A 5-year comparative study of efficacy and acceptability of three different sizes of TCu380Ag and TCu380A intrauterine devices.

BACKGROUND: The intrauterine contraceptive device TCu380Ag when compared with TCu380A at 1 year of use had better acceptability and continuation rates. OBJECTIVES: To study the continuation rate, efficacy, and acceptability of TCu380Ag in three sizes versus TCu380A at 5 years of use. METHODS: A total of 600 women opting for intrauterine contraceptive devices were randomized equally into two groups. Group 1 received the TCu380Ag device (Normal, Maxi, and Mini for uterocervical length 7-8.5 cm, 8-9 cm, and 6-7.5 cm, respectively) and Group 2 received the TCu380A device. Follow-up was performed at 5 years to assess efficacy, acceptability, and continuation. Frequency data comparisons was performed across categories using χ2 /Fisher exact test. RESULTS: At 5 years of use, Kaplan-Meier survival analysis showed that TCu380Ag compared with TCu380A had a higher continuation rate (45% vs. 35%, P = 0.010) with 100% efficacy each. TCu380Ag had fewer side effects, including heavy menstrual bleeding (16.6% vs. 34.1%, P < 0.001), abdomen pain (12.1% vs. 23.0%, P = 0.001), and expulsions (4.4% vs. 8.7%, P < 0.050), and fewer discontinuations attributable to contraceptive side effects (42.7% vs. 56.9%, P = 0.012). The mini TCu380Ag had the highest continuation rates and least menstrual irregularity (P < 0.050). CONCLUSIONS: The TCu380Ag device in three sizes is an alternative to TCu380A for women desiring 5 years of contraception with equal efficacy, better continuation, and acceptability. The mini size is preferred for women with a uterocervical length of 6 to 7.5 cm.