This retrospective study was designed to analyze the safety and efficacy of β-sympathomimetic agents used to treat premature labor in insulin-dependent diabetic women. The study evaluated 12 insulin-dependent diabetic women who experienced 15 pregnancies complicated by premature labor. A group of 30 insulin-dependent diabetic women who delivered at term served as matched controls. Treatment consisted of parenteral and oral administration of β-sympathomimetic drugs (ritodrine and isoxsuprine). Premature labor was diagnosed, and tocolytic treatment was initiated at a mean gestational age of 31.5 ± 0.9 weeks. The mean gestational age at the time of delivery was 35.8 ± 0.5 weeks. Delivery was delayed in the study group by a mean of 30.5 ± 6.6 days. No fetal or infant deaths occurred in the study group, and there was no difference between the two groups in the incidence of neonatal morbidity. No maternal complications occurred. There were no significant differences in hemoglobin A, levels between the two groups at any period of gestation. Thus, β-sympathomimetic drugs may be used safely to treat premature labor in patients with insulin- dependent diabetes, provided they are administered under strictly controlled clinical settings.