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  • Title: [The TCu380 IUD: initial international experimental results with the latest "T" family IUD].
    Author: Elia D, Belaisch J.
    Journal: Contracept Fertil Sex (Paris); 1985 Sep; 13(9):973-8. PubMed ID: 12267501.
    Abstract:
    The Gyne T 380 IUD is similar to the Gyne-T 200 available in France since 1979 except that it contains a ball on the extremity of the vertical arm designed to prevent cervical perforation and it has a higher copper content. A multicenter study found cumulative annual event rates/100 women for the Gyne T 200 and the Gyne T 380 respectively of 4.9 and .7 for pregnancy, 10.1 and 6.8 for expulsion, 13.7 and 21.5 for removal because of pain or bleeding, 4.9 and 4.3 for removal because of other medical reason, and 5.9 and 10.4 removal to achieve pregnancy. The continuation rates were 54.9 and 50.1, while number of months of utilization were 82,800 for the Gyne T 200 and 17,652 for the Gyne T 380. An American study of 3536 insertions of the Gyne T 380 showed rates after 1, 2, and 3 years of use respectively of .7, .8, and 1.1 for pregnancy, 5.5, 7.5, and 8.5, for expulsion, 13.1, 21.8, and 26.7 for removal because of pain or bleeding, 3.0, 4.6, and 5.4 for removal for other medical reasons, and 73.0, 53.7, and 41.1 for continuation. 68.2% of participants in the American study were under 25 and 63.7% were nulliparas. Additional data after 4 years of use of the Gyne T 380 showed a cumulative net pregnancy rate of 1.9. The risk of extrauterine pregnancy was estimated at .38/1000 women after 3 years. The frequency of expulsions appeared to be negatively connected with age and parity. Rates of removal for pain or bleeding appeared to be negatively correlated with age. In the comparative study, rates of removal for pain or bleeding were higher in nulliparas. Most medical reasons for removal other than pain or bleeding referred to pelvic inflammations, salpingitis, endometritis, or vaginitis, and their frequency declined after the 1st 6 months of use. Continuation rates were identical for the Gyne T 380 and for the other T devices in the American study. Among 293 women requesting removal of the device for pregnancy, 78.4% became pregnant within the next 12 months. 1767 women in the American study had Pap smears before and during Gyne T 380 use; the proportion in classes III and IV did not change after insertion of the device. 2 Indian studies demonstrated no neoplasic transformations or aggravations of dysplasic lesions. Analysis of a small number of randomly selected Gyne T 380 IUDs removed for study showed an average release during the 1st year of 50.3 mcg/day of copper, varying from 17.5 to 63.9 mcg in 8 of the 9 devices. The rate declined with time and was half as high in the 3rd and 4th years. Fragmentation of the copper wire apparently is less frequent in the Gyne T 380 than in the Gyne T 200. The location of the copper wires on both horizontal arms may explain the greater contraceptive efficacy of the Gyne T 380.
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