Microdose intrauterine levonorgestrel for contraception. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on Intrauterine Devices for Fertility Regulation. Contraceptive efficacy of the Copper T380A and the Multiload Cu250 IUD in three developing countries. Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries. Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: feasibility of enrollment, continuation and disease ascertainment. Performances of copper T 380A and multiload copper 375/250 intrauterine contraceptive devices in a comparative clinical trial. Community-based distribution and contraception usage in Iran. A comparative clinical trial of Copper T 220 C and Alza T IPCS 52 intrauterine devices in Thai women. Impact of antenatal counselling on couples' knowledge and practice of contraception in Mansoura, Egypt. Intrauterine contraception for adolescents aged 14-18 years: a multicenter randomized pilot study of levonorgestrel-releasing intrauterine system compared to the Copper T 380A.
An intrauterine device (IUD) releasing 2 micrograms of levonorgestrel per 24 hours was compared in a randomized multicentre clinical trial with two copper IUDs-the TCu 220C and the Nova T. The 2 micrograms levonorgestrel device had statistically significantly higher pregnancy rates (from 390 days of use) and higher expulsion rates (up to 570 days). In addition, the total medical removals and removals for bleeding were significantly higher at all intervals where the data were analysed. Most disturbing was a 6.7 increased relative risk of ectopic pregnancy with the steroid-releasing IUD compared to the combined copper IUD data. It is concluded that the goal of microdose administration of 2 micrograms levonorgestrel to the uterine cavity does not achieve the objectives of a new and improved IUD device which is safe and effective. The clinical performance of the Copper T380A (TCu380A) and the Multiload 250 (MLCu250) 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 three developing countries. The gross cumulative life-table pregnancy rate of the TCu380A IUD was significantly lower than the rate with the MLCu250 IUD at 12 months (0.5 and 1.2, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. TCu380A IUD users were more likely to report experiencing increased dysmenorrhea (p < 0.01) or intermenstrual pelvic pain (p < 0.01) than were MLCu250 IUD users. However, few of these users discontinued use of their assigned IUD because of having experienced menstrual bleeding disturbances or intermenstrual pelvic pain. These data indicate that the TCu380A IUD may be a better option than the MLCu250 IUD for women wishing to practice highly effective long-term birth control without having to resort to hormonal methods. 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. We conducted a feasibility study to enroll and follow family planning acceptors who were randomly assigned to use an intrauterine device (IUD) or injectable depot-medroxyprogesterone acetate (DMPA).
                Centers in Brazil, Guatemala, Egypt and Vietnam aimed to enroll 100 participants per site. Enrolled women were randomly assigned to have inserted a TCu 380A IUD, or to receive injections of 150 mg of DMPA every 3 months, and scheduled for up to 12 months of follow-up. We tested for cervical infection at first and final visits, and examined for signs of pelvic inflammatory disease (PID) at each visit.
                The sites screened 555 women and enrolled 368. Two women (0.5%) had three discomfort signs of PID during follow-up. The prevalence of gonorrhea at each woman's final follow-up visit was 0.5%, and the prevalence of chlamydia at final visit was 5.4%. Sixty-eight percent of women either completed 12 months of observation with their assigned method or were still using their method at the end of the study.
                A larger, definitive clinical trial appears feasible. The majority of women we approached agreed to participate; nearly 400 women were enrolled; two thirds continued to use their assigned method until study closeout; and the STI risk was moderate. An evaluation of the performances of copper T 380A (TCU 380A) and multiload copper 375/250 (MLCU 375/250) intrauterine contraceptive devices (IUCDS) was carried out at University College Hospital, Ibadan, Nigeria (UCH) in a clinical comparative trial. The IUCDS showed similar low vent rates at one year of continuous use. The difference in cumulative net probabilities for termination due to pelvic inflammatory disease was weakly significant at the sixth month of follow up with MLCU 250 having the highest rate. (TCU 380A-0%; MLCU 375-0%; MLCU 250-3.1%; X2 = 6.0; P < 0.05). This significant difference disappeared by the twelfth month of continuous use. Likewise, the difference in cumulative net probabilities for overall termination was significant at six months and insignificant at twelve months of follow up. The continuation rate after one year were 86%, 92% and 87% respectively for TCU 380A, MLCU 375 and MLCU 250. These rates were higher than 80% and 51% quoted for the previously available Lippes loop in the same environment [1,2]. It was therefore concluded that the three IUCDS are comparable in performances in the first year of use and could be used at our family planning clinic or any other clinic in a similar setting. Despite the availability of free contraception from family planning clinics, the rate of unwanted pregnancy in Iran is still high. The effectiveness of other methods for contraceptive supply should, therefore, be evaluated. The aim of this study was to determine the effects of community-based distribution (CBD) on contraceptive usage in Iran.
                This controlled field trial study involved 297 individuals (100 subjects in the CBD group and 197 subjects in the control group) from four major remote areas of Hamedan, Iran. Stratified random sampling was used.
                Data analysis suggested that using CBD has four major effects: (1) it increases the level of contraceptive knowledge (p<0.0001), (2) it enhances correct contraceptive choice by couples (p<0.0001), (3) it improves contraceptive usage (p<0.0001) and (4) it improves contraceptive continuation rates (p<0.0001).
                CBD facilitates better knowledge, proper choice, and correct and continuous usage of contraception. This method should, therefore, be adopted for family planning services in remote areas of Iran. Two IUDs (Copper T 220 C and Alza T IPCS 52) were comparatively studied by randomized insertions in 200 Thai women who attended the Family Planning Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University. Point estimates of the pregnancy rate and rate of removal for bleeding and pain at 18 months were lower for the copper device than for the Alza T IPCS 52, but neither these nor any other pertinent event rates reached statistical significance. Study of the Alza device was halted before the completion of 2 years because reports from other centres indicated an unacceptable pregnancy rate beyond 2 years. The impact of antenatal counselling on couples' knowledge and practice of contraception was investigated. An interview questionnaire was used before and after conducting counselling sessions with 200 pregnant women and 100 spouses. The participants were followed up immediately after delivery and 3 months later. Both the control and study groups displayed a lack of knowledge of contraception. Counselling sessions improved the couples' knowledge and practice in the study group. Involving husbands in family planning counselling sessions led to joint decisions being made and encouraged women's use of contraception. The majority of couples retained most of the information given. Integrating family planning counselling into antenatal care in all facilities and involving the husband are recommended. Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data.
                Multicenter, randomized, controlled, participant-blinded pilot study of 14-18-year-old females assigned to the Copper T 380A intrauterine device or the Levonorgestrel Intrauterine System. Participants were followed up for 6 months following insertion.
                We enrolled 23 participants; 12 received the Levonorgestrel Intrauterine System, and 11 received the Copper T 380A. At 6 months, the continuation rates were 75% for the Levonorgestrel Intrauterine System users and 45% for the Copper T 380A users (p=.15). Two Copper T 380A users experienced partial expulsion. Heavy bleeding and pelvic pain were the most commonly reported side effects. Participants rated both methods favorably.
                This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.
Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.