariate analysis (p = 0.05; F = 0.01). Fa
ctors related with fetal losses in women with severe SLE were: longer
disease duration, ingestion of immunosuppressive drugs during pregnanc
y and any related manifestation of APS. We did not find macroscopic ma
lformations in live-children of women that took azathioprine during pr
egnancy.