TCu380A Intrauterine Device Users Research Articles

A Randomized Clinical Trial of the Effect of Intensive Versus Non-intensive Counseling on Discontinuation Rates Due to Bleeding Disturbances of Three Long-Acting Reversible Contraceptives

Long-acting reversible contraceptives (LARCs) include the etonogestrel (ENG)–releasing subdermal implant, the levonorgestrel-releasing intrauterine system (LNG-IUS), and the TCu380A intrauterine device (IUD). Despite the high contraceptive efficacy of LARCs, adverse effects may lead to their premature removal, reduce continuation rates, and potentially increase unintended pregnancies. The primary reason for premature discontinuation is unpredictable menstrual bleeding, especially for users of the ENG-implant and the LNG-IUS. Counseling is a well-accepted strategy to improve acceptance, continuation, and satisfaction among contraceptive users and new users. The aim of this randomized clinical trial was to determine whether intensive counseling before insertion and during the first year of use would reduce discontinuation rates due to unpredictable menstrual bleeding in new users of these 3 LARCs. The study was conducted between 2011 and 2013 at an obstetrics-gynecology clinic in Brazil. Contraceptive efficacy and satisfaction rates were investigated for 98 users of the ENG-releasing implant, 99 users of the LNG-IUS, and 100 users of the TCu380A IUD. Each participant had been allowed to choose any one of these methods. Subjects were randomized to 1 of 2 counseling strategies: Women in group I received routine counseling at the clinic, which included information on safety, efficacy, and adverse effects, especially the likelihood of bleeding. Women in group II received the same information, but in addition were given “intensive counseling,” which included leaflets on their chosen method and counseling throughout 1 year of follow-up by the same 3 professionals, who were the most experienced at the clinic. All subjects were instructed to return to the clinic after 45 (+7) days and at 6 and 12 (+1) months after insertion and to record all bleeding episodes in a menstrual diary specifically provided for this purpose. Satisfaction of the women with each contraceptive method was evaluated 12 months after initial use by a questionnaire. No significant differences between the groups or between the 3 contraceptives were found for discontinuation rates due to unpredictable menstrual bleeding. Cumulative discontinuation rates at 1 year due to menstrual bleeding irregularities for the ENG implant, the LNG-IUS, and the TCu380A IUD users were 2.1%, 2.7%, and 4.0%, respectively; continuation rates were 82.6%, 81.0%, and 73.2%. The primary reason for discontinuation was weight gain in users of the ENG implant and expulsion in users of the TCu380A. These data indicate that routine counseling is as effective as intensive counseling in reducing premature discontinuation rates, improving continuation rates, and achieving high satisfaction among new users of LARC methods. However, these findings should be interpreted with caution. The results may not apply to other settings, and premature discontinuation due to menstrual bleeding was already low. Moreover, some women could be discouraged by counseling from using the LARC methods and could decide to use other contraceptives.

A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives.

Does intensive counselling before insertion and throughout the first year of use have any influence on discontinuation rates due to unpredictable menstrual bleeding in users of three long-acting reversible contraceptives (LARCs)? Intensive counselling had a similar effect to routine counselling in terms of discontinuation rates due to unpredictable menstrual bleeding in new users of the contraceptives. Contraceptive efficacy and satisfaction rates are very high with LARCs, including the etonogestrel (ENG)-releasing implant, the levonorgestrel-releasing intrauterine system (LNG-IUS) and the TCu380A intrauterine device (IUD). However, unpredictable menstrual bleeding constitutes the principal reason for premature discontinuation, particularly in the cases of the ENG-implant and the LNG-IUS. A randomized clinical trial was conducted between 2011 and 2013, and involved 297 women: 98 ENG-implant users, 99 LNG-IUS users and 100 TCu380A IUD users. Women accepting each contraceptive method were randomized into two groups after the women chose their contraceptive method. Group I received routine counselling at the clinic, including information on safety, efficacy and side effects, as well as what to expect regarding bleeding disturbances. Group II received 'intensive counselling'. In addition to the information provided to those in Group I, these women also received leaflets on their chosen method and were seen by the same three professionals, the most experienced at the clinic, throughout the year of follow-up. These three professionals went over all the information provided at each consultation. Women in both groups were instructed to return to the clinic after 45 (±7) days and at 6 and 12 (±1) months after insertion. They were instructed to record all bleeding episodes on a menstrual calendar specifically provided for this purpose. Additionally, satisfaction with the method was evaluated by a questionnaire completed by the women after 12 months of use of the contraceptive method. There were no significant differences between the intensive and routine counselling groups on the discontinuation rates due to unpredictable menstrual bleeding of the three contraceptives under evaluation. The 1-year cumulative discontinuation rates due to menstrual bleeding irregularities were 2.1, 2.7 and 4.0% and the continuation rates were 82.6, 81.0 and 73.2%, for the ENG-implant, the LNG-IUS or the TCu380A IUD users, respectively. The main reasons for discontinuation of the methods were weight gain in users of the ENG-implant and expulsion of the TCu380A. The main limitations are that we cannot assure generalization of the results to another settings and that the routine counselling provided by our counsellors may already be appropriate for the women attending the clinic and so consequently intensive counselling including written leaflets was unable to influence the premature discontinuation rate due to unpredictable menstrual bleeding. Additionally, counselling could discourage some women from using the LARC methods offered in the study and consequently those women may have decided on other contraceptives. Routine counselling may be sufficient for many women to help reduce premature discontinuation rates and improve continuation rates and user satisfaction among new users of LARC methods. The trial was registered at clinicaltrials.gov (NCT01392157). The study was partially funded by the Fundação de Apoio a Pesquisa do Estado de São Paulo (FAPESP) grant # 2012/01379-0, the Brazilian National Research Council (CNPq) grant #573747/2008-3 and by Merck (MSD), Brazil under an unrestricted grant. The LNG-IUS were donated by the International Contraceptive Access Foundation (ICA) and the copper IUD by Injeflex, São Paulo, Brazil. L.B. has occasionally served on the Board of MSD, Bayer and Vifor.

Body weight and body composition of depot medroxyprogesterone acetate users

ObjectivesWeight gain is a concern with the contraceptive depot-medroxyprogesterone acetate (DMPA); however, this issue remains controversial. The objective of this study was to compare body weight (BW) and body composition (BC) in DMPA and copper intrauterine device (IUD) users at baseline and after one year of use. Study DesignWe enrolled new DMPA users and age and weight matched new IUD users into this prospective study. Weight and height were measured, BC (fat and lean mass) was evaluated using dual-energy X-ray absorptiometry, and physical activity was assessed at baseline and at 12 months. Student's paired t test and the Wilcoxon paired test for matched samples were used. ResultsNinety-seven women were enrolled for the study; 26 matched pairs continued using the initial method for at least one year, and completed the baseline and 12 month assessments. An increase of 1.9 kg occurred in BW (p=.02) in DMPA users at 12 months of use, resulting from an increase in fat mass of 1.6 kg (p=.03). Weight remained stable in IUD users; however, there was an increase in lean mass at 12 months of use (p=.001). The number of women practicing physical activity increased in this group. There was a significant difference between the groups regarding the variation in the percentage of central fat (p=.04). ConclusionWeight gain in the DMPA group after the first year of use resulted from an increase in fat mass. Weight remained stable in the IUD group; however, an increase in lean mass and a reduction in localized abdominal fat mass occurred, possibly because more users were practicing physical activity. Implications statementThere was a greater increase in body weight in DMPA users compared to TCu380A IUD users in the first year of use of the contraceptive method. Furthermore, the weight increase in users of DMPA occurred principally as the result of an increase in fat mass. Physical activity probably could increase the lean mass in the users of TCu380A IUD.

Body weight and composition in users of levonorgestrel-releasing intrauterine system

BackgroundThere is little information about body weight and body composition (BC) among users of the levonorgestrel-releasing intrauterine system (LNG-IUS). The aim of this study was to evaluate body weight and BC in LNG-IUS users compared to users of the TCu380A intrauterine device (IUD). Study DesignA prospective study was done with 76 new users of both contraceptive methods. Women were paired by age (±2 years) and body mass index (BMI, kg/m2, ±2). Body weight and BC (% lean mass and % fat mass) were evaluated by a trained professional at baseline and at 1 year of contraceptive use. The BC measurements were obtained using Lunar DXA equipment. Weight and BC were evaluated in each woman at baseline and at 12 months and analyzed as the mean change within each woman. Then, the changes in weight and BC for each woman were calculated and then compared between LNG-IUS and TCu380A IUD users (paired data for each woman). The central-to-peripheral fat ratio was calculated by dividing trunk fat by the upper and lower limb fat. ResultsThere were no significant differences at time of IUD insertion between LNG-IUS and TCu380A IUD users regarding age (mean±SD) (34.4±7.5 vs. 33.9±8.0 years), BMI (25.3±4.1 vs. 25.9±4.1) and number of pregnancies (1.9±0.2 vs. 1.7±0.2), respectively. Mean body weight gain of 2.9 kg was observed among LNG-IUS users at 12 months (p=.0012), whereas the body weight of TCu380A IUD users only increased by 1.4 kg (p=.067). There was no significant difference in body weight change between the two groups of users at 12 months. The variation in the central-to-peripheral fat ratio was the same between the two groups (−1.6% vs. −0.2%; p=.364). LNG-IUS users showed a 2.5% gain in fat mass (p=.0009) and a 1.4% loss of lean mass, whereas TCu380A IUD users showed a loss of 1.3% of fat mass (p=.159) and gain of 1.0% of lean mass (p=.120). TCu380A IUD users gained more lean mass than LNG-IUS users (p=.0270), although there was no significant difference between the two groups after 12 months of use. ConclusionsAlthough an increase in mean fat mass among LNG-IUS users at 12 months of use was observed, it should be noted that an increase of body weight was also observed in both groups after 1 year of insertion of the device. However, a study with a larger number of women and long-term evaluation is necessary to evaluate these body changes.

Changes in Bone Mineral Density of Users of the Levonorgestrel-releasing Intrauterine System

The aim of this study was to evaluate changes in bone mineral density (BMD) in patients using a levonorgestrel-releasing intrauterine system (LNG-IUS) or a TCu380A intrauterine device (IUD) after 2 years. The medical records of all patients who underwent LNG-IUS (n=38) or TCu380A IUD (n=26) insertion from May 2006 through December 2010 were reviewed. The patients were 40 to 45 years old at the time of insertion, had undergone a BMD examination of the femur and lumbar spine before the loop insertion, and had also received a follow-up BMD examination 2 years later. Patients were excluded if risk factors known to affect BMD were noted in their medical records. The 2 groups of patients were compared with regard to age, parity, body-mass index (BMI), and levels of osteocalcin and pyridinoline. Changes in BMI, osteocalcin, and pyridinoline after 2 years were also compared. The LNG-IUS and TCu380A IUD groups showed no differences in mean age, mean parity, mean BMI, preinsertion or postinsertion BMD values of the femur or lumbar spine, changes after 2 years in the BMD of the femur or lumbar spine, or changes after 2 years in osteocalcin or pyridinoline level (P>0.05). Women using the LNG-IUS for 2 years have changes in BMD and osteocalcin and pyridinoline levels similar to those of TCu380A IUD users. The use of the LNG-IUS for 2 years may have no adverse effect on BMD.

Length of the endometrial cavity and intrauterine contraceptive device expulsion

Objective To evaluate the correlation between endometrial cavity length and expulsion rate in acceptors of the TCu380A intrauterine device (IUD) or the levonorgestrel-releasing intrauterine system (LNG-IUS). Methods The study included 235 nulligravida and parous women who received a TCu380A IUD or LNG-IUS and who were observed for up to 1 year. The length of the uterine cavity was measured by uterine sounding and ultrasonography. Results The endometrial cavity was shorter than 3.2 cm in 2 LNG-IUS users and at least 3.2 cm long in 87 LNG-IUS users, with expulsions occurring in 0 (0.0%) and 2 (2.3%) of these women, respectively ( P > 0.999). Among the TCu380A IUD users, the endometrial cavity was shorter than 3.6 cm in 63 women and at least 3.6 cm long in 83 women, with expulsions occurring in 3 (4.8%) and 5 (6.0%) of these women, respectively ( P > 0.999). The mean length of the endometrial cavity—evaluated via ultrasonography—among the 10 women whose devices were expelled was 3.9 ± 0.3 cm, compared with 3.9 ± 0.0 cm in those who retained their devices ( P = 0.799). Conclusion The present results do not support the hypothesis of an association between uterine length and risk of intrauterine contraceptive expulsion.

A cross-sectional study of the forearm bone density of long-term users of levonorgestrel-releasing intrauterine system

There are concerns about the effect of hormonal contraceptives on bone mineral density (BMD), but there is currently no information available on the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) on BMD. The objective of this study was to compare the BMD of LNG-IUS users with that of controls using the TCu380A intrauterine device (IUD). A cross-sectional study paired 53 women, aged 25-51 years, who had been using the LNG-IUS for 7 years, with 53 IUD users, according to age (+/-1 year) and body mass index (BMI; kg/m2) (+/-1). BMD was evaluated at the midshaft of the ulna and the distal radius of the nondominant forearm using double X-ray absorptiometry. Mean age of women was 34 years. BMI was slightly over 25 in both groups. Estradiol was normal. Mean BMD was 0.469 +/- 0.008 and 0.467 +/- 0.009 and 0.409 +/- 0.009 and 0.411 +/- 0.009 at the midshaft of the ulna and distal radius in LNG-IUS and IUD users, respectively, without significant differences. Women aged 25-51 years, using the LNG-IUS for 7 years, had a mean BMD similar to that of the control group of TCu380A IUD users.