A three-year longitudinal evaluation of the forearm bone density of users of etonogestrel- and levonorgestrel-releasing contraceptive implants

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to evaluate bone mineral density (BMD) at baseline and at 18 and 36 months of use of etonogestrel (ENG)-and levonorgestrel (LNG)-releasing contraceptive implants. This is a continuation of a previous study in which BMD was evaluated at baseline and at 18 months of use.</p> <p>Methods</p> <p>A total of 111 women, 19–43 years of age, wererandomly allocated to use one of the two implants. At 36 months of follow-up, only 36 and 39 women were still using the ENG- and LNG-releasing implants, respectively. BMD was evaluated at the distal and at the ultra-distal radius of the non-dominant forearm using dual-energy X-ray absorptiometry.</p> <p>Results</p> <p>There was no difference in the BMD of users of either implant at 18 and at 36 months. BMD was significantly lower at 18 and at 36 months at the distal radius in both groups of users compared to pre-insertion values; however, no difference was found at the ultra-distal radius.</p> <p>Conclusion</p> <p>Women 19–43 years of age using either one of these two contraceptive implants for 36 months had lower BMD values at the distal radius compared to pre-insertion values; however, no difference was found at the ultra-distal radius.</p

Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT

Study question: Is pretreatment with misoprostol useful in insertion of intrauterine contraceptives (IUCs) after insertion failure at the first attempt? Summary answer: Pretreatment with intravaginal administration of 200 mcg of misoprostol after IUC insertion failure 10 and 4 h before the second attempt of IUC placement was significantly better than placebo at facilitating the insertion of an IUC. What is known already: One of the reasons for low use of IUCs is the concept that insertion is difficult. Misoprostol was used in several randomized clinical trials (RCT) before IUC insertion to facilitate the insertion. In general, the results showed no significant differences when compared with placebo. However, most previous studies have been carried out among unselected women whereas the present study is among women with previous insertion failure. Study design, size, duration: This was a double blind RCT conducted between February 2013 and October 2014. Participants were 104 women who requested an insertion of an IUC and the insertion failed at the first attempt. After insertion failure, the women received a sealed envelope with misoprostol or placebo. The randomization system (1: 1) in one block size was computer-generated. Participants/materials, setting, methods: The study was conducted at a tertiary care centre. The women were instructed to insert vaginally one tablet of misoprostol 200 µg (Prostokos, Hebron, Cariacica, PE, Brazil) or placebo 10 and 4 h before the woman returned to the clinic for a new insertion attempt. The outcomes were successful IUC insertion and the use of a cervical dilator immediately prior to the insertion procedure. Main results and the role of change: A total of 2639 women requested the insertion of an IUC during the study period. The IUC was inserted at the first attempt in 2535 women (96%) and 104 women in whom we were unable to insert the device were eligible to participate in the RCT. Four women declined and 100 women were randomized (55 for the misoprostol group and 45 for the placebo group). From the 100 participating women, the levonorgestrel-releasing intrauterine system (LNG-IUS) was chosen by 55 and 37 women and the TCu380A intrauterine device (Cu-IUD) was chosen by none and 8 women in the misoprostol and placebo group, respectively. Seven and three women allocated to misoprostol and placebo, respectively, never returned to the clinic after randomization. We placed the IUC in 42 (87.5%) out of the 48 women and in 26 (61.9%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.0066). Regarding the Evaluable Population the relative risk (RR) of successful insertions was 1.41 (95% confidence interval (CI) for absolute difference (8.2, 43.0), P = 0.0066); in the Intent-to-Treat Population the RR (95% CI) was 1.32 (0.3, 36.9). Multiple regression analysis showed that the significant variables associated with the insertion failure were the number of Caesarean section ≥1 (P = 0.020) and the use of placebo (P = 0.026). Dilators were used in 21 (43.7%) out of the 48 and 21 (50%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.804). Limitations, reasons for caution: The limitations were that the majority of the women chose the LNG-IUS, and consequently the data for the Cu-IUD were limited, and there was a small number of nulligravidas. Wider implications of the findings: The results show that IUC insertion difficulties and failures are not common. Pretreatment with intravaginal misoprostol facilitated IUC insertion after failure of insertion at the first attempt, and insertion failure was associated with number of Caesarean sections. Study funding/competing interest(s): This study received partial financial support from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant # 2012/10085-0, and from the National Research Council (CNPq), grant #573747/2008-3. All the TCu380A IUDs were donated by Injeflex, São Paulo, Brazil, and all the LNG-IUS were donated by the International Contraceptive Access Foundation (ICA), Turku, Finland. Both donations were provided in the form of unrestricted grants. The authors declare that there are no conflicts of interest associated with this study.30818611866CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQFUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESP573747/2008-32012/10085-

Effect Of Vaginal Administration Of Misoprostol Before Intrauterine Contraceptive Insertion Following Previous Insertion Failure: A Double Blind Rct.

Is pretreatment with misoprostol useful in insertion of intrauterine contraceptives (IUCs) after insertion failure at the first attempt? Pretreatment with intravaginal administration of 200 mcg of misoprostol after IUC insertion failure 10 and 4 h before the second attempt of IUC placement was significantly better than placebo at facilitating the insertion of an IUC. One of the reasons for low use of IUCs is the concept that insertion is difficult. Misoprostol was used in several randomized clinical trials (RCT) before IUC insertion to facilitate the insertion. In general, the results showed no significant differences when compared with placebo. However, most previous studies have been carried out among unselected women whereas the present study is among women with previous insertion failure. This was a double blind RCT conducted between February 2013 and October 2014. Participants were 104 women who requested an insertion of an IUC and the insertion failed at the first attempt. After insertion failure, the women received a sealed envelope with misoprostol or placebo. The randomization system (1: 1) in one block size was computer-generated. The study was conducted at a tertiary care centre. The women were instructed to insert vaginally one tablet of misoprostol 200 µg (Prostokos, Hebron, Cariacica, PE, Brazil) or placebo 10 and 4 h before the woman returned to the clinic for a new insertion attempt. The outcomes were successful IUC insertion and the use of a cervical dilator immediately prior to the insertion procedure. A total of 2639 women requested the insertion of an IUC during the study period. The IUC was inserted at the first attempt in 2535 women (96%) and 104 women in whom we were unable to insert the device were eligible to participate in the RCT. Four women declined and 100 women were randomized (55 for the misoprostol group and 45 for the placebo group). From the 100 participating women, the levonorgestrel-releasing intrauterine system (LNG-IUS) was chosen by 55 and 37 women and the TCu380A intrauterine device (Cu-IUD) was chosen by none and 8 women in the misoprostol and placebo group, respectively. Seven and three women allocated to misoprostol and placebo, respectively, never returned to the clinic after randomization. We placed the IUC in 42 (87.5%) out of the 48 women and in 26 (61.9%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.0066). Regarding the Evaluable Population the relative risk (RR) of successful insertions was 1.41 (95% confidence interval (CI) for absolute difference (8.2, 43.0), P = 0.0066); in the Intent-to-Treat Population the RR (95% CI) was 1.32 (0.3, 36.9). Multiple regression analysis showed that the significant variables associated with the insertion failure were the number of Caesarean section ≥1 (P = 0.020) and the use of placebo (P = 0.026). Dilators were used in 21 (43.7%) out of the 48 and 21 (50%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.804). The limitations were that the majority of the women chose the LNG-IUS, and consequently the data for the Cu-IUD were limited, and there was a small number of nulligravidas. The results show that IUC insertion difficulties and failures are not common. Pretreatment with intravaginal misoprostol facilitated IUC insertion after failure of insertion at the first attempt, and insertion failure was associated with number of Caesarean sections. This study received partial financial support from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant # 2012/10085-0, and from the National Research Council (CNPq), grant #573747/2008-3. All the TCu380A IUDs were donated by Injeflex, São Paulo, Brazil, and all the LNG-IUS were donated by the International Contraceptive Access Foundation (ICA), Turku, Finland. Both donations were provided in the form of unrestricted grants. The authors declare that there are no conflicts of interest associated with this study. ClinicalTrial.gov NCT01754649.301861-186

Prospective study of the forearm bone mineral density of long-term users of the levonorgestrel-releasing intrauterine system

background: The levonorgestrel-releasing intrauterine system (LNG-IUS) induces amenorrhoea, and its effect on bone mineral density (BMD) may constitute a concern. This study evaluated BMD in long-term users of the LNG-IUS or intrauterine device (IUD). methods: BMD was evaluated at the midshaft of the ulna and ultra-distal radius using dual-energy X-ray absorptiometry in 37 women at 7 or 10 years of use following placement of a second LNG-IUS. The groups were paired for duration of use, age, body mass index (BMI), ethnicity and number of pregnancies. results: The mean age of both LNG-IUS and IUD users at the 7th and 10th year was 34 and 38 years, respectively. Mean BMI was 25 in both groups, increasing to 26 at the 10th year. Amenorrhoea occurred in 51.4 and 91.9% of LNG-IUS users at the 7th and 10th year, respectively. Estradiol levels in LNG-IUS users were normal at both evaluations. There were no differences in BMD (g/cm 2 ) at the midshaft of the ulna nor ultra-distal radius between LNG-IUS and IUD users or between the 7th and 10th years of use in LNG-IUS users. A Z-score below 22SD at the ultra-distal radius was observed in only one LNG-IUS user and in none of the IUD users at the 10th year. Higher BMI and BMD at the seventh year and amenorrhoea were predictors of higher BMD at the 10th year. conclusions: BMD at the midshaft of the ulna and ultra-distal radius in LNG-IUS users were similar to that of IUD users and remained unchanged between the 7th and the 10th years of use

Anticoncepção de emergência no Brasil: facilitadores e barreiras

Realizou-se um estudo multicêntrico (Brasil, Chile e México), qualitativo, para avaliar a aceitabilidade da anticoncepção de emergência entre potenciais usuárias, possíveis provedores, autoridades e outras pessoas influentes, e identificar, de acordo com a percepção dos participantes, facilitadores e barreiras para a utilização do método no Brasil. Realizaram-se entrevistas semi-estruturadas, grupais e grupos de discussão, que foram gravados e transcritos para realização de análise temática. Os participantes manifestaram-se francamente favoráveis à disseminação da informação, provisão e uso da anticoncepção de emergência no Brasil. Consideraram que não existem barreiras significativas a sua aceitação pela sociedade brasileira em geral, e que seria mais apropriado adotar-se a estratégia de inseri-la em programas abrangentes de saúde reprodutiva. O método deveria ser oferecido como mais uma alternativa contraceptiva, em meio às demais, enfatizando a sua indicação em situações de emergência. Além disso, apontou-se como essencial que os profissionais de saúde sejam capacitados para proverem a informação e o método

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.211316-

Anticoncepção de emergência no Brasil: facilitadores e barreiras Emergency contraception in Brazil: facilitators and barriers

Realizou-se um estudo multicêntrico (Brasil, Chile e México), qualitativo, para avaliar a aceitabilidade da anticoncepção de emergência entre potenciais usuárias, possíveis provedores, autoridades e outras pessoas influentes, e identificar, de acordo com a percepção dos participantes, facilitadores e barreiras para a utilização do método no Brasil. Realizaram-se entrevistas semi-estruturadas, grupais e grupos de discussão, que foram gravados e transcritos para realização de análise temática. Os participantes manifestaram-se francamente favoráveis à disseminação da informação, provisão e uso da anticoncepção de emergência no Brasil. Consideraram que não existem barreiras significativas a sua aceitação pela sociedade brasileira em geral, e que seria mais apropriado adotar-se a estratégia de inseri-la em programas abrangentes de saúde reprodutiva. O método deveria ser oferecido como mais uma alternativa contraceptiva, em meio às demais, enfatizando a sua indicação em situações de emergência. Além disso, apontou-se como essencial que os profissionais de saúde sejam capacitados para proverem a informação e o método.<br>A multi-centered qualitative study was conducted in Brazil, Chile, and Mexico to assess the acceptability of emergency contraception both among potential users and possible providers, authorities, and opinion-makers, and to identify (according to participants' perceptions) factors facilitating or hindering the method's use and the most appropriate strategies to disseminate information and provide the method. Data were collected through semi-structured interviews, group interviews, and discussion groups, which were tape-recorded and transcribed. A thematic analysis of this material was conducted. Acceptability of emergency contraception was high among participants, who also felt that there were no barriers towards its acceptance by the population. Participants felt that the method's acceptability would be greater if it were included in reproductive health programs, emphasizing its prescription for emergency situations. Participants highlighted that strategic components in Brazil would be training of providers and inclusion of the method in family planning services