Community health worker promotions increase uptake of long-acting reversible contraception in Rwanda.

BACKGROUND: We coordinated community health worker (CHW) promotions with training and support of government clinic nurses to increase uptake of long-acting reversible contraception (LARC), specifically the copper intrauterine device (IUD) and the hormonal implant, in Kigali, Rwanda. METHODS: From August 2015 to September 2016, CHW provided fertility goal-based family planning counseling focused on LARC methods, engaged couples in family planning counseling, and provided written referrals to clients expressing interest in LARC methods. Simultaneously, we provided didactic and practical training to clinic nurses on LARC insertion and removal. We evaluated: 1) aggregate pre- versus post-implementation LARC uptake as a function of CHW promotions, and 2) demographic factors associated with LARC uptake among women responding to CHW referrals. RESULTS: 7712 referrals were delivered by 184 CHW affiliated with eight government clinics resulting in 6072 family planning clinic visits (79% referral uptake). 95% of clinic visits resulted in LARC uptake (16% copper IUD, 79% hormonal implant). The monthly average for IUD insertions doubled from 29 prior to service implementation to 61 after (p < 0.0001), and the monthly average for implant insertions increased from 109 to 309 (p < 0.0001). In adjusted analyses, LARC uptake was associated (p < 0.05) with the CHW referral being issued to the couple (versus the woman alone, adjusted odds ratio, aOR = 2.6), having more children (aOR = 1.3), desiring more children (aOR = 0.8), and having a religious affiliation (aOR = 2.9 Protestant, aOR = 3.1 Catholic, aOR = 2.5 Muslim each versus none/other). Implant versus non-LARC uptake was associated with having little or no education; meanwhile, having higher education was associated with IUD versus implant uptake. CONCLUSIONS: Fertility goal-based and couple-focused family planning counseling delivered by CHW, coupled with LARC training and support of nursing staff, substantially increased uptake of LARC methods.

Emergency contraception: Oral and intrauterine options.

BACKGROUND: Emergency contraception can be used to prevent pregnancy where contraception has not been used, or there has been contraceptive misuse or failure. Australian women have three options for emergency contraception: two types of oral pills (levonorgestrel [LNG]-containing pill and ulipristal acetate [UPA]) and the copper intrauterine device (IUD). Both pills are available from pharmacies without prescription, whereas the copper IUD requires insertion by a trained provider. OBJECTIVE: The objective of this article is to describe the indications, efficacy and contraindications for use of the three emergency contraceptive methods available in Australia. DISCUSSION: Emergency contraception can potentially reduce the risk of unplanned pregnancies. The oral methods have similar side effects, but UPA is more effective than LNG and can be used up to five days after intercourse. The copper IUD is the most effective method, and provides ongoing contraception for up to 10 years. Factors to consider when recommending one option over another include time since unprotected sex, body mass index and use of enzyme-inducing medicines.

Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.

Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm3. Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial (n = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a "continuous use" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm3 and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log10 copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm3 (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm3 slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.

Feasibility and Safety of IUD Insertion by Mid-Level Providers in Sub-Saharan Africa.

CONTEXT: The copper IUD is safe and effective, but underutilized in Sub-Saharan Africa, in part because of a lack of trained providers. The World Health Organization recommends training mid-level providers-including nurses and midwives-to insert IUDs; however, the safety of such task shifting has not been evaluated in Sub-Saharan Africa. METHODS: Data were drawn from baseline surveys and study charts of 535 sexually active women aged 18-45 who used a copper IUD while participating in an HIV-prevention clinical trial conducted from August 2012 through June 2015 in Malawi, South Africa, Uganda and Zimbabwe. IUDs were inserted by study physicians, nurses and midwives trained as part of the trial, and by local nonstudy providers. Chi-square and Fisher's exact tests were used to compare women's experiences of adverse events-such as irregular bleeding, pelvic pain or device expulsion-by provider type. RESULTS: Half (54%) of women reported experiencing an adverse event; the most common were irregular bleeding and pelvic pain (45% and 25%, respectively). Compared with women who had received an IUD from a study physician or study nurse, greater proportions of women who had received one from a nonstudy provider reported any adverse event (76% vs. 49% and 51%, respectively), irregular bleeding (57% vs. 41% and 45%) and pelvic pain (35% vs. 15% and 32%); the difference between study physicians and nurses was significant only for pelvic pain. Expulsion rates were comparable for study nurses and nonstudy providers (12.3 and 11.9 per 100 woman-years, respectively), but lower for study physicians (7.3 per 100 woman-years). CONCLUSIONS: The findings support task shifting of IUD insertion to mid-level providers to improve IUD access in Sub-Saharan Africa.

RESUMEN Contexto: Aunque el DIU de cobre es seguro y efectivo, está subutilizado en África subsahariana, en parte debido a la falta de proveedores de servicios de salud capacitados. La Organización Mundial de la Salud recomienda capacitar a los proveedores de nivel medio ­incluidas las enfermeras y parteras­ para insertar los DIU; sin embargo, la seguridad de tal cambio de tareas ha sido evaluada en África subsahariana. Métodos: Se obtuvieron datos de encuestas de línea de base y cuadros de un estudio de 535 mujeres sexualmente activas, de 18 a 45 años, que usaron un DIU de cobre en un ensayo clínico de prevención del VIH realizado entre agosto de 2012 y junio de 2015 en Malaui, Sudáfrica, Uganda y Zimbabue. Los DIU fueron insertados por médicos participantes en el estudio, enfermeras y parteras capacitadas como parte del ensayo, así como por proveedores de servicios de salud locales no relacionados con el estudio. Las pruebas exactas de Chi-cuadrado y Fisher se usaron para comparar las experiencias de las mujeres con eventos adversos ­como sangrado irregular, dolor pélvico o expulsión del dispositivo­ por tipo de proveedor. Resultados: La mitad (54%) de las mujeres reportaron haber experimentado algún evento adverso; los eventos más comunes fueron sangrado irregular y dolor pélvico (45% y 25%, respectivamente). En comparación con las mujeres que habían recibido un DIU de un médico o de una enfermera del estudio, una gran parte de las mujeres que lo habían recibido de un proveedor no relacionado con el estudio reportaron algún tipo de evento adverso (76% vs. 49% y 51%, respectivamente), sangrado irregular (57 % vs. 41% y 45%) y dolor pélvico (35% vs. 15% y 32%); La diferencia entre los médicos y las enfermeras del estudio fue significativa solo para el dolor pélvico. Las tasas de expulsión fueron comparables para las enfermeras del estudio y los proveedores no relacionados con el estudio (12.3 y 11.9 por 100 años-mujer, respectivamente), pero más bajas para los médicos del estudio (7.3 por 100 años-mujer). Conclusiones: Los hallazgos respaldan el cambio de tareas de inserción del DIU a proveedores de nivel medio para mejorar el acceso al DIU en África Subsahariana.

RÉSUMÉ Contexte: Bien qu'il soit sûr et efficace, le DIU au cuivre est sous-utilisé en Afrique subsaharienne, faute, en partie, de prestataires formés. L'Organisation mondiale de la Santé recommande la formation de prestataires de niveau intermédiaire ­ personnel infirmier et sages-femmes ­ pour la pose du DIU. La sécurité de cette délégation de tâches n'a cependant pas été évaluée en Afrique subsaharienne. Méthodes: Les données proviennent d'enquêtes de base et de graphiques d'étude concernant 535 femmes sexuellement actives âgées de 18 à 45 ans qui utilisaient un DIU au cuivre dans le cadre d'un essai clinique de prévention du VIH réalisé d'août 2012 à juin 2015 en Afrique du Sud, au Malawi, en Ouganda et au Zimbabwe. Les DIU avaient été posés par les médecins, infirmières et sages-femmes de l'étude, formés dans le cadre de l'essai, ainsi que par des prestataires locaux extérieurs à l'étude. Le test chi carré et la méthode exacte de Fisher ont servi à comparer l'expérience d'effets indésirables ­ tels que saignements irréguliers, douleurs pelviennes ou expulsion du DIU ­ vécus par les femmes suivant le type de prestataire. Résultats: La moitié (54%) des femmes ont signalé un effet indésirable, les plus courants étant les saignements irréguliers et les douleurs pelviennes (45% et 25%, respectivement). Par rapport aux femmes dont le DIU avait été posé par un médecin ou une infirmière de l'étude, de plus grandes proportions de celles qui avaient obtenu leur dispositif d'un prestataire extérieur à l'étude ont signalé un effet indésirable quelconque (76% contre 49% et 51%, respectivement), des saignements irréguliers (57% contre 41% et 45%) et des douleurs pelviennes (35% contre 15% et 32%). La différence entre les médecins et le personnel infirmier de l'étude n'est significative que pour les douleurs pelviennes. Les taux d'expulsion sont comparables pour les infirmières de l'étude et les prestataires extérieurs (12,3 et 11,9 pour 100 femmes-années, respectivement), mais il est moindre pour les médecins de l'étude (7,3 pour 100 femmes-années). Conclusions: Les résultats sont favorables à la délégation de la pose du DIU aux prestataires de niveau intermédiaire pour améliorer l'accès au DIU en Afrique subsaharienne.

What Nurses Need to Know About Immediate Postpartum Initiation of Long-Acting Reversible Contraception.

Initiation of long-acting reversible contraception (LARC) in the immediate postpartum period is becoming more common, resulting in increased requests for early removal, primarily because of unpredictable bleeding patterns. Competing interests of healthful spacing of pregnancies, impact on breastfeeding, risks associated with pregnancy versus contraceptive method, potential adverse effects of LARC, and timing of informed consent make immediate postpartum initiation of LARC an important issue. Nearly 40% of women do not attend a postpartum visit at all, resulting in decreased initiation of contraception and increased risk of unplanned pregnancy. Nurses caring for women during the peripartum period can help women make informed decisions and can provide anticipatory guidance regarding this method of contraception. Evidence-based postpartum education and support can result in women's increased continuation of and satisfaction with LARC.

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.

Acceptability and clinical performance of a copper-containing frameless IUCD in Hong Kong.

This is the first study conducted in Hong Kong to evaluate the acceptability and clinical performance of a copper-containing frameless intrauterine contraceptive device (IUCD; GyneFix/Ji Ni). Sixty-two women chose to use the frameless IUCD for contraception. A learning curve was demonstrated in the insertion technique of this new device. Pain associated with insertion was acceptable. No pregnancy was reported during the 1-year trial period. Objectively, the amount of menstrual loss did not change and dysmenorrhea improved, but the duration of menstrual flow was slightly prolonged during the use of this device. However, there was a 10.7% request rate for removal of the device because of its side effects. The expulsion rate during the first year was 5.3%, and the continuation rate at the end of the first year was 76.7%. It was found that 85% of the 40 subjects interviewed upon the completion of the 1-year trial period wished to replace the same device after the product expiration date and that 92.5% would recommend this device to their friends. In summary, the clinical performance of the frameless IUCD was comparable to its framed counterparts. The device was considered acceptable to a majority of the women.

The Nova-T IUD--a review of the literature.

The Nova-T IUD is being widely used in Western Europe, Canada, and some parts of Asia; numerous studies based on comparative trials with other types of IUDs have been reported. The results were consistent among most studies, but conflicting among others. This review paper revealed that, in general, the Nova-T IUD is a safe, effective, and acceptable device for contraception. However, more comparative studies with the other copper-releasing IUDs are needed to resolve some of the controversial findings on its long-term (e.g., five years or more) efficacy, especially with the TCu 380A which has the prospect of being used worldwide. The epidemiological (e.g., effects of age, parity, and lactating status of the women) and programmatic aspects (e.g., provider factors and timing of insertion) related to the performance of this device are also reviewed in this paper.

Copper loss from the copper T model TCu22OC.

The effect of mineral deposits on the copper dissolution rate of the Copper T Model TCu22OC was examined. 118 Copper T22OC devices removed from subjects for various medical and personal reasons after 12 to 72 months in utero were examined and graded based on the proportion of the total copper area covered with mineral deposits. The deposits increased in average size during the first three years of IUD use and then remained relatively constant. Seventeen percent of the devices were in situ for four or more years. Copper analysis was performed on 30 Copper T 22OC devices from selected periods of use : 12-14, 22-26, 36-39 and 48-72 months of use. The mean daily copper loss was 29.4 micrograms and the range, 7.3 to 62.1 micrograms. An inverse correlation between the amount of mineral deposit on the copper surface and the rate of copper loss was observed.

The TCu 380A IUD and the frameless IUD "the FlexiGard": interim three-year data from an international multicenter trial. UNDP, UNFPA, and WHO Special Programme of Research, Development and Research Training in Human Reproduction, World Bank: IUD Research Group.

The TCu 380A and FlexiGard IUDs were compared in a randomized multicenter trial including 28 institutes in 13 countries. There were 53 insertion failures with the FlexiGard and one with the TCu 380A. There were 2184 successful insertions of the TCu380A and 2102 of the FlexiGard device. The three-year pregnancy rates for the TCu 380A and FlexiGard were similar (1.6 and 1.9 per 100 women, respectively) but the FlexiGard three-year expulsion rate (7.4 per 100 women) was significantly higher than that of the TCu 380A (4.4 per 100 women). The insertion technique for the FlexiGard needs to be improved in order to lower the expulsion rate.

A three-year evaluation of TCu 380 Ag and multiload Cu 375 intrauterine devices.

A randomized, comparative, multicenter clinical trial of TCu 380Ag and Multiload Cu 375 intrauterine devices (IUDs) was conducted. Safety and acceptability were evaluated through three years following insertion in 884 patients. The two IUDs were similar with respect to all event rates. Thirty-six month life table pregnancy rates were 0.6 per 100 TCu 380Ag users and 1.8 per 100 Multiload Cu 375 users. Continuation rates were 67.4 and 61.4 per 100 users of the respective devices at three years after insertion.

Clinical outcomes of two early postpartum IUD insertion programs in Africa.

Postpartum IUD insertion programs are new to Africa and few have been carefully evaluated. Also, data on the clinical outcomes of postpartum IUD insertions using the Copper T 380A IUD are sparse. Therefore, we conducted a study to evaluate introductory postpartum IUD programs using the Copper T 380A IUD in Kenya and Mali. Postpartum IUD acceptors in Kenya (n = 224) and Mali (n = 110) were interviewed at baseline and at 1, 3, amd 6 months after delivery. We compared expulsion, medical removal, and discontinuation rates by insertion characteristics in each country. Six-month cumulative expulsion rates were lower for immediate insertions (those within 10 minutes of placental delivery) than for late insertions (generally between 10 minutes and 72 hours after placental delivery) in both Kenya (0.01 vs 0.05) and Mali (0.15 vs 0.27). Medical removals occurred in 1% and 7% of Kenyan and Malian acceptors, respectively, while pelvic infections were rare in both countries (< or = 2%). Differences in 6-month cumulative discontinuation rates between immediate and late insertions were not significant in either Kenya (0.05 vs 0.07) or in Mali (0.24 vs 0.32). This study suggests that postpartum IUD insertions can be performed safely with acceptable expulsion rates in African settings. Previous studies of other IUDs showed that expulsion rates are lower for immediate insertions compared with late postpartum insertions. This study suggests that these findings can be extended to the Copper T 380A IUD.

An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs.

The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs. This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.

PIP: This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.

Long-term reversible contraception. Twelve years of experience with the TCu380A and TCu220C.

Few data on the long-term efficacy of intrauterine devices (IUD) are available, and this article reports on the final 12-year experience with the TCu220C and TCu380A devices from two randomized, multicenter trials conducted in 24 centers. A total of 3,277 and 1,396 women, respectively, were recruited for use of each device between 1981 and 1986 and followed at 3, 6, and 12 months after insertion and yearly thereafter. At the end of 12 years, a total of 17,098 women-years of experience had been accumulated for the TCu220C and 7,159 women-years for the TCu380A. The cumulative 12-year intrauterine pregnancy rates were 7.0 (standard error [SE] 0.6) per 100 women for the TCu220C and 1.9 (SE 0.5) for the TCu380A (p < 0.001). Pregnancy rates were highest in the first years after insertion; the TCu220C had a consistently higher annual pregnancy rate than did the TCu380A at all intervals since insertion. No pregnancies were reported with the TCu380A after 8 years of use. Total medical removals were approximately 6% in the first year and dropped to approximately 4% per year for each device for up to 12 years of use (cumulative 12 year rates were 37.3 [SE 1.3] and 40.2 [SE 2.1] per 100 women for the TCu220C and TCu380A devices, respectively). The overall continuation rate at all intervals since insertion was higher with the TCu220C device, mainly due to higher removal rates for nonmedical reasons with the TCu380A. The cumulative ectopic pregnancy rates were 0.7 and 0.4 for the TCu220C and TCu380A, respectively. Pregnancy rates were higher in the Chinese compared with the non-Chinese centers for both devices, though the greater efficacy of the TCu380A was apparent in both groups of centers. The total medical and nonmedical removal rates were lower in the Chinese compared with the non-Chinese centers, and did not show any substantial differences between the devices. We conclude that both devices are safe and effective for at least 12 years of use and the low pregnancy rate with the TCu380A is comparable with that reported in the United States among women who had undergone tubal sterilization. The very high efficacy of the TCu380A makes it the IUD of choice, and it can be considered as a potentially reversible, non-surgical alternative to sterilization for women requiring very long-term pregnancy protection.

Intrauterine contraception in nulligravid vs parous women.

The performance of MLCu-250 IUDs inserted in 525 nulligravid women was studied for four years and is compared to the results obtained in the same period from 2770 parous women using TCu-200, 7Cu-200 and Nova-T IUDs. In every case the choice of the particular IUD model took into account hysterometry and diameter of the inner cervical orifice in order to aim at the highest theoretical efficacy. The MLCu-250 in nulligravid women produced failure and expulsion rates below those of the other models in parous users; no difference was observed in the case of removal because of bleeding or pain. Finally, there was no case of subsequent infertility or pelvic inflammatory disease (PID) recorded among nulliparae. These results suggest that an adequate choice of the IUD model for nulliparous women with low risk of PID gives as reliable results as in multiparous women.

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.

Corrosion behavior of copper in a copper bearing intrauterine device in the presence of indomethacin.

As an improvement to the use of the copper bearing intrauterine device, indomethacin has been introduced to reduce the incidence of bleeding after insertion of the device. The effects of indomethacin on copper corrosion were studied in vitro in simulated uterine fluid. Electrochemical polarization resistance measurements indicated that indomethacin powder slightly increased the corrosion rate of copper if pH of the fluid was not under control and it did not change the corrosion rate if pH was adjusted daily to maintain some constancy. The experimental results for medication by indomethacin-releasing Silastic were basically the same as those with powdered indomethacin. X-ray diffraction showed that only cuprous oxide was formed on the copper substrated surface and that indomethacin did not affect the corrosion products. As scanning electron microscopy demonstrated, however, in the presence of indomethacin the oxide particles formed were found to be more coarse and dense than in the absence of indomethacin.

PIP: The effects of indomethacin--a prostaglandin synthesis inhibitor introduced to copper-bearing IUDs to reduce the incidence of postinsertion bleeding--on copper corrosion were investigated in vitro in simulated uterine fluid by Chinese researchers. Indomethacin was introduced to the solution either in various amounts of powdered preparation or in indomethacin-releasing Silastic of different contents. Electrochemical polarization resistance measurements indicated that indomethacin powder slightly increased the copper corrosion rate if the pH of the fluid was not under control, but did not affect corrosion when the pH was adjusted daily to maintain some constancy. Indomethacin-releasing Silastic produced similar effects. X-ray diffraction revealed that, after immersion in the simulated uterine fluid for 7 days, only cuprous oxide was formed on the copper substrate surface, regardless of the presence of indomethacin. Scanning electron microscopy showed that the oxide particles formed were more course and dense in the presence of indomethacin, however. Although these findings suggest that indomethacin does not affect the general corrosion rate of copper, further research is required to verify reduced ion generation.

The effect of adding copper onto Lippes Loop IUDs: results from a ten-year study in Yugoslavia.

The present study is the first randomized ten-year comparison of the standard, non-medicated Lippes Loop D and the same device with the addition of 200 mm2 of copper in the form of copper sleeves. The devices were randomly inserted immediately after first trimester medical termination of pregnancy. Out of 400 postabortal IUD insertions, 371 were followed for up to ten years. Gross cumulative life-table accidental pregnancy rates after one year of use were 0.56 for the copper-bearing Lippes Loop and 4.63 for the standard Lippes Loop. After two, four and ten years, these rates were 1.24, 2.70 and 3.62 and 6.03, 7.58 and 14.94, respectively (in all comparisons, rates were significantly different at the 0.05 level or lower). At each time interval, expulsion/displacement rates were 4.49, 4.49, 5.23 and 6.32 for the copper-bearing Lippes Loop and 12.61, 13.29, 15.46 and 19.79 for the standard Lippes Loop (rates were significantly different at the 0.01 level or lower). Differences in removal rates for bleeding and/or pain were not significantly different at any of the follow-up intervals. The lower event rates for copper-bearing Lippes Loop D users indicates that the addition of copper to the Lippes Loop IUD may result in better long-term efficacy profiles for this device among postabortal women. The results also suggest that large, medicated IUDs may be more efficacious for women with larger uteri who often experience higher failure rates due to expulsion or displacement of smaller IUDs into the lower uterine segment.

Consensus statement on emergency contraception.

Twenty-four experts from around the world, representing the fields of research, policy, communications, women's advocacy and medicine, gathered at the Rockefeller Foundation Conference Center in Bellagio, Italy, in April 1995 to discuss emergency contraception. The conference was hosted by South-to-South Cooperation in Reproductive Health and co-sponsored by the International Planned Parenthood Federation, Family Health International, the Population Council and the World Health Organization. The conference was supported by the Rockefeller Foundation.

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 investigator's 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%).

PIP: A randomized clinical trial conducted at collaborating research sites in Peru, Nigeria, and Turkey found no significant differences between the performance of the Copper T 380A (TCu 380A) IUD and the Lippes Loop at 12 months post-insertion. The Lippes Loop is one of the few unmedicated IUDs still in use in developing countries, while the TCu 380A is steadily gaining in favor because of its longer effective life-span. Included in the analysis were 356 TCu 380A acceptors and 354 Lippes Loop users. The accidental pregnancy rate was 0.7/100 women-months of exposure for the TCu 380A and 2.1/100 for the Lippes Loop (p = 0.25); the expulsion rates were 3.5% and 6.7%, respectively, and the discontinuation rates were 15.6% and 15.8%, respectively. More women in the TCu 380A group (18.8%) than in the Lippes Loop group (14.3%) reported genitourinary tract infection during the 12-month study period, but this difference was not significant (p = 0.15). In addition, a nonsignificantly greater number of women in the former group (36.9%) than the latter group (31.8%) experienced dysmenorrhea, intermenstrual bleeding, or intermenstrual pelvic pain (p = 0.20). These findings are generally consistent with previous research.