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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[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38.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: Zatuchni GI, Goldsmith A, Shelton JD, Sciarra JJ, ed. Long-acting contraceptive delivery systems. Philadelphia, Pa., Harper and Row, 1984. 621-7. (PARFR Series on Fertility Regulation)Progestasert (Alza Corporation, Palo Alto, California) achieves relatively high rates of contraceptive effectiveness through the release of a sex hormone--progesterone. Currently, it is recommended that Progestaserts be replaces every 12 months and most copper-bearing IUDs, every 3 years. To improve on Progestasert's 1-year replacement interval, Alza Corporation modified the Progestasert by increasing the amount of pregesterone contained in the IUD (from 38 to 52 mg) without changing the average daily release of 65mg. This long-acting progestasert, called the Intrauterine Progesterone Contraceptive System (IPCS), was designed to have a useful life of 3 years before replacement was required. The IPCS is identical in appearance to the Progestasert, and its contraceptive action in the same as that of the Progestasert. The effectiveness of either is through the effects of an intrauterine foreign body and through the effects of the progesterone on the encometrium. The IPCS system was designed to provide maximum contraceptive protection over a 3-year period and to reduce IUD-related bleeding, pain, and expulsion problems. Results from Alza monitored trials of the IPCS in the US and Mexico indicate that the cumulative life-table pregnancy rate increased from 3.6/100 women after 25 to 30 months of use to 10.6/100 women after 30 to 36 months of use. Laboratory evaluations of removed IPCS devices indicates that after 30 months of IPCS use the release rate of progesterone may not be adequate to prevent pregnancy effectively. The World Health Organization (WHO) evaluated the IPCS in 2 multiclinic studies. Postinsertion complications and complaints for the IPCS and T Cu-200 are shown. The include cervical perforation, ectopic pregnancy, pelvic inflammatory disease, dysmenorrhea, bleeding, spotting, and pelvic pain. The IPCS seemingly offers no particular advantages for use in developing countries.