Randomized study of subcutaneous low molecular weight heparin plus aspirin versus intravenous immunoglobulin in the treatment of recurrent fetal loss associated with antiphospholipid antibodies.
OBJECTIVE
To compare the 2 most efficacious therapeutic regimens, intravenous immunoglobulin (IVIG) and anticoagulation with low molecular weight (LMW) heparin plus low-dose aspirin, in women with recurrent pregnancy loss associated with antiphospholipid antibodies (aPL).


METHODS
We examined 40 women with recurrent abortion (at least 3 occurrences) and repeatedly positive test results for anticardiolipin or lupus anticoagulant. The subjects were randomly assigned to treatment with IVIG or LMW heparin plus low-dose aspirin. Both therapies were started when the women were pregnant as documented by a positive urine test. IVIG was stopped at the thirty-first week of gestation, aspirin at the thirty-fourth week, and heparin at the thirty-seventh week. The primary outcome of interest was the rate of live births with the 2 treatments.


RESULTS
The characteristics of the 2 groups were similar at the time of randomization. The women treated with LMW heparin plus low-dose aspirin had a higher rate of live births (84%) than those treated with IVIG (57%).


CONCLUSIONS
Treatment with LMW heparin plus low-dose aspirin should be considered as the standard therapy for recurrent pregnancy loss due to aPL.
Triolo
Giovanni
G
Cattedra di Reumatologia, Istituto di Clinica Medica, Policlinico and University of Palermo, Palermo, Italy. triolog@tiscalinet.it
Ferrante
Angelo
A
Ciccia
Francesco
F
Accardo-Palumbo
Antonina
A
Perino
Antonino
A
Castelli
Antonio
A
Giarratano
Antonio
A
Licata
Giuseppe
G
D000026:Abortion, Habitual / Q000209:etiology / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D016736:Antiphospholipid Syndrome / Q000150:complications / Q000188:drug therapy*; D001241:Aspirin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D011247:Pregnancy; D011248:Pregnancy Complications; D011256:Pregnancy Outcome; D011897:Random Allocation; D016896:Treatment Outcome
D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D016756:Immunoglobulins, Intravenous; D001241:Aspirin