A random sequential comparative study of three models of the Copper T intrauterine contraceptive device (IUD) was undertaken in 1,792 women. For 7 months, the TCu 300 and TCu 220C were randomly inserted, and then the TCu 380A and 220C were randomly inserted for the next 12 months. The log-risk method of life-table analysis of event rates was performed at the end of each of the first 3 years of use of each device. The TCu 380A had the lowest pregnancy rate during each year of use, although the difference was not significant. At the end of each of the first 2 years, the TCu 300 was removed significantly less than the TCu 220C and TCu 380A for bleeding and pain. At the end of three years, the rates of removal for bleeding and pain for the TCu 380A and TCu 300 were similar and lower than that for the TCu 220C, but the overall difference was not significant. There were no differences among the devices for any other relevant use-related reasons. The TCu 380A was removed for other medical reasons significantly more frequently than the other devices at the end of 2 and 3 years. Adjusting for parity did not alter the results. The findings of this study suggest that the copper sleeves along the horizontal arms together with copper wire on the vertical arm in the TCu 380A model provide greater protection against intrauterine pregnancy, whereas the copper sleeves along the vertical arm as in the TCu 220C caused increased removals for bleeding and pain. The TCu 380A should be studied in a larger number of patients for a longer period of time to determine its clinical effectiveness. It may become the IUD of choice for all women irrespective of parity.
PIP: A sequential study analyzed 1792 women randomly using 3 different Copper T IUDs. The TCu 220C with a 30 sq. mm. sleeve on each horizontal sleeve and 5 sleeves on the vertical arm was inserted in 903 women. The TCu 380A with a copper sleeve on each horizontal arm and wound copper on the vertical arm was inserted in 391 women, while 498 women used the wound copper wire TCu 300. The TCu 380A produced the lowest pregnancy rate, but the difference in pregnancy rates for the 3 devices was not statistically significant. The TCu 300 had the lowest cumulative termination rate for expulsion, pain, and bleeding, but it was not significantly lower than the other 2 IUDs by 3 years after insertion. Since the horizontal and vertical sleeves of the TCu 220C are less flexible it is possible they produce a downward displacement with uterine contractions resulting in increased bleeding and pain. It may also account for the increased pregnancy rate and rate of removal of the TCu 220C. Other long-term, large-scale evaluations should be made to confirm that the TCu 380A, with an 8-year lifespan, has the low pregnancy and removal rates found in this study.