Relationship between user satisfaction with the levonorgestrel-releasing intrauterine system and bleeding patterns.

AIM: Satisfaction with a contraceptive method constitutes an important factor in its acceptance and long-term use. The objective of this study was to assess the relationship between user satisfaction with the 20-µg/day levonorgestrel-releasing intrauterine system (LNG-IUS) and the bleeding patterns reported at two different time-points during follow-up. METHODS: A total of 251 LNG-IUS users aged 18-45 years were invited to answer a questionnaire on their return to the clinic for a routine follow-up visit and again 1 year later. Data were collected face-to-face. RESULTS: Twenty women discontinued prematurely; therefore, the analysis was performed on 231 women. Most users were either highly satisfied (66.6% and 66.2% at the first and second interviews, respectively) or satisfied (26.4% and 26.4% at the first and second interviews, respectively) with the LNG-IUS. Satisfaction was related to amenorrhea (P < 0.001) and duration of use (P < 0.001). Prolonged bleeding and spotting were the main causes of dissatisfaction with the device. CONCLUSION: Most LNG-IUS users in this sample were satisfied with the device. The only two factors associated with satisfaction were amenorrhea and duration of use, while prolonged bleeding and spotting were the main causes of dissatisfaction. These findings could be useful for health-care professionals and policy-makers when developing information material for women. The study provides insight into the profile of satisfied LNG-IUS users; however, this information is not suitable for counseling women who are considering using an LNG-IUS.

Assessment of the quality of cervical mucus among users of the levonorgestrel-releasing intrauterine system at different times of use.

BACKGROUND AND OBJECTIVES: The quality of cervical mucus (CM) among the levonorgestrel-releasing intrauterine system (LNG-IUS) users is controversial. The objectives were to assess CM compared to the levels of oestradiol (E2) and the frequency of cycles with luteal activity among users of the LNG-IUS. MATERIALS AND METHODS: In total, 224 LNG-IUS users for between two months and five years were recruited at a Brazilian family planning clinic. For the cross-sectional part of the study, we enrolled 175 LNG-IUS users at 2, 6 12, 24, 36, 48, and 60 months after insertion (25 women in each group), and we performed one evaluation. For the prospective part of the study, we enrolled 49 LNG-IUS users at the same lengths of use after insertion (7 women in each group), and we evaluated these women once a week for five consecutive weeks. . RESULTS: Mean (± SEM) CM scores of all evaluations among women with single and weekly evaluations were between 3.3 ± 0.9 and 8.5 ± 0.3, respectively independently of the length of use of the LNG-IUS. Mean E2 values ranged from 45.5 ± 6.8 to 472.5 ± 34.7 pg/ml and the maximum ovarian follicle diameter on the days of evaluation varied from 14.0 ± 1.3 to 31.2 ± 0.4 mm. CONCLUSIONS: The mean CM score of all evaluations, independent of the length of use of the LNG-IUS and normal levels of serum E2, was below 10 was according to the WHO is inadequate for sperm penetration.

Gasto energético e medidas antropométricas de novas usuárias do contraceptivo injetável trimestral de acetato de medroxiprogesterona de depósito / Energy expenditure and anthropometric measurements in new users of depot medroxyprogesterone acetate

Objetivo:Avaliar o gasto energético e as medidas antropométricas de mulheres durante o primeiro ano de uso do método contraceptivo de acetato de medroxiprogesterona de depósito.Métodos:Estudo prospectivo com grupo de comparação. Foram incluídas mulheres saudáveis, não obesas, nunca usuárias de acetato de medroxiprogesterona de depósito e sem antecedentes que pudessem contribuir para a variação do peso corporal; foram distribuídas em dois grupos, 28 usuárias de acetato de medroxiprogesterona e 24 usuárias de dispositivo intrauterino de cobre, pareadas por idade (±1 ano) e índice de massa corporal (kg/m2). As variáveis estudadas foram sociodemográficas (idade, etnia, tabagismo, etilismo, atividade física, classe econômica e escolaridade), peso (kg), índice de massa corporal, gasto energético basal e total, medidas de circunferência de cintura e quadril (cm) e relação cintura-quadril.Resultados:A idade das mulheres variou de 20-39 anos. As médias de idade/índice de massa corporal foram 29,6 (DP=±5,2) anos/23,9 (±3,6 kg/m2), no grupo de acetato de medroxiprogesterona de depósito, e de 28,6 (DP=±5,2) anos/ 24,5 (±2,7 kg/m2), no grupo de dispositivo intrauterino de cobre. Após análise de variância para medidas repetidas, as usuárias de acetato de medroxiprogesterona de depósito apresentaram ganho de 2,2 kg no peso corporal e de -0,2 kg no grupo do dispositivo intrauterino de cobre, sem diferença estatisticamente significativa entre eles. Não houve discrepância nas demais variáveis estudadas.Conclusão:Mulheres saudáveis e jovens não apresentaram mudança no peso, nas medidas e nos gastos energéticos durante o primeiro ano de uso do contraceptivo acetato de medroxiprogesterona. A orientação em relação aos hábitos saudáveis de vida e o monitoramento de medidas são importantes para o controle do peso corporal em usuárias de métodos contraceptivos.

Objective:The objective of this study was to assess energy expenditure and the anthropometric profile of women during the first year of use of depot medroxyprogesterone acetate contraception.Methods:This prospective study included healthy non-obese women who had never used depot-medroxyprogesterone acetate and did not have a history of weight fluctuations. The women were divided into two groups composed of 28 depot medroxyprogesterone acetate users and 24 copper intrauterine device (TCu380A) users. They were paired for age (+1 year) and body mass index (+1 kg/m2). The following variables were used: sociodemographic characteristics (age, ethnicity, smoking status, alcohol consumption, physical activity, economic class, and education level), weight (kg), body max index, resting and total energy expenditure, waist and hip circumferences (cm), and waist-to-hip ratio.Results:The age of the women studied ranged from 20-39 years. The mean values of age/body mass index ratio were 29.6 (SD=+5.2) years/23.9 (+3.6 kg/m2) in the depot medroxyprogesterone acetate group and 28.6 (SD=+5.2) years/24.5 (+2.7 kg/m2) in the intrauterine device group. After conducting repeated measures analysis of variance, the users of depot medroxyprogesterone acetate showed weight gain of 2.2 kg, and those in the intrauterine device group showed weight loss of 0.2 kg without statistically significant difference between the groups. There were no significant differences between the other variables.Conclusion:There were no changes in weight, anthropometric measurements, and energy expenditure in the young and healthy women during the first year of use of depot medroxyprogesterone acetate contraception. Guidelines and recommendations for a healthy lifestyle to avoid changes in the anthropometric measurements are important for weight control in users of contraceptive methods.

Prevalence of Low Bone Mass and Osteoporosis in Long-Term Users of the Injectable Contraceptive Depot Medroxyprogesterone Acetate.

BACKGROUND: Bone mineral density (BMD) loss among depot medroxyprogesterone acetate (DMPA) users is a controversial issue. Aspects under debate include whether the number of years of use has any effect on continuous BMD loss, whether this loss will stabilise over the years of use or if it will progress to low bone mass, osteoporosis and an increased fracture risk. The aim of this study was to compare the difference in osteoporosis and low bone mass between DMPA and copper intrauterine device (Cu-IUD) users. METHODS: This was a cross-sectional study that evaluated BMD at the lumbar spine and femoral neck in 47 long-term DMPA users and 41 Cu-IUD users as control group. BMD was measured by dual-energy X-ray absorptiometry. The participants were 27 to 57 years of age, had used either DMPA or a Cu-IUD uninterruptedly for at least ten years, had initiated use of the method prior to 40 years of age and had follicle stimulating hormone values <40 mIU/mL. RESULTS: Findings showed that 68.1% and 36.6% of the DMPA and Cu-IUD users, respectively, had low bone mass and 29.8% and 2.4% of DMPA and Cu-IUD users, respectively, had osteoporosis. BMD decreased as the number of years of DMPA use increased. CONCLUSION: Long-term DMPA use was associated with low bone mass and osteoporosis in women who had used the method for 10 years or more. DMPA users with longer time of use showed a greater bone mass loss.

Body composition and bone mineral density in users of the etonogestrel-releasing contraceptive implant.

PURPOSE: There is scarce information about bone mineral density (BMD) and body composition (BC) among users of the etonogestrel (ENG)-releasing implant. AIMS: To evaluate BC and BMD in ENG-releasing implant users as compared to copper intrauterine device (Cu-IUD)-users. METHODS: A prospective study was conducted on 75 users of both contraceptive methods. BMD was evaluated at femoral neck (FN) and lumbar spine (LS) (L1-L4) and BC at baseline and at 12 months after insertion. RESULTS: The mean (±SD) age was 30.4 ± 6.8 and 29.8 ± 8.4 years and body mass index (kg/m(2)) was 24.9 ± 4.1 and 24.6 ± 3.5 in ENG-releasing implant- and Cu-IUD-users, respectively. ENG-releasing implant users did not show significant differences on BMD at the LS and FN at 12 months of use. Furthermore, ENG-implant users had an increase in body weight at 12 months (p < 0.001) and an increase of 2 % in the percentage of body fat, when compared with Cu-IUD users. There was a significant increase in lean mass in ENG-implant users at 12 months (p = 0.020). CONCLUSIONS: No significant changes of BMD were seen after the first year of use among the ENG-releasing implant-users, albeit an increase of weight and fat mass was seen when compared to Cu-IUD users.

Weight variation in users of depot-medroxyprogesterone acetate, the levonorgestrel-releasing intrauterine system and a copper intrauterine device for up to ten years of use.

BACKGROUND AND OBJECTIVE: Data on record regarding weight variation in depot-medroxyprogesterone acetate (DMPA) and levonorgestrel-releasing intrauterine system (LNG-IUS) users are controversial. To date, no studies have yet evaluated weight variation in DMPA and LNG-IUS users in up to ten years of use compared to non-hormonal contraceptive users. MATERIALS AND METHODS: A retrospective study analysed weight variations in 2138 women using uninterruptedly DMPA (150 mg intramuscularly, three-monthly; n = 714), the LNG-IUS (n = 701) or a copper-intrauterine device (Cu-IUD; n = 723). RESULTS: At the end of the first year of use, there was a mean weight increase of 1.3 kg, 0.7 kg and 0.2 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively, compared to weight at baseline (p < 0.0001). After ten years of use, the mean weight had risen by 6.6 kg, 4.0 and 4.9 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively. DMPA-users had gained more weight than LNG-IUS- (p = 0.0197) and than Cu-IUD users (p = 0.0294), with the latter two groups not differing significantly from each other in this respect (p = 0.5532). CONCLUSION: Users of hormonal and non-hormonal contraceptive methods gained a significant amount of weight over the years. DMPA users gained more weight over the treatment period of up to ten years than women fitted with either a LNG-IUS or a Cu-IUD.

Body composition and weight gain in new users of the three-monthly injectable contraceptive, depot-medroxyprogesterone acetate, after 12 months of follow-up.

OBJECTIVES: To evaluate weight gain and body composition (BC) in new users of depot-medroxyprogesterone acetate (DMPA) as a contraceptive. METHODS: This cohort study followed up 20 DMPA users and 20 copper intrauterine device (TCu380A IUD) users, paired for age (± 1 year) and body mass index (BMI ± 1 kg/m(2)), during 12-months. Healthy, non-obese women aged 18 to 40 years, unaffected by conditions that could influence their body weight, were enrolled. Socio-demographic variables, habits, weight, BMI, BC using dual-energy X-ray absorptiometry, circumferences, skinfold thickness, body fat percentage and waist-to-hip ratio were evaluated. All participants were encouraged to adopt healthy habits. RESULTS: At baseline, median age was 29 and 30.5 years, and mean BMI was 24.8 and 24.5 kg/m(2) in the DMPA and IUD groups, respectively. At 12 months, an increase was observed in waist and hip circumference in the DMPA users and 8/20 of them had a weight gain ≥ 5% (mean 4.6 kg) with accumulation of fat centrally. CONCLUSIONS: There were no differences in weight gain or in BC measurements between the groups; nevertheless 40% of women in the DMPA group had larger weight gain and accumulation of fat centrally. The duration of follow-up may have been insufficient to detect differences between the groups.

Exploratory study of the effect of lifestyle counselling on bone mineral density and body composition in users of the contraceptive depot-medroxyprogesterone acetate.

OBJECTIVES: To compare variations in bone mineral density (BMD) and body composition (BC) in depot-medroxyprogesterone acetate (DMPA) users and nonusers after providing counselling on healthy lifestyle habits. METHODS: An exploratory study in which women aged 18 to 40 years participated: 29 new DMPA users and 25 new non-hormonal contraceptive users. All participants were advised on healthy lifestyle habits: sun exposure, walking and calcium intake. BMD and BC were assessed at baseline and 12 months later. Statistical analysis included the Mann-Whitney test or Student's t-test followed by multiple linear regression analysis. RESULTS: Compared to the controls, DMPA users had lower BMD at vertebrae L1 and L4 after 12 months of use. They also had a mean increase of 2 kg in total fat mass and an increase of 2.2% in body fat compared to the non-hormonal contraceptive users. BMD loss at L1 was less pronounced in DMPA users with a calcium intake ≥ 1 g/day compared to DMPA users with a lower calcium intake. CONCLUSIONS: DMPA use was apparently associated with lower BMD and an increase in fat mass at 12 months of use. Calcium intake ≥ 1 g/day attenuates BMD loss in DMPA users. Counselling on healthy lifestyle habits failed to achieve its aims.

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.

STUDY QUESTION: 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)? SUMMARY ANSWER: 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. WHAT IS KNOWN ALREADY: 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. STUDY DESIGN, SIZE, DURATION: 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. PARTICIPANTS, SETTING, METHODS: 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. MAIN RESULTS AND THE ROLE OF CHANCE: 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. LIMITATIONS, REASONS FOR CAUTION: 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. WIDER IMPLICATIONS OF THE FINDINGS: 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. TRIAL REGISTRATION NUMBER: The trial was registered at clinicaltrials.gov (NCT01392157). STUDY FUNDING/COMPETING INTEREST(S): 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.

Reasons for Brazilian women to switch from different contraceptives to long-acting reversible contraceptives.

OBJECTIVES: Long-acting reversible contraceptives (LARCs) include the copper-releasing intrauterine device (IUD), the levonorgestrel-releasing intrauterine system (LNG-IUS) and implants. Despite the high contraceptive efficacy of LARCs, their prevalence of use remains low in many countries. The objective of this study was to assess the main reasons for switching from contraceptive methods requiring daily or monthly compliance to LARC methods within a Brazilian cohort. STUDY DESIGN: Women of 18-50 years of age using different contraceptives and wishing to switch to a LARC method answered a questionnaire regarding their motivations for switching from their current contraceptive. Continuation rates were evaluated 1 year after method initiation. Sample size was calculated at 1040 women. Clinical performance was evaluated by life table analysis. The cutoff date for analysis was May 23, 2013. RESULTS: Overall, 1167 women were interviewed; however, after 1 year of use, the medical records of only 1154 women were available for review. The main personal reason for switching, as reported by the women, was "fear of becoming pregnant" while the main medical reasons were nausea and vomiting and unscheduled bleeding. No pregnancies occurred during LARC use, and the main reasons for discontinuation were expulsion (in the case of the IUD and LNG-IUS) and a decision to undergo surgical sterilization (in the case of the etonogestrel-releasing implant). Continuation rate was ~95.0/100 women/year for the three methods. CONCLUSIONS: Most women chose a LARC method for its safety and for practical reasons, and after 1 year of use, most women continued with the method.

Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth.

OBJECTIVE: To measure infants' breast milk intake and infant growth when their mothers initiated either combined oral contraceptive (COC), levonorgestrel-releasing intrauterine system, or etonogestrel-releasing implant, or copper intrauterine device (IUD) as a reference group. DESIGN: Prospective trial. SETTING: University-based hospital. PATIENT(S): On postpartum day 42, 40 women initiated a contraceptive method according to their choice. INTERVENTION(S): Deuterium (D2O; 0.5 g/kg mother's weight) was ingested by mothers on postpartum days 42, 52, and 63 as a marker of total body fluid. MAIN OUTCOME MEASURE(S): Infants' milk intake from 42 to 63 postpartum days was assessed by measurement of D2O levels in infants' saliva and infant growth by measuring their body weight, height, and tibia length. Women recorded all infant feed and changes of diapers wet with urine. Breastfeeding continuation was assessed at 6 months postpartum. RESULT(S): Infant mean milk intake, mean growth increase, mean number of breastfeeding episodes, daily wet diaper changes, and mean duration of exclusively breastfeeding (~5 months) were similar in the four groups. CONCLUSION(S): Use of a COC, the two progestin-only contraceptives, or copper IUD did not affect the amount of infant milk intake and growth up to 9 weeks of age. The incidence of full breastfeeding and breastfeeding continuation was similar with contraceptive hormonal use and no use. CLINICAL TRIALS REGISTRATION NUMBER: NCT01388582.

Relationship between chronic pelvic pain and functional constipation in women of reproductive age.

OBJECTIVE: To evaluate the effect of functional constipation on women with and without chronic pelvic pain (CPP). STUDY DESIGN: One hundred women ages 18-50 were separated into three groups: (A) women without CPP, (B) women with CPP but without functional constipation, and (C) women with CPP with functional constipation according to Rome III criteria. All participants were followed over 3 months, completing a questionnaire on pain and constipation daily. CPP was evaluated using a visual analog scale (VAS). RESULTS: In Group A, 16 of 31 women complained of lumpy or hard stools; 13 had symptoms of functional constipation. In Group B, 4 of 19 women had lumpy or hard stools. In Group C, 46 of 50 reported straining or incomplete bowel movements and 49 reported lumpy or hard stools. Regarding CPP, no significant differences were found in VAS pain score between Groups B and C; no changes were found in VAS pain score throughout the 12-week evaluation period. The most common diagnoses associated with CPP were idiopathic pain, endometriosis, and pelvic adhesions. CONCLUSION: Functional constipation was significantly more prevalent in women with CPP than women without CPP; however, it does not appear to have a role in worsening the pain.