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A randomized comparative study of interval insertion of three intrauterine devices: the copper T 220c, the Nova T and the WHO levonorgestrel 2 ug IUD.
[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38. All have had at least 1 full-term delivery. Subjects were randomly allocated to 1 of the 3 IUDS: the Copper T 220C (Tcu 220c), the Nova T, and the World Health Organization levonorgestrel 2 ug IUD. Insertion was done from the 3rd to the 5th day of menstruation between Feb. and Sept. 1984 and followed up at 48 hours, 3, 6, 12, and 24 months after IUD insertion. 12 month data was collected for cumulative rates, based on life table procedures and analyzed with log-rank test. There was no loss to follow up and no insertion failure. All levonorgestrel IUDs have been removed because the levonorgestrel-releasing IUD has a relatively high risk of ectopic pregnancy. The use-related discontinuation rates of Tcu 220c, Nova T, and levonorgestrel IUD during 12 months of use, were 11.1, 2.4, and 12.7, respectively. The difference between Tcu 220c and Nova T were statistically significant (p.<0.01). The continuation rates of Tcu 220c, Nova T, and levonorgestrel during 6 months of use were 94.0, 99.0, and 96.0, respectively. During 12 months of use, they were 88.9, 97.6, and 87.3 respectively. 1 ectopic pregnancy occurred with the levonorgestrel IUD after 7 months of use. No pregnancy occurred in Nova T users. The pregnancy rates of Tcu 220c and levonorgestrel IUD during 12 months of use were 1.0 and 1.3, respectively. Removal rates for bleeding with Tcu 220c and levonorgestrel IUD during 12 months of use were 3.1 and 1.0, respectively. The removal rate for pain with Tcu 220c during 12 months of use was 2.0. The duration of bleeding and spotting with 3 IUDs, 3, 6, 9, and 12 months of use are illustrated. Preliminary results show that the Nova T is superior to Tcu 220c and levonorgestrel IUDs. Expulsion is the main event in both Nova T and Tcu 220c. More attention should be paid to the insertion technique. The duration of bleeding and spotting of levonorgestrel IUD were longer in the last 3 months after insertion, but was shortest at 1 year of use when compared with Tcu 220c and Nova T.
In: Mishell, D.R., Jr., and Martinez-Manautou, J., eds. Clinical experience with the progesterone uterine therapeutic system. (Proceedings of the Acapulco Workshop, Acapulco, Mexico, October 15-16, 1976) Princeton, New Jersey, Excerpta Medica, 1978. p. 99-103In order to compare the efficacy and acceptability of the Progestasert progesterone-releasing IUD and the Gravigard Copper-7 device, 295 parous women randomly received the progesterone device (146) or the copper device (149). Follow-up examinations took place at 1, 3, 6, and 12 months postinsertion. It was found that event rates did not differ significantly between the progesterone (1569 women-months) and the copper (1558 woman-months) devices. Greater pain on insertion (23.3% versus 15.4%), less metrorrhagia (7.5% versus 13.4%), and higher continuation rates after 1 year of use (87.2% versus 84.6%) were associated with the progesterone device. A flow decrease of 27.2% and increase of more than 22.3% was associated with the Copper-7. Duration of menstruation was not significantly different between the 2 groups, but the progesterone IUD users had more days of "spotting." In both groups, duration of menstruation increased by the end of the study year for a large number of women. This was significant only in Copper-7 users.