EFFECTIVENESS, SAFETY, AND ACCEPTABILITY OF A COPPER INTRAUTERINE-DEVICE (CU SAFE-300) IN TYPE-I DIABETIC WOMEN

OBJECTIVE - To evaluate the long-term effectiveness and safety of a co pper intrauterine device fulfilling modem 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 1 2 +/- 8 yr, HbA1c 7.0 +/- 1.2%, 78% nulliparous women) were prospectiv ely evaluated at 3, 6, 12, 24, and 36 mo by a gynecological exam and a standardized questionnaire after insertion of die intrauterine device (CU Safe 300, 300 mm2 of copper). A group of nondiabetic women (n = 1 150) of comparable age and parity evaluated according to the same stud y 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 lst yr (691 women-mo) were one accident al pregnancy, one expulsion, one removal for pain, two removals for bl eeding, and one removal for planned pregnancy. Events during the 2nd ( 593 women-mo) and 3rd yr (470 women-mo) were zero and one accidental p regnancy, one and two removals for bleeding, one and one removal for p ain, one and one removal for other medical reasons, and two and two re movals for planned pregnancy, respectively. No case of pelvic inflamma tory disease was diagnosed in the diabetic group, and one case was dia gnosed in the nondiabetic group (28,369 mo of cumulative use). Events leading to termination of the intrauterine device per women observed p er year and continuation with the intrauterine device after each year of use were comparable in the diabetic and nondiabetic groups for the lst, 2nd, and 3rd yr. CONCLUSIONS - These results, although preliminar y because <100 diabetic women were studied, indicate that the intraute rine device CU Safe 300 is as effective, safe, and well-tolerated in d iabetic as in nondiabetic women. Specific objections to the use of int rauterine devices in type I diabetic women do not seem to be justified for modem, copper-medicated models.