Prolonged intrauterine contraception: A seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS

Abstract

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.

Partial and complete expulsion of the Multiload 375 IUD and the levonorgestrel-releasing IUD after correct insertion

“…Only 20% of all expulsions occurred more than 1 year after insertion. This observation is in accordance with previous trials evaluating the expulsion rate of copperdevices [15,17]. Predictors of copper-IUD expulsions are young age, excessive length of the endometrial cavity, reinsertion after expulsion, nulliparity and heavy menstrual flow [2,13,19,20].…”

“…There are two other explanations for the different results. First, in our study, the number of dislocations is higher for both IUD types, because using transvaginal ultrasound, we did not only identify complete expulsions, but although partial expulsions [15,17,18]. This assumption is supported by the results of Petta et al [3], who performed a sonographic follow-up of 235 women with a CuT 380Ag for 12 months.…”

“…Diaz et al [20] found an increased risk for dislocations in parous adolescents. The expulsion rate for the LNG-IUD has been reported to be slightly increased in women younger than 25 years [15]. Age did not have an influence on the dislocation rate in our study, probably because we usually do not insert IUDs in adolescents in our clinic and the youngest participant in our study was 23 years old at enrolment.…”

“…This rate is somewhat lower compared to our 1 year data and distinctly higher than in studies without ultrasonographic monitoring of the IUD position. Second, difficult insertions were noted more frequently for the LNG-IUD in the study of Sivin et al [15]. Because it was not evaluated whether those IUDs were in the correct position, we hold the view that at least some of the expulsions have been due to insertion failures.…”

“…Transvaginal ultrasound can be used to identify the correct IUD position in the uterus cavity. The expulsion rate of the LNG-IUD has been reported to be higher in comparison with third generation copper-IUD in studies not monitoring the correct device position with ultrasound [9,15]. Both studies were not primarily designed to evaluate the number of partial or complete expulsions.…”