Combined and national experience of postmenstrual IUD insertions of Nova-T and Copper-T in a randomized study.

A randomized comparative study between Nova-T and Copper-T-200 was performed simultaneously in Denmark, Finland and Sweden. The results of 741 postmenstrual insertions with Nova-T and 780 with Copper-T are reported. The pregnancy rate of Nova-T was lower in every age and parity group. The pregnancy rate of Copper-T-200 varied in participating countries, whereas the pregnancy rate of Nova-T was equally low in every country. The termination rate because of expulsion with Nova-T was less affected by age and parity than that of Copper-T. Significant differences in the continuation rates with the same device were found between countries. Removals because of infection showed that women below 25 years of age had a high risk for infection regardless of parity.     

A comparative study of the clinical performance of two copper-releasikg IUDs,NOVA-T & copper-T-200 in Lagos,Nigeria

A non-randomised study was performed to compare the use-effectiveness of the Copper-T-200 and Nova-T intrauterine devices. It was found that generally, results compared favourably with other world-wide studies. No accidental pregnancies were experienced and no significant difference was found between the expulsion rate of the Nova-T (5.0) and that of the Copper-T-200 (6.5) and the removal rates for bleeding and pain, which were 1.5 and 3.8, respectively. The continuation rate for the Nova-T was 91.3 compared with 88.2 for the Copper-T. The total experience was based on 815 woman-months of use.     

Randomized comparison of clinical performance of two copper-releasing IUDs, Nova-T and Copper-T-200, in Denmark, Finland and Sweden.

A randomized study was conducted simultaneously in three countries to compare the clinical performance of two new IUDs, the Nova-T and Copper-T-200. Forty-four persons, midwives, general practitioners, residents and specialists in obstetrics and gynecology inserted 907 Nova-Ts and 936 Copper-Ts. The pregnancy rate of Nova-T (0.7 at one year) was significantly lower than that of Copper-T (2.2 at one year). No significant differences were observed in other termination rates. The continuation rates were 72.6 for Nova-T and 71.3 for Copper-T-200. The total experience was based on 18,035 woman months of use, with a lost to follow-up of less than 7 per cent for both IUDs.     

Two-year clinical experience with Nova-T 380, a novel copper–silver IUD

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan–Meier method, were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4.7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9, planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpected serious adverse events were encountered.     

A randomized comparative study of three IUDs: Nova-T,MLCu375 and MLAgCu250 in New Zealand: 1-year results

A randomized comparative study was made in New Zealand of three models of copper IUDs, the Nova-T, MLCu375 and MLAgCu250, with interval acceptors. At 1 year, the Multiloads (MLs) had lower net termination rates for accidental pregnancy, expulsion, pain/bleeding, other medical removals and infections (use-related terminations) than the Nova-T. These rates were significantly lower for the MLAgCu250 than the Nova-T for accidental pregnancy, expulsion and infection. The MLCu375 had significantly fewer removals for pain/bleeding and for other medical removals than the Nova-T. The MLAgCu250 had a significantly lower accidental pregnancy rate than the MLCu375. The Multiloads had significantly higher relevant use-related continuation rates than the Nova-T.     

Clinical performance of the Nova-T380 IUD in routine use by the UK Family Planning and Reproductive Health Research Network: 12-month report

Doctors working in general practice and at family planning clinics throughout the UK who collaborate in the UK Family Planning and Reproductive Health Research Network were responsible for the fitting of 572 Nova-T380 intra-uterine contraceptive devices (IUDs). The Nova-T (and formerly the identical Novagard) IUDs have copper with a surface area of 200 mm(2). The device used in this study, the Nova-T380, has copper with a surface area of 380 mm(2). The purpose of the study was to evaluate the pregnancy and complication rates of this new device, with its increased area of copper, in comparison with other published results, in the clinical setting of British general practice and family planning clinics. The 12-month cumulative life-table event rates were: pregnancy 0.8, expulsion 5.6, removal for bleeding or bleeding and pain 11.0. The continuation rate was 73.4. The pregnancy rate at 12 months showed good contraceptive performance. The increased surface area of copper was not associated with a reduced pregnancy rate, but as this was not a direct comparative study with the Nova-T, the influence of the increased area of copper must remain somewhat uncertain. This study found the discontinuation rate for bleeding problems and pain with bleeding to be higher than in other published studies. Other event rates were consistent with other published studies.     

A comparative controlled trial in rural Thailand of three intrauterine devices

A controlled comparative trial of three intrauterine devices (the Lippes loop C, Antigon-F and Ypsilon devices), was undertaken in a rural area of Thailand. 2,452 insertions were performed, and a two-year follow-up period provided 2,946.4 woman-years of observation. The three treatment groups were fully comparable in terms of age, parity, open birth interval, previous contraceptive use and haematocrit level. Life table analysis showed that the Antigon-F had significantly lower expulsion rates than the other two devices, and that the Lippes C was associated with the highest risk of expulsion. The expulsion rates after two years were higher than has been generally reported in the literature (16.2, 31.8 and 25.1 per 100 women for the Antigon-F, Lippes C and Ypsilon, respectively). However, differences in the characteristics of the study populations, ethnic factors and follow-up procedures could explain this finding. The pregnancy rates were comparable for all three devices and in general the removal rates were also comparable. The Antigon-F had significantly higher continuation rates than the other two devices through 18 months. However, there was no significant difference in continuation rates between the three devices after two years of observation. Considerable variation was noted in the event rates for different insertion personnel.     

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.     

Comparative randomized study of the copper-T 200 and Dalkon Shield intrauterine devices.

The Dalkon Shield (DS) and the Copper-T 200 (CT) devices were randomly inserted in 1015 women (6477 woman-months) at the University of Florida family planning clinic in the 1st year of a study from 1972-1974. None of the event rates between the 2 devices reached significant difference. The pregnancy rates tended to be lower with the CT and the expulsion rates lower with the DS device. 2 uterine perforations occurred in the CT group, and 20 women developed acute pelvic infmalmatory disease associated with pregnancy, in DS users. Therefore, since the CT gives equally good performance rates, it should replace the DS in family planning practice.     

Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD.Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.     

Post-abortion insertion of the Copper T 200 and Lippes loop — A comparative study

Lippes loops and Copper-Ts were inserted in the first week after abortion to 705 and 639 women, respectively, as part of the routine work of a large Obstetrics Department in Santiago, Chile. The continuation rate after a year was better for the Copper-T (78.5) than for the Lippes loop (72.0), derived from lower expulsion (13.0 vs. 16.5) and medical removal rates (2.9 vs. 7.2). Pregnancy rate was higher for the Copper-T (3.5) than for the Lippes loop (2.6).     

Clinical performance of copper-T-200, multiload-250 and Nova-T: A comparative multicentre study

A randomized multicentre study of Copper-T-200 (CuT), Multiload-250 (ML) and Nova-T (NoT) was conducted to evaluate the clinical performance of these three IUDs in the hands of general practitioners with varying experience in the different insertion techniques. After 36 months of use a total of 19,821 treatment cycles was accumulated. The continuation rate was 69.7% for CuT, 60.9% for ML and 61.8% for NoT. The cumulative expulsion rate after 36 months was 5.0% and equally distributed among centres and types of IUD. Removal for medical reasons was 11.4% and also equally distributed among the centres and the types of IUD. The pregnancy rate was insignificantly higher for the NoT compared with the two other types.     

Comparison of the performances of TCu380A and TCu380S IUDs up to five years

A modification of the TCu380A IUD to create the model TCu380S was introduced many years ago. The TCu380S utilizes copper sleeves that are flush in the plastic and are set at both ends of the horizontal arm. The objective of this study is to compare the clinical performance of the TCu380A and the TCu380S IUDs, especially regarding contraceptive performance and expulsion, in a cohort of women who had one of these two devices inserted at random. This paper presents the results up to 5 years of use. A total of 1568 women were enrolled: 806 women received a TCu380A and 762 women received a TCu380S IUD. The performance was evaluated by life-table analysis and significance between rates was tested by the method of log-rank. The cumulative pregnancy rate was low in users of both models of IUD but lower in users of the TCu380S model through the 5 years of use, without statistical significance. Expulsion was significantly higher in users of the TCu380S model during the five years of use. The other reasons for discontinuation were similar for both devices and did not show statistical significance. The continuation rate was significantly lower in users of the TCu380S model in the first and second years of use. Both devices presented a very low pregnancy rate and TCu380S presented a lower pregnancy rate than the TCu380A, although without statistical significance.     

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.     

Factors associated with discontinuation rates of the Copper T380A IUD in a Peruvian public hospital

The objectives of this study were to evaluate performance and causes of discontinuation of the Copper T380A IUD by users at the Family Planning Service at Hospital Arzobispo Loayza in Lima, Peru, during a period of three years. The study included 3167 acceptors of the CuT380A attending the service during 1992-1994. IUDs were inserted during interval timing. Follow-up was at 1, 12, 24 and 36 months after insertion. The following events were recorded: number of pregnancies, expulsions and all causes of discontinuation. The cumulative rates per 100 woman-years using the life-table method was calculated. Also calculated were the relative risks for expulsion and for pregnancy. At the end of the study, 361 women had discontinued the method for various reasons, whereas 1667 women continued using the method. The lost-to-follow-up proportion increased over time from 35.9 per 100 woman-years for the first year to 38.2 for the third year. The cumulative discontinuation rate over three years was 22.6±1.3 (cumulative rate±standard error) per 100 woman-years. The cumulative pregnancy rate for three years was 1.2±0.4 per 100 woman-years, whereas the cumulative rate of expulsion was 4.9±0.4 for the first, 6.4 for the second and 6.8 for the third year. The main cause of discontinuation during the first year of use was expulsion (4.9 per 100 woman-years) followed by personal reasons (2.1 per 100 woman-years). At the end of the third year, the main cause was personal reasons (11.4) and the second cause was expulsion (6.8). A higher probability of expulsion, pregnancy and discontinuation for bleeding and/or pain was associated with age less than 20 years. In conclusion, the effectiveness of the CuT380A IUD after three years of use was 98.8 per 100 woman-years, whereas continuation was 39.2, and loss to follow-up increased over time.     

The multiload IUD--a U.S. researcher's evaluation of a European device.

This evaluative review focused on the performance and safety of the Dutch-made Multiload copper IUD, primarily the Multiload-375 (MLCu-375) model which has a longer life expectancy (5 or more years) than the Multiload-250 (MLCu-250) model, usually cited for a life expectancy for three years. This copper-medicated IUD differs from the copper-T IUDs in shape and insertion technique. The review shows that (a) the MLCu-375 IUD seems to be slightly less effective in preventing pregnancies than TCu-380A IUD. Its efficacy is comparable to that of the Nova-T by two to three years of use; (b) the MLCu-250 IUD is similarly effective to TCu-200 but may be slightly less effective than TCu-220C; (c) no consistent differences were detectable in expulsion rates or in removal rates for bleeding/pain between the Multiload IUDs and comparative Copper-T IUDs; (d) the Multiload IUDs may perform better in nulliparous women than the T-shaped devices; (e) no or a very low incidence of uterine perforation is associated with insertions of the Multiload IUD; (f) ectopic pregnancy risks are similarly low in Multiload IUD users as in Copper-T-380A users; and (g) pelvic inflammatory disease (PID) risks are similarly low in Multiload IUD users as in users of T-shaped copper IUDs.     

Efficacy and continuation rates of Norplant in Pakistan.

A total of 265 women who had the Norplant system inserted were followed for 5 years. The present study is based on 11,435 women-months of use, describing the continuation rates and efficacy of Norplant among these women. The 5-year cumulative continuation rate was 45.7 per 100 continuing users. The continuation rates were age-dependent. The women > or = 35 years of age consistently maintained higher continuation rates at all time intervals as compared with those of younger women. During 5 years of follow-up, five women became pregnant. Three pregnancies occurred in year 2, one in year 3, and one in year 5. The 5-year cumulative pregnancy rate was 2.5 per 100 continuing users. The weight of the user did not influence the pregnancy rate. The continuation rates, as well as the pregnancy rates, are comparable to those reported from other countries in the region.     

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.     

3种宫内节育器临床避孕效果随访1年观察

目的观察GyneFix IN IUD、MCu IUD、TCu220C IUD的临床避孕效果。方法2003年6月~2006年6月本院采用对比性研究,以随机方法放置3种IUD635例,其中GyneFix IN IUD 212例,MCu IUD213例,TCu220C IUD 210例,于放置后1、3、6、12个月进行随访。结果3种IUD12个月的带器妊娠率、脱落率、因症取出率和累积续用率分别为GyneFix IN IUD0.47%,0.94%,0.47%,98.11%;MCu IUD0.94%,0.94%,1.41%,96.24%;TCu220C IUD0.95%,5.71%,4.29%,88.10%。3种IUD带器妊娠率比较,差异无显著性意义(P>0.05);GyneFix IN IUD和MCu IUD的脱落率低于TCu220C IUD,差异有非常显著性意义(P<0.01);GyneFix IN IUD和MCu IUD的因症取出率低于TCu220C IUD,差异有显著性意义(P<0.05);GyneFix IN IUD和MCu IUD的12个月的累积续用率高于TCu220C IUD,差异有非常显著性意义(P<0.01)。结论GyneFix IN IUD和MCuIUD具有脱落率低、因症取出率低、累积续用率高的优点,值得临床应用。根据对象的自身条件,选择合适的IUD,可提高避孕效果,减少副反应的发生。     

Five years private practice experience of nulliparous women using copper IUD's

This is a study of 296 nulliparous women who used Copper IUD's as their method of contraception. At the time of first insertion the women had an average age of 21.6 years. The gross cumulative pregnancy rate rose to 11.8 over 5 years. The gross cumulative expulsion rate rose to 13.6 over 5 years and the removal rate for bleeding and pain to 20.4. The net rates were lower over 5 years (pregnancy 8.6, expulsion 11.2 and bleeding and pain 17.3). 29 women expelled their IUD's, of whom 20 underwent reinsertion. 43 women requested removal of their IUD's because of bleeding and pain, of whom 6 requested a reinsertion at a later date. Taking reinsertions into account, the continuation rate over 5 years was 55.2. Inability to insert the IUD was encountered in 28 women (8.6%). In 20 of the women cervical stenosis precluded the insertion of the IUD without local anesthetic, and in the other 8, the pain and/or syncope encountered during sounding the uterus precluded the continuation of the procedure. Insertion problems were encountered in 31 women (10.5%). Syncope occurred in 4 women and one of the women developed a ‘grand mal’ seizure. Clinically significant pelvic infection occurred within 30 days of insertion in 5 women (approximately 1% of insertions), and one woman developed pelvic infection from gonorrhoea.