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PubMed2002

Factors leading to the removal of the intrauterine implant Gynefix.

OBJECTIVE: The objective of this study was to determine the incidence of expulsion of the Gynefix intrauterine implant, to analyze the variables associated with the above and to examine the efficacy of this intrauterine contraceptive model in users at the Municipal Family Planning Center-SERGAS in A Coruña, Spain. METHODS: A prospective observational study was performed on all women (n = 358) who had a Gynefix implant inserted from March 1998 to September 2000. RESULTS: The accumulated incidence of implant expulsion was 6.7% (95% confidence interval (CI) 4.4-9.9) with a pregnancy rate of 0.6% (95% CI 0.09-2.2). The probability of implant removal decreases with the rise in the number of implants that have been inserted by the professional. A multivariate analysis adjusted for age, number of implants and uterine position showed that the position of the uterus was the variable that independently determined the probability of removal. CONCLUSIONS: It is concluded that retroflexion of the uterus increases the probability of removal.

Adolescent↗
PubMed1989

Comparison of copper T-200 with Lippes loop as a contraceptive device.

A comparison has been made between Lippes loop and T Cu 200 intra-uterine contraceptive device with respect to their acceptability and effectiveness in a developing country. A total of 1054 patients were studied; 697 with Lippes loop and 357 with T Cu 200. The ages of the patients ranged between 14 and 44 years, with a peak age of 21-25 years for T Cu 200 and 26-30 for Lippes loop. The event rates were similar but T Cu 200 displayed lower expulsion rate, lower intermenstrual bleeding rate and a lower incidence of pelvic inflammatory disease. The Lippes loop had lower event rate for the other parameters considered, pregnancy and pelvic pain. The continuation rate was similar for both devices. Both devices are useful for women who wish to space out their children but for those who wish to achieve effective contraception for more than 5 years, Lippes loop should be the IUD of choice.

Barium Sulfate↗
PubMed1999

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.

Adolescent↗
PubMed1980

[Comparison of intra-uterine devices, Copper-T-200 and Dana-Super-Fix-Cuprum (author's transl)].

The two above IUDs were compared by application to 411 patients, with the Copper-T 200 being used on 239 and the Dana-Super-Fix-Cuprum on 172. Gravidity occurred to 2.9 or 5.8 per cent of all probands. The Pearl indices were 2.6 or 4.2. Spontaneous expulsion was observed in 2.5 or 3.5 per cent of all cases. Devices had to be extracted from 9.6 or 11.6 per cent of the patients. Adnexitis was diagnosed in 0.4 or 1.7 per cent of the cases. Continuity values were 85.0 per cent for the Copper-T-200 and 79.1 per cent for the Dana-Super-Fix-Cuprum. No substantial difference in effectiveness was found to exist between the two above copper-based intra-uterine devices.

Adolescent↗
PubMed1975

Randomized comparative study of the copper T 300, Dalkon shield, and Shell Loop in parous women.

A randomized comparative study of the Copper T 300, the standard Dalkon Shield and the Silicone Shell Loop D was conducted on 776 parous women. Net cumulative first event rates at 1 year and at 18 months, calculated by life-table analysis, were as follows: Copper T 300--pregnancy 1.2/1.9, expulsion 6.4/7.0, removal for pain or bleeding 7.4/10.8; Dalkon Shield--pregnancy 2.7/4.5, expulsion 5.8/5.8, removal for pain or bleeding 7.7/14.7; Shell Loop--pregnancy 3.8/4.9, expulsion 0.5/0.5, removal for pain or bleeding 9.1/13.1. None of the differences in event rates, except the lower expulsion rate of the Shell Loop, were significant. The continuation rates for the three devices at both 12 and 18 months were similar, indicating that there was little difference in their performance. As the results of this study showed a similarity of the incidence of events among very differently disigned IUD's, previously reported differences in performance of these and possibly other types of IUD's may very likely be more related to differences among clinics than to differences among the devices themselves.

Adolescent↗
PubMed1992

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.

Evaluation Studies as Topic↗
PubMed1988

Fifteen years' experience with the Multiload IUD.

The Multiload IUD with an exposed copper surface area of 250 mm2 (MLCu250) was developed in 1972 and has become one of the most widely used IUDs. Modifications to the MLCu250 include an increase in the area of exposed copper wire to 375 mm2 (the MLCu375) and an increase in the diameter of copper wire from 0.3 to 0.4 mm. The Multiload has been evaluated extensively in noncomparative and comparative clinical trials. In these latter studies the MLCu250 performed better than the Cu-7 and TCu-200, and the MLCu375 performed better than the Fincoid or Nova T and about equally as well as the TCu380. Pooled data from over 26,000 insertions of the MLCu250 gave the following 3-year cumulative event rates (per 100 women): pregnancy, 2.0; expulsion, 3.1; removal for pain/bleeding, 7.1. Comparative studies of the Multiload and other IUDs have shown all IUDs in current use are associated with similar rates of pelvic inflammatory disease. IUDs such as the MLCu375 that have larger copper surface areas appear to be associated with lower ectopic pregnancy rates. Follow-up studies of women who have had their Multiloads removed indicate that use of the device does not impair future fertility or affect pregnancy outcome. All IUD users, regardless of the type of IUD used, are at risk of complications. On balance, the benefits of IUD usage far exceed the associated risks.

Clinical Trials as Topic↗
PubMed1991

A comparative clinical trial of the TCu 380A, Lippes Loop D and Multiload Cu 375 IUDs in Indonesia.

The Copper T 380A (TCu 380A), Lippes Loop D (LLD) and the Multiload Cu 375 (MLCu 375) IUDs were evaluated for safety and efficacy in a multicenter randomized clinical trial in Indonesia. A total of 2992 women were enrolled into the study and data for 2845 women were analyzed (147 cases did not meet protocol criteria). Although study IUDs were randomly assigned, LLD users in this study were older and of higher parity than TCu 380A and MLCu 375 users. The 24-month gross cumulative life-table pregnancy rates for TCu 380A, LLD and MLCu 375 users were 1.2, 2.2 and 2.7, respectively. The 24-month expulsion rates for TCu 380A, LLD and MLCu 375 users were 6.7, 7.5 and 5.3, respectively. Overall, 24-month continuation rates were 85.5%, 85.0% and 85.4% for the respective device groups. Differences in both gross and age- and parity-adjusted life-tables rates for the major outcome variables were not statistically significant at 24 months postinsertion. The study suggests that the TCu 380A, LLD and MLCu 375 IUDs seem to be safe and effective contraceptive options for Indonesian women.

Adolescent↗
PubMed2005

Five years' experience with a small intracervical/intrauterine levonorgestrel-releasing device.

OBJECTIVE: A randomized study was performed to compare the efficacy, safety and acceptability of a new model of an intracervical/intrauterine contraceptive device (ICD) releasing 20 microg of levonorgestrel (LNG) per day. METHODS: The LNG-ICD was inserted in Group I into the cervical canal and in Group II into the uterine cavity. Group I included 151 women (age, 18-43 years) whereas Group II included 147 (age, 19-43 years). The number of nulliparous women was 145. RESULTS: The 5-year results are presented here. The results showed a total continuation rate of 50%; the continuation rate in the cervical group and that in the uterine group were 53.6% and 46.3%, respectively--the difference being statistically insignificant (p=.3593). The main reason for termination was a wish for pregnancy, which is explained by the relatively young age and degree of nulliparity of the study population. During the first year, two pregnancies occurred in both groups. Two of these were ectopic, one in each group. The other two occurred after unnoticed expulsions. Thereafter, no pregnancies occurred. The cumulative gross rate for pregnancy was 1.3 and the Pearl index at 5 years was 0.425. The total expulsion rate was relatively high (11.1%). Expulsions occurring during the first few months of the first year were related to insertion. Removals because of bleeding and because of amenorrhea were low, the combined gross rate being 5.7 and the Pearl rate 1.8 at 5 years. Also, the gross rate of infection was low (0.7). The continuation was high in spite of a high rate of removals for planning pregnancy (15.4). CONCLUSIONS: The method is safe and effective. There were only minor differences between the groups. There were no perforations and the incidence of infection was low. The device can also be used by young nulliparous women.

Adolescent↗
PubMed1994

The pathology of intra-uterine contraceptive devices.

The IUCD is a simple and effective way of producing contraception without the need for patient compliance. It is not rendered ineffective by other drugs, as may be steroid contraceptives, and its side-effects, for carefully selected patients, are considered by most practitioners to be acceptably low (Van Kets et al. 1989).

Cervix Uteri↗
PubMed2005

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.

Adult↗
PubMed2001

Introduction of the GyneFix intra-uterine device into the UK: client satisfaction survey and casenotes review.

OBJECTIVE: To assess the first year's use with the GyneFix intra-uterine device. This has been used in Liverpool since early 1997. It is offered mainly to nulliparous women wishing to use an effective non-hormonal method and parous women who have had pain with, or expulsion of, a framed device previously. It is also used as emergency contraception. DESIGN: Retrospective study, by means of casenote review and client questionnaire. PARTICIPANTS: All GyneFix users from February 1997 to January 1998; 215 women in total. MAIN OUTCOME MEASURES: Data were extracted from casenotes to determine reasons for choice of GyneFix, parity, whether the insertion was planned or as an emergency measure, problems reported at follow-up and reasons for removal. Users were asked by questionnaire to comment on insertion procedure, menstrual or other changes since insertion and to state their overall satisfaction. RESULTS: Over half of the users (57%) were nulliparous and a quarter of insertions were for emergency contraceptive use. A third reported that insertion was 'very painful'. Half reported that their periods had become heavier since insertion, but only 8% said that they were now unmanageable. Unacceptable bleeding was the most common reason for removal. Some reported intermenstrual bleeding and dysmenorrhoea. Satisfaction with the GyneFix was high; 86% of questionnaire responders said that they would recommend it to a friend. CONCLUSION: The GyneFix is well accepted in Liverpool inappropriately selected clients, and is an effective non-hormonal method for nulliparous as well as parous women.

Contraception↗
PubMed1976

Contraceptive efficacy of two different metals using a modified seven vector.

Early studies with copper suggested that few improvements in overall IUD performance could be obtained with the use of more than 200 mm2 of copper. Thus, the use of other metals paired with copper has been investigated. This report of two studies of the small Copper-7, one with zinc and the other with copper alone, suggests that the addition of zinc in the superior position of the small Cu-7 decreases the incidence of pregnancy and that the small Cu-7 may be associated with higher retention rates than the standard Cu-7.

Adult↗
PubMed1976

Evaluation of trained midwives in a copper-T IUD insertion Program in Isfahan, Iran.

From four centers in Isfahan, data from 252 insertions of the Cu-T-200 made by midwives and 646 insertions of the same device made by doctors are compared. Although the net cumulative one-year continuation rate for women who had a copper-T inserted by a midwife is significantly lower than for women who had a copper-T inserted by a doctor there are no significant differences between the one-year event rates for the two groups of patients. These data suggest that an expanded role for midwives in IUD insertion programs would be an efficient use of health personnel.

Copper↗