Gaston Farr

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.

Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each of six developing countries. The pregnancy rate with the TCu 380A IUD was significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a disproportionately higher incidence of side effects such as intermenstrual bleeding or pain, inflammations or infections, or insertion-related events compared to the TCu 200 IUD. TCu 380A IUD users, however, were significantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregnancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-term, reversible birth control without having to resort to hormonal methods.

Interactions between intrauterine contraceptive device use and breast-feeding status at time of intrauterine contraceptive device insertion: Analysis of TCu-380A acceptors in developing countries

OBJECTIVE This paper is a reassessment of earlier findings from a preliminary analysis of data from a multicenter international trial regimen on breast-feeding and non-breast-feeding women in which events related to insertion, expulsion, and removal of the TCu-380A intrauterine contraceptive device (ParaGard 380) were investigated. STUDY DESIGN Performance of the TCu-380A through 12 months after insertion was compared with life-table rate analysis, chi 2, Fisher exact test, or Students t test. Variables were events reported during intrauterine contraceptive device insertion and events throughout the 12 months of study participation by breast-feeding status. RESULTS Breast-feeding among intrauterine contraceptive device users was associated with fewer insertion-related complaints and lower removal rates for bleeding and pain. No uterine perforations were reported throughout the study. CONCLUSION Differences in the performance of the TCu-380A intrauterine contraceptive device suggest physiologic effects associated with lactational amenorrhea. The TCu-380A intrauterine contraceptive device is a viable option for women breast-feeding at the time of intrauterine contraceptive device insertion.

Effectiveness of the non-spermicidal fit-free diaphragm

Standard instructions for diaphragm use call for an individually sized latex diaphragm, used in conjunction with spermicide jelly. However, some investigators have reported that the diaphragm can be effective without a spermicide. A non-randomized trial designed to measure the contraceptive effectiveness of the diaphragm used without spermicide was conducted. A total of 110 self-selected women were enrolled to use a non-spermicide fit-free (60mm) diaphragm for a period of one year. They were advised to wear the diaphragm continuously, removing it once each day for washing but not within six hours after intercourse. Product-related problems related to insertion, retention and removal were few at both the 6- and 12-month follow-up visits, most commonly odor. The 12-month life table accidental pregnancy rate during typical use was 24.1 per 100 women (29.5 per 100 women without female barrier experience and 17.9 per 100 women with barrier experience). Over 85% of the women who returned for follow-up visits reported using the diaphragm during every act of intercourse. Until better data refute the traditional recommendations, users should be advised to add spermicide to fitted latex diaphragms.

Clinical performance of the TCu 380A and TCu 220C IUDs in four developing country family planning clinics.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.

Do retroverted uteri adversely affect insertions and performance of IUDS

A large international multi-center IUD data set (N = 5520) coordinated by Family Health International was analysed to determine if the uterine position of a woman (anteverted, mid-positioned or retroverted) affects the ease of IUD insertion and if knowledge of uterine position would diminish insertion-related problems and improve IUD performance. Findings showed that insertion-related events were rare irrespective of uterine position. Women with retroverted uteri were not associated with higher termination rates for accidental pregnancy, expulsion or removal for bleeding and/or pain after 12 months of IUD use, as compared to the other two uterine position groups. All insertions in this data set were performed by experienced obstetricians/gynecologists, and our findings suggest that women with retroverted uteri should be equally good candidates for IUD contraception.

Twelve-month comparative multicenter study of the TCu 380A and ML 250 intrauterine devices in Bangkok, Thailand

The long-term effectiveness of the copper-bearing intrauterine device (IUD) has been documented. This paper reports 12-month results from a multiyear comparative study of the Copper T (TCu) 380A and Multiload (ML) 250 IUD in Bangkok, Thailand, among 1396 women. Continuation of the assigned IUD was relatively high after 12 months of use, with continuation rates of 90.17 and 87.54 per 100 women, respectively. Whereas the accidental pregnancy rate was higher for the ML 250 IUD than for the TCu 380A IUD (1.0 and 0.2 per 100 women, respectively), this difference was not considered statistically significant (p < 0.69). The rate of IUD expulsion was significantly higher among women using the ML 250 IUD than for women using the TCu 380A IUD (4.61 and 2.40 per 100 women, respectively, p = 0.05).

Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigators choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).

Clinical evaluation of the TCu 380A IUD at six Latin American centers

Compared with other contraceptive methods such as sterilization and oral contraceptives, the prevalence of IUD use in Latin American countries is relatively low. This study evaluated the clinical performance of the TCu 380A IUD in six Latin American clinics to determine whether its performance was a determining factor in its low prevalence, and to provide efficacy and safety data based on local data sets to Latin American service providers. The 12-month unintended pregnancy rate ranged from 0.0 to 1.7 per 100 women and the 12-month discontinuation rates for all reasons, from 3.3 to 21.0 per 100 women. Statistically significant differences in discontinuation rates were observed among clinics, and could be explained, in part, by the different sociodemographic and clinical characteristics of women attending the clinics. The overall performance and acceptability of the TCu 380A IUD was considered satisfactory and comparable to those reported from other countries. Thus, the low prevalence of IUD use in Latin America is probably related to barriers to its use rather than its clinical performance.

An evaluation of the Copper-T 380A IUD's safety and efficacy at three African centers

The use of intrauterine devices in Africa is low compared with other contraceptive methods such as oral contraceptives. This study, coordinated by Family Health International, evaluated the clinical performance (safety and efficacy) of the TCu 380A IUD in three African centers, respectively, in Cameroon, Egypt, and Nigeria from 1986-1989. The 12-month unintended pregnancy rates were low for all three centers, ranging from none to 1.6 per 100 women. The 12-month discontinuation rates for all reasons ranged from 8.8 to 26.9 per 100 women. Statistically significant differences were observed among clinics for discontinuation rates for bleeding and/or pain and for planned pregnancy. The overall performance of the TCu 380A IUDs was considered satisfactory. Thus, the limited use of IUD in Africa could be due to the lack of accessibility, lack of information about, and confidence in the method rather than to documented clinical performance.