Objective: To evaluate the efficacy of low-dose intravenous immunoglobulin (IVIG) treatment in older women with immunologic abnormalities and recurrent spontaneous abortion (RSA), a condition referred to as immunologic abortion.
Design: Prospective clinical trial.
Setting: Outpatient referral practice.
Patient(s): Forty-seven women were enrolled in the study. The mean age of the women was 37 years (range, 28-45 years), and the mean number of prior miscarriages was 3.7. Immunologic abnormalities included antiphospholipid antibodies (32%), antithyroid antibodies (53%), antinuclear antibodies (28%), antiovarian antibodies (2%), increased natural killer cells (40%), increased immunoglobulin (Ig)M level (28%), and increased CD4/CD8 T-cell ratio (15%). One patient had IgA deficiency, and three women had endometriosis. Thirty-one of the 47 patients (66%) had more than one immunologic abnormality.
Intervention(s): Treatment with IVIG at a dose of 0.2 g/kg within 2 weeks of attempted conception. Once conception was achieved, IVIG treatment was continued on a monthly basis at the same dose through 26-30 weeks of gestation.
Main outcome measure(s): Successful pregnancy or recurrent abortion.
Result(s): Of the 47 women, 36 received initial IVIG treatment, and 24 subsequently became pregnant. Of these women, 20 continued IVIG treatment through 26-30 weeks of gestation, and 19 (95%) had a successful term pregnancy. Four women discontinued IVIG therapy after 10-12 weeks of gestation, and 3 (75%) had a successful pregnancy outcome. Of the 11 women who refused IVIG therapy, 7 became pregnant, and all 7 miscarried. The difference in pregnancy success rate between the IVIG-treated and untreated groups was significant (P=.001). Three women had adverse reactions during the low-dose IVIG infusion, and these reactions resolved when the IVIG brand was changed. Fetal abnormalities were not observed.
Conclusion(s): Low-dose IVIG therapy is beneficial for older women with immunologic abortion. The optimum duration of IVIG treatment in these women requires further study.