Effectiveness, Safety, and Acceptability of a Copper Intrauterine Device (CU Safe 300) in Type I Diabetic Women

Abstract

Objective— To evaluate the long-term effectiveness and safety of a copper intrauterine device fulfilling modern standards in type I diabetic women compared with nondiabetic women. Research Design and Methods— Type I diabetic women (n = 59, age 27 ± 5 yr, duration of diabetes 12 ± 8 yr, HbA1c 7.0 ± 1.2%, 78% nulliparous women) were prospectively evaluated at 3, 6, 12, 24, and 36 mo by a gynecological exam and a standardized questionnaire after insertion of the intrauterine device (CU Safe 300, 300 mm2 of copper). A group of nondiabetic women (n = 1150) of comparable age and parity evaluated according to the same study protocol served as a control group. Results— In the diabetic women (1754 cumulative months of use), events leading to termination of the intrauterine device during the 1st yr (691 women-mo) were one accidental pregnancy, one expulsion, one removal for pain, two removals for bleeding, and one removal for planned pregnancy. Events during the 2nd (593 women-mo) and 3rd yr (470 women-mo) were zero and one accidental pregnancy., one and two removals for bleeding, one and one removal for pain, one and one removal for other medical reasons, and two and two removals for planned pregnancy, respectively. No case of pelvic inflammatory disease was diagnosed in the diabetic group, and one case was diagnosed in the nondiabetic group (28,369 mo of cumulative use). Events leading to termination of the intrauterine device per women observed per year and continuation with the intrauterine device after each year of use were comparable in the diabetic and nondiabetic groups for the 1st, 2nd, and 3rd yr. Conclusions— These results, although preliminary because < 100 diabetic women were studied, indicate that the intrauterine device CU Safe 300 is as effective, safe, and well-tolerated in diabetic as in nondiabetic women. Specific objections to the use of intrauterine devices in type I diabetic women do not seem to be justified for modern, copper-mediated models.