Effectiveness and continuation rates of the etonogestrel-subdermal contraceptive implant versus short-acting contraceptive methods offered at no cost in Campinas, Brazil.

OBJECTIVES: To compare the efficacy, reasons for discontinuation and continuation rates of the etonogestrel (ENG)-subdermal contraceptive implant when offered at no cost, and the basis of free choice versus short-acting reversible contraceptive (SARC) methods including combined oral contraceptives (COCs), once-a-month injectables, vaginal ring, and patch. METHODS: We conducted a prospective study at the University of Campinas, Brazil, involving women aged 18 to 40 years. They were counseled on various contraceptive methods before entering the study and followed up every 3 months for up to 24 months. Satisfaction was assessed using a Likert scale. Survival rates were estimated using the Kaplan-Meier test, and curve comparisons were performed using the log-rank test. RESULTS: We enrolled 609 women including 358/609 women (58.8%) who chose the ENG-implant and 251/609 (41.2%) who chose SARC methods. Contraceptive failure and all other reasons for discontinuation were significantly higher in SARC users compared to the ENG-implant users (P < 0.001 and P = 0.002, respectively). The continuation rate was higher among ENG-implant users (89.9% and 75.4%) compared to SARC methods users (27.2% and 15.9%) up to 1 and 2 years after study initiation, respectively. Satisfaction was high in both groups (>82%). CONCLUSIONS: The ENG-implant showed higher contraceptive effectiveness and higher continuation rates than SARC methods up to 2 years after study initiation. Furthermore, users from both groups were highly satisfied with their contraceptive. The main reason for discontinuing use of the ENG-implant was bothersome uterine bleeding, while for SARC methods it was for personal reasons.

Uptake, discontinuation, and continuation rate of long-acting contraceptive methods when offered at no cost in Campinas, Brazil.

OBJECTIVES: This study aimed to compare the uptake, reasons for discontinuation, continuation, and satisfaction of long-acting contraceptive methods (LARC) when offered at no cost in Campinas, Brazil. STUDY DESIGN: This was a prospective cohort study conducted at University of Campinas, Campinas, São Paulo, Brazil, including women aged 18 to 48 years, who adopted one of three methods. Participants underwent telephone follow-up every 3 months for up to 24 months after insertion. Satisfaction was assessed at the end of 2 years of use through the Likert scale. RESULTS: We invited 1222 women, and among the 971 women who volunteered to participate in follow-up, 414 (42.6%) chose the levonorgestrel 52-mg intrauterine device (IUD), 358 (36.9%) chose the etonogestrel (ENG) implant, and 199 (20.5%) chose the TCu380A IUD. Discontinuation due to bothersome bleeding was higher among users of the ENG implant (10/358; 2.4%) and the TCu380A IUD (32/199; 8.9%), and expulsion was higher for the TCu380A IUD (30/199; 15.1%). Women continued at 24 months were 340/414 (82.1%), 270/358 (75.4%), and 119/199 (59.8%) among users of the levonorgestrel 52-mg IUD, ENG implant, and TCu380A IUD, respectively. The users of the levonorgestrel 52-mg IUD (301/339, 88.8%), the ENG-implant (222/270, 82.2%), and the TCu380A IUD (105/119, 88.2%) were satisfied or very satisfied by 24 months of follow-up. CONCLUSIONS: The three LARC methods had great uptake, high continuation, and discontinuation due to bothersome bleeding was higher among users of the ENG implant and the TCu380A IUD, and expulsion was higher for the TCu380A IUD compared to the 52-mg levonorgestrel IUD. Most of the participants reported being very satisfied. IMPLICATIONS: When the LARC methods were offered at no cost in a Brazilian public clinic the uptake, satisfaction and continuation were high by 24 months after device placement, and high level of satisfaction was reported by most of the participants.

Clinical Assessment of 3 Intrauterine Devices in Adolescent Girls: A Randomized Clinical Trial.

STUDY OBJECTIVE: To assess clinical performance, bleeding pattern, dysmenorrhea, and satisfaction up to 1 year after placement of 3 types of intrauterine devices (IUDs) (TCu380A, levonorgestrel 52 mg, and levonorgestrel 19.5 mg) in adolescents METHODS: The study was a randomized trial with 318 adolescents allocated to the 3 IUDs. We assessed reasons for removal, continuation, menstrual patterns, dysmenorrhea, and satisfaction. RESULTS: Participants aged (mean ± SD) 17.9 ± 1.4 years, with 80.8% being nulligravidae. After 1 year, 265 (83.3%) continued using the IUD; however, the continuation rate of TCu380A (75.4 ± 4.2) was lower than that of both the levonorgestrel 52-mg (88.6 ± 3.1) and 19.5-mg IUDs (86.8 ± 3.3), and bleeding/pain and expulsion were the main reasons for removal of the TCu380A IUD. The duration of menstruation was longer among the TCu380A IUD users (6.0 ± 2.0 days) than those using the levonorgestrel 52 mg (2.5 ± 3.9) and 19.5 mg (3.2 ± 3.2) devices, P < .001. Amenorrhea was reported by 49.5% and 37.8% users of the levonorgestrel 52-mg and 19.5-mg devices, respectively, P < .001. Dysmenorrhea was reported in 68.5% of all participants at the baseline; this was 67.9% of the TCu380A group and 33.3% and 36.0% of the levonorgestrel 52-mg and 19.5-mg IUD groups, respectively, P < .001. Satisfaction ranged from 80.7% in the TCu380A group to 97.8% in the levonorgestrel 52-mg group (P = .03). CONCLUSION: The 3 IUDs are suitable for adolescents, with high contraceptive efficacies and rates of continuation within 1 year of use and high degrees of satisfaction. Users of the hormonal IUDs reported lower expulsion rates, more favorable menstrual patterns, and less dysmenorrhea compared with the TCu380A IUD.

Pain and ease of insertion of three different intrauterine devices in Brazilian adolescents: A participant-blinded randomized trial.

OBJECTIVES: To compare pain and ease of insertion of the copper 380 mm2, levonorgestrel 52 mg, and levonorgestrel 19.5-mg intrauterine devices (IUDs) in Brazilian adolescents. STUDY DESIGN: We conducted a participant-blinded randomized trial at two clinics in Brazil. We enrolled 318 adolescents<19 years old in a 1:1:1 ratio from November 2021 to February 2022. We informed the adolescents about the IUD type inserted after they evaluated the pain associated with the IUD insertion using a Visual Analogue Scale and immediately after that the healthcare provider who placed the IUD evaluated the ease of the procedure. RESULTS: The VAS pain level was significantly higher after the levonorgestrel 52-mg IUD placement, median and [interquartile range, IQ] 8.0 [4.0] than the copper 380-mm2 IUD 7.0 [4.0], and the levonorgestrel 19.5-mg IUD 7.0 [6.0] (p = 0.001). The placement was easier after the copper 380-mm2 IUD (87/106, 82.1%) and the levonorgestrel 19.5-mg IUD (91/106, 85.8%) when compared with the levonorgestrel 52-mg IUD (75/105, 70.7%). After multiple logistic regression analyses, the higher VAS pain scores were associated with the levonorgestrel 52-mg IUD (OR = 2.90), low number of pregnancies (OR -0.48), and with a history of dysmenorrhea (OR = 2.67). CONCLUSIONS: The placement of the copper 380-mm2 IUD and the levonorgestrel 19.5-mg IUD was associated with lower pain according to the adolescent and was easier according to the provider when compared with the levonorgestrel 52-mg IUD. However, the small observed differences may not be clinically relevant. IMPLICATIONS: We found that the three types of IUDs were generally easy to place; however, mean pain scores were high during insertions. Our findings of high pain scores reinforce the need for interventions to reduce pain for adolescent IUD insertion.

Reasons reported by women for choosing the levonorgestrel intrauterine system as a contraceptive method.

OBJECTIVE: To assess the reasons provided by women for choosing the use of the 52 mg levonorgestrel intrauterine system (LNG-IUS) as a contraceptive method. METHODS: We conducted a cross sectional study from January 2021 to August 2021 at the University of Campinas, Campinas, SP, Brazil. Women who had never used the 52 mg LNG-IUS and were requesting it for contraception answered a questionnaire asking for their sociodemographic characteristics, the last contraceptive method in use, how they received information about the device, and their main reasons for choosing the method. RESULTS: We enrolled 516 women, 365 (70.7%) of whom were under the age of 35 and 352 (68.2%) of whom were parous. The last contraceptive method in use was a short-acting reversible method among 387 (80.8%) women, 454 (88%) reported that they wanted to use the IUS only for contraception, and the main source of information was their health care providers. The main reported reasons for choosing the method were because it is safe, has high contraceptive efficacy, and reduces menstrual bleeding. CONCLUSION: Health care providers should continue their efforts to provide guidance about the LNG-IUS, including the non-contraceptive benefits, which may contribute to a reduction in the number of unplanned pregnancies.

Postplacental placement of intrauterine devices: A randomized clinical trial.

OBJECTIVE: To compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52 mg intrauterine system (IUS) up to 90 days after postplacental placement (10 min after delivery of the placenta). STUDY DESIGN: Randomized trial (1:1) of women aged 18-43 years and ≥37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion. RESULTS: We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08-15.10; P < 0.00) and higher among women with one (OR 4.38; 95% CI 1.33-14.43; P 0.00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78-20.77; P 0.00) than those with two deliveries. CONCLUSIONS: Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days. IMPLICATIONS: Policy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.

Pregnancy outcomes associated with extended use of the 52-mg 20 µg/day levonorgestrel-releasing intrauterine system beyond 60 months: A chart review of 776 women in Brazil.

OBJECTIVE: To assess the contraceptive performance of the 52-mg 20 µg/day levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena; Bayer Oy, Turku, Finland) among women who maintain the same device without changes after 60 months. STUDY DESIGN: This is a chart review study in which we assessed the charts of 766 women who continue the same LNG-IUS for contraception beyond 60 months. The women were evaluated at the Family Planning clinic, University of Campinas Medical School, Campinas, SP, Brazil, from November 1990 to March 2011. We obtained sociodemographic data, duration of use, continuation and discontinuation rates and reasons, bleeding pattern at the recorded last visit. The statistical analysis was performed using Kaplan-Meier analysis. RESULTS: A total of 776 charts were identified of women who used the LNG-IUS beyond 60 months. The mean age (±S.E.M.) at LNG-IUS placement was 32.0±0.2 years (ranged 15 to 44 years; median was 32 years). The distribution of number of pregnancies was 0-1 (45%); 2-4 (54.1%) and≥5 (0.9%). The median length of the LNG-IUS' use was 73 months after placement (ranged 61-184 months). Zero pregnancies were reported and the main reasons for discontinuation were expiration of approved effective lifespan, menopause and planning pregnancy. The cumulative women-years (W-Y) of exposure were 967 and 1403 up to seven and 15 years, respectively. The main bleeding pattern reported by the women was amenorrhea. CONCLUSIONS: The 52-mg 20 µg/day LNG-IUD (Mirena) showed continue contraceptive efficacy beyond 5 years of use with no pregnancies detected over 967 and 1403 W-Y up to seven and 15 years after placement. IMPLICATIONS STATEMENT: The 52-mg 20 µg/day LNG-IUD presented a very high contraceptive efficacy beyond the first 5 years of lifetime labeled. Increasing data support that efficacy beyond 5 years of use, and new data suggested efficacy as long as 15 years. Healthcare professionals, policy makers and stakeholders could take advantage of the present information to decide to maintain the same device at least up to seven years. Furthermore, amenorrhea could be a good indicator of contraceptive effect.