Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery.

OBJECTIVE: We compared pain and the ease of insertion of two different types of intrauterine devices (IUDs; the levonorgestrel intrauterine systems 52 mg (LNG-IUS 52 mg) and the copper-bearing IUD [TCu380A]) among nulligravidas and parous women with and without caesarean delivery. METHODS: A cross-sectional study assessed pain referred by women and ease of insertion of the two IUDs models. We applied a visual analogue scale (VAS) to assess pain, while the ease of insertion was defined by healthcare professionals. RESULTS: We assessed 1076 women, including 334 nulligravidas and 566 parous women who had had at least one caesarean delivery and 176 women with history of only vaginal delivery. Regarding pain at IUD placement, 26 (2.5%) women reported no pain, 167 (16.4%) light pain, 319 (31.3%) moderate and 506 (49.7%) intense pain. The highest scores for pain were reported by nulligravidas (67.2%, p = 0.001), while the mean pain score was higher in the LNG-IUS 52 mg group. Difficulties reported by healthcare providers were more frequent in the nulligravidas (21.2%) and women with previous caesarean delivery (16.9%). CONCLUSIONS: Our findings suggested differences between the two IUDs tested, with higher pain associated with the LNG-IUS 52 mg, and highlights the need for pain management, mainly among nulligravida and women with history of caesarean delivery.SHORT CONDENSATIONIntense pain at insertion was more related to nulligravida than parous women and more pain with placement of LNG-IUS 52 mg IUDs than TCu380A IUDs. Nevertheless, our results confirmed that ease of IUD placement was between 80% to 90% of all insertions, being more common in parous women without previous caesarean delivery.

Natural contraception apps knowledge among Brazilian women and Obstetrics and Gynaecology residents.

BACKGROUND: Our objectives were to determine the knowledge and interest in apps for natural contraception among women and Obstetrics and Gynaecology (OBGYN) residents. STUDY DESIGN: An online survey was sent to Brazilian women to gather sociodemographic data, knowledge and interest towards fertility-awareness contraceptive methods and smartphone apps for this purpose. Also, we sent an online survey to OBGYN residents to evaluate the reproductive physiology knowledge of natural contraception and interest in improving it and knowledge and smartphone apps for this purpose. RESULTS: A total of 730 women answered the survey, and 638 were included in the study and 94 OBGYN residents answered the survey. Among the respondent women 386 (60.5%) were interested in more information about natural contraception, 226 (35.5%) showed interest in use natural contraception, 85 (13.3%) indicated that they were users of natural contraception, 15 (16.8%) of this group currently uses an app for this purpose and 485 (76%) considers a practical option to have an app for natural contraception. Regarding the respondent residents all answers were included in the study; 62 (65.9%) knew the right definition of 'Natural Contraception', 52 (55.3%) showed interest in information about this topic and 78 (82.9%) considers a practical option to have an app for natural contraception. CONCLUSIONS: Less than 15% of the respondent women use natural contraception although about 60% expressed some interest in learning more, and that among OBGYN residents, half showed interest.

Practical training of health care providers in insertion of contraceptive implants: findings from two Brazilian centres.

BACKGROUND AND OBJECTIVES: Lack of information and myths or inadequate training of health care providers in the guidance and management of contraceptives could negatively affect choice and eventually continuation rates. Our objectives were to evaluate the impact of clinical and theoretical training of health care professionals on insertion and removal of etonogestrel (ENG)-implant regarding this contraceptive, including pre- and post-training knowledge about insertion and removal techniques, clinical characteristics, side effects and outcomes. MATERIAL AND METHODS: We conducted a cross-sectional study in which a questionnaire was sent to health care providers after they received clinical training in the management of ENG-implant. RESULTS: After training, 78.2% of the 139 participants initiated to offer and inserted up to 5 implants/month and 17.6% between 6 to 10/month. None of the interviewees reported having difficulty with insertions after training, and 87.9% reported feeling very confident for removal. CONCLUSION: Theoretical and practical training appeared important to prepare health care professionals, clarify doubts and promote higher rates of use of contraceptive implants in Brazil, contributing to reduce the rates of unintended pregnancies.

Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial.

BACKGROUND: Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion. OBJECTIVE: To evaluate whether a 3.6-mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas; and, in addition, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure. MATERIALS AND METHODS: In this randomized double-blind controlled trial, nulligravidas were block-randomized to 1 of 3 arms prior to 52-mg levonorgestrel-releasing intrauterine system insertion: 3.6-mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling), or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by healthcare providers), and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analogue scale and a 5-point Faces Pain Scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α = 0.05) to detect a 15% difference in pain score measured by visual analogue scale (mean [standard deviation] visual analogue scale score = 5.9 [2.0] cm) and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used a χ2 test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion. RESULTS: A total of 302 women were randomized (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention), and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P < .0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P < .0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups (intracervical block: 4.3 [3.8-4.9] vs sham: 6.6 [6.2-7.0], P < .0001; intracervical block: 4.3 [3.8-4.9] vs no intervention: 5.8 [5.3-6.4], P < .0001). Women from the intracervical block group reported less pain than expected (P < .0001), rated the insertion as less uncomfortable (P < .0001), and were more willing to undergo another device insertion in the future (P < .01) than women in the other groups. The ease of insertion were similar among groups. The number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively. CONCLUSION: A 3.6-mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.

Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review.

A 2013 review found no evidence to support the routine use of pain relief for intrauterine contraceptive (IUC) placement; however, fear of pain with placement continues to be a barrier to use for some women. This narrative review set out to identify (1) new evidence that may support routine use of pain management strategies for IUC placement; (2) procedure-related approaches that may have a positive impact on the pain experience; and (3) factors that may help healthcare professionals identify women at increased risk of pain with IUC placement. A literature search of the PubMed and Cochrane library databases revealed 550 citations, from which we identified 43 new and pertinent studies for review. Thirteen randomized clinical trials, published since 2012, described reductions in placement-related pain with administration of oral and local analgesia (oral ketorolac, local analgesia with different lidocaine formulations) and cervical priming when compared with placebo or controls. Four studies suggested that ultrasound guidance, balloon dilation, and a modified placement device may help to minimize the pain experienced with IUC placement. Eight publications suggested that previous cesarean delivery, timing of insertion relative to menstruation, dysmenorrhea, expected pain, baseline anxiety, and size of insertion tube may affect the pain experienced with IUC placement. Oral and local analgesia and cervical priming can be effective in minimizing IUC placement-related pain when compared with placebo, but routine use remains subject for debate. Predictive factors may help healthcare professionals to identify women at risk of experiencing pain. Targeted use of effective strategies in these women may be a useful approach while research continues in this area.

Follow-up visits to check strings after intrauterine contraceptive placement cannot predict or prevent future expulsion.

OBJECTIVES: In some settings women are advised to return to the clinic after intrauterine contraceptive (IUC) placement, for a follow-up visit to check the strings and identify any expulsions. Our objective was to evaluate whether the number of follow-up visits to check the strings at the external cervical os after IUC placement predicts or prevents future expulsions. METHODS: This was a retrospective study conducted at the University of Campinas Medical School, Brazil. We reviewed the medical records of all women who used an IUC between January 1980 and December 2017, to identify women who had experienced IUC expulsion (N = 1974). We excluded women whose IUC was expelled more than once (n = 331) or after 10 years of use (n = 31). We fitted a generalised linear model of the time between IUC placement and expulsion, adjusting for several variables at expulsion. Significance was established at p < .05. RESULTS: Most expulsions (843/1612; 52.3%) occurred within the first 6 months after IUC placement and 691/1612 (42.9%) were within the first three months after placement. The adjusted model showed that the number of visits, the woman's age, and complaints of pain and bleeding during use were not significantly associated with and had no influence on expulsion. CONCLUSIONS: Our results indicate that after IUC insertion more than one follow-up visit within the first four to six months after placement is not necessary, as additional visits to check for IUC strings do not appear to reduce or predict future expulsion.

Contraceptive sales in the setting of the Zika virus epidemic.

STUDY QUESTION: Has there been any influence of the Zika virus (ZIKV) outbreak on the sales of contraceptive methods in Brazil? SUMMARY ANSWER: Contraceptive sales in the 24 months of evaluation showed little variation and no significant change has been observed since the ZIKV outbreak. WHAT IS KNOWN ALREADY: Transmission of ZIKV is primarily by Aedes aegypti mosquitoes; however, sexual transmission has also been described. The association of several birth defects and the ZIKV infection during pregnancy has been established, and it was estimated in Bahia, Brazil that the infection rate could range from 10% to 80%. The World Health Organisation (WHO) declared the cluster of microcephaly cases and other neurological disorders a health emergency on 1 February 2016. The Brazilian government also made recommendations for women who were planning to become pregnant and who reside in ZIKV-affected areas to reconsider or postpone pregnancy. STUDY DESIGN, SIZE, DURATION: The objective of this study was to assess the sales of contraceptive methods in Brazil, tracking it from before and through the ZIKV outbreak. We obtained information from all pharmaceutical companies based in Brazil and from the manufacturers of long-acting reversible contraceptives (LARCs), including the copper-intrauterine device (IUD), the levonorgestrel-releasing intrauterine system (LNG-IUS) and implants, about contraceptives sales in the public and private sectors between September 2014 and August 2016. PARTICIPANTS/MATERIALS, SETTING, METHODS: We analyzed the data for: (i) oral contraceptives, i.e. combined oral contraceptives (COC) and progestin-only pills (POP), and vaginal and transdermal contraceptives, (ii) injectable contraceptives, i.e. once-a-month and depot-medroxyprogesterone acetate, (iii) LARCs and (iv) emergency contraceptive (EC) pills. MAIN RESULTS AND THE ROLE OF CHANCE: Monthly sales of COC, POP, patches and vaginal rings represent the major sales segment of the market, i.e. 12.7-13.8 million cycles/units per month (90%). The second largest group of sales was injectables, representing 0.8-1.5 million ampoules per month (9.5%). Following this, are LARC methods with sales of 37 000-41 000 devices per month (0.5%). It is important to note that although the peak months of sales were different for each group of contraceptives, there were no significant differences overall between the months of observation. The EC pill sales were between 1.0 million and 1.3 million of pills per month. LIMITATIONS, REASONS FOR CAUTION: Although the use of contraceptive methods was already high and no change was noted, the ZIKV outbreak may have changed the pregnancy intentions of Brazilian women. Consequently, the number of women planning pregnancy may be lower than that recorded. The contraceptive sales figures did not include condoms. Since condoms might not only prevent pregnancies, but also sexual transmission of ZIKV, this lack of information is a limitation. WIDER IMPLICATIONS OF THE FINDINGS: The results from this assessment showed that the sales of contraceptives presented little variation during the ZIKV outbreak in Brazil. Furthermore, it is possible that access to LARC methods was limited. Although we did not investigate the reason for low LARC uptake, we suspect that it is due to lack of availability of LARC in the public sector, the high cost of the methods and the incomplete insurance coverage on contraception for women. Projections estimate millions of additional cases of ZIKV transmission. Thus, a coordinated response is needed to ensure access to a wide range of contraceptive methods for women during the ZIKV outbreak. In conclusion, this assessment of contraceptive sales in Brazil identifies challenges in contraceptive access, especially for LARC methods, and represents an alternative source of data to help us understand the trends in demand for contraception in ZIKV-affected areas. STUDY FUNDING/COMPETING INTERESTS: This study received partial financial support from Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP) award # 2015/20504-9 and from an anonymous donor. The funding sources did not play a role in the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication. The authors declare no conflict of interest associated with this study. TRIAL REGISTRATION NUMBER: N/A.

Stagnant contraceptive sales after the Zika epidemic in Brazil.

OBJECTIVES: Our aim was to assess national hormonal and non-hormonal contraceptive sales in Brazil after the Zika virus outbreak. METHODS: Pharmaceutical companies based in Brazil provided data on monthly sales from September 2016 to June 2017. Data from both the public and private sectors were obtained about sales of registered, available modern contraceptive methods: combined oral contraceptive pill; progestin-only pill; vaginal and transdermal contraceptives; injectable contraceptives; long-acting reversible contraceptive (LARC) methods, including the copper-releasing intrauterine device, the levonorgestrel-releasing intrauterine system and the etonogestrel-releasing subdermal implant; and emergency contraceptive pills. RESULTS: Seventy-eight percent of sales comprised pills, patches and vaginal rings (11.1-13.8 million cycles/units per month), followed by emergency contraceptive pills (1.8-2.6 million pills), injectables (1.2-1.4 million ampoules) and LARC methods (6500-17,000 devices). CONCLUSIONS: The data showed much higher sales of short-acting methods compared with more effective LARC methods. The public sector needs to strengthen its focus on ensuring better access to LARC methods through a systematic approach ensuring regular supply, improved professional skills and better demand generation to couples wishing to avoid or delay pregnancy. In Zika virus-affected areas, many women of reproductive age may want to delay or postpone pregnancy by using an effective LARC method. The public sector should review its policies on LARC, as the need for these methods especially in Zika virus endemic areas may increase. A clear emphasis on quality in services, access and use is warranted.

Comparison of two strategies for the administration of injectable depot medroxyprogesterone acetate: among women who returned to a family planning clinic at three- or six-month intervals.

OBJECTIVES: The aim of this study was to compare the clinical performance of depot medroxyprogesterone acetate (DMPA) in women who received injections every 3 months at the Family Planning Clinic, and those who received every other injection at a health care facility near their place of residence, only returning to the clinic every 6 months. MATERIALS AND METHODS: The medical charts of DMPA users from 2 January 1980 through 31 December 2012 were evaluated for this study. Two cohorts of women were created and compared: those who regularly received DMPA injections every 3 months (3-month group) at the clinic and those who received alternating 3-month injections at a health care facility near their residence house, returning to the clinic every 6 months for an injection (6-month group). In addition, effectiveness rates, reasons for discontinuation, and continuation rates were evaluated. RESULTS: Overall, 2637 women received all injections at 3-month intervals at the clinic, and 1190 women received every other injection at a health care facility near their residence. The women in the 3-month group had higher pregnancy rates and higher discontinuation rates (with the exception of discontinuation due to the loss of libido). CONCLUSION: The women who received alternating injections near their homes were more likely to continue using DMPA as a contraception method and presented lower pregnancy and discontinuation rates (for the majority of reasons), when compared to those women who returned to the clinic every 3 months.

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.

Estimated disability-adjusted life years averted by long-term provision of long acting contraceptive methods in a Brazilian clinic.

STUDY QUESTION: What is the contribution of the provision, at no cost for users, of long acting reversible contraceptive methods (LARC; copper intrauterine device [IUD], the levonorgestrel-releasing intrauterine system [LNG-IUS], contraceptive implants and depot-medroxyprogesterone [DMPA] injection) towards the disability-adjusted life years (DALY) averted through a Brazilian university-based clinic established over 30 years ago. SUMMARY ANSWER: Over the last 10 years of evaluation, provision of LARC methods and DMPA by the clinic are estimated to have contributed to DALY averted by between 37 and 60 maternal deaths, 315-424 child mortalities, 634-853 combined maternal morbidity and mortality and child mortality, and 1056-1412 unsafe abortions averted. WHAT IS KNOWN ALREADY: LARC methods are associated with a high contraceptive effectiveness when compared with contraceptive methods which need frequent attention; perhaps because LARC methods are independent of individual or couple compliance. However, in general previous studies have evaluated contraceptive methods during clinical studies over a short period of time, or not more than 10 years. Furthermore, information regarding the estimation of the DALY averted is scarce. STUDY DESIGN, SIZE AND DURATION: We reviewed 50 004 medical charts from women who consulted for the first time looking for a contraceptive method over the period from 2 January 1980 through 31 December 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women who consulted at the Department of Obstetrics and Gynaecology, University of Campinas, Brazil were new users and users switching contraceptive, including the copper IUD (n = 13 826), the LNG-IUS (n = 1525), implants (n = 277) and DMPA (n = 9387). Estimation of the DALY averted included maternal morbidity and mortality, child mortality and unsafe abortions averted. MAIN RESULTS AND THE ROLE OF CHANCE: We obtained 29 416 contraceptive segments of use including 25 009 contraceptive segments of use from 20 821 new users or switchers to any LARC method or DMPA with at least 1 year of follow-up. The mean (± SD) age of the women at first consultation ranged from 25.3 ± 5.7 (range 12-47) years in the 1980s, to 31.9 ± 7.4 (range 16-50) years in 2010-2011. The most common contraceptive chosen at the first consultation was copper IUD (48.3, 74.5 and 64.7% in the 1980s, 1990s and 2000s, respectively). For an evaluation over 20 years, the cumulative pregnancy rates (SEM) were 0.4 (0.2), 2.8 (2.1), 4.0 (0.4) and 1.3 (0.4) for the LNG-IUS, the implants, copper IUD and DMPA, respectively and cumulative continuation rates (SEM) were 15.1 (3.7), 3.9 (1.4), 14.1 (0.6) and 7.3 (1.7) for the LNG-IUS, implants, copper IUD and DMPA, respectively (P < 0.001). Over the last 10 years of evaluation, the estimation of the contribution of the clinic through the provision of LARC methods and DMPA to DALY averted was 37-60 maternal deaths; between 315 and 424 child mortalities; combined maternal morbidity and mortality and child mortality of between 634 and 853, and 1056-1412 unsafe abortions averted. LIMITATIONS, REASONS FOR CAUTION: The main limitations are the number of women who never returned to the clinic (overall 14% among the four methods under evaluation); consequently the pregnancy rate could be different. Other limitations include the analysis of two kinds of copper IUD and two kinds of contraceptive implants as the same IUD or implant, and the low number of users of implants. In addition, the DALY calculation relies on a number of estimates, which may vary in different parts of the world. WIDER IMPLICATIONS OF THE FINDINGS: LARC methods and DMPA are highly effective and women who were well-counselled used these methods for a long time. The benefit of averting maternal morbidity and mortality, child mortality, and unsafe abortions is an example to health policy makers to implement more family planning programmes and to offer contraceptive methods, mainly LARC and DMPA, at no cost or at affordable cost for the underprivileged population. STUDY FUNDING/COMPETING INTERESTS: This study received partial financial support from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant # 2012/12810-4 and from the National Research Council (CNPq), grant #573747/2008-3. B.F.B., M.P.G., and V.M.C. were fellows from the scientific initiation programme from FAPESP. Since the year 2001, all the TCu380A IUD were donated by Injeflex, São Paulo, Brazil, and from the year 2006 all the LNG-IUS were donated by the International Contraceptive Access Foundation (ICA), Turku, Finland. Both donations are as unrestricted grants. The authors declare that there are no conflicts of interest associated with this study.

Association between COVID-19 and vaccination on menstrual cycle.

OBJECTIVE: To evaluate changes in the menstrual pattern of women of reproductive age infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or vaccinated against coronavirus disease 2019 (COVID-19). METHODS: A cross-sectional study at the University of Campinas, Brazil using Google questionnaire applied from December 2021 through February 2022, disseminated through snowball technique. Participants responded about characteristics of their menstrual cycle before the pandemic and before COVID-19 vaccination, and then about characteristics of their cycle 3 months after infection with SARS-CoV-2 and 3 months after vaccination. Our primary outcome was a binary indicator of changes in the menstrual cycle. We used multivariate regression analysis to identify factors associated with menstrual changes. RESULTS: We received 1012 completed questionnaires and 735 (72.7%) were from women aged between 20 and 39 years, 745 (73.6%) were White and 491 (48.6%) lived with a partner. A total of 419 (41.6%) of the women reported SARS-CoV-2 infection; however, only two of them were hospitalized, and 995 (98.8%) of women had at least one dose of COVID-19 vaccine. About menstrual characteristics, 170 (41.3%) reported changes after having COVID-19 and 294 (29.9%) after COVID-19 vaccination, respectively. Few years of schooling, lower income, and non-white ethnicity were related to higher reports of menstrual changes after COVID-19. Menstrual changes after COVID-19 vaccination were associated with not using contraception. Higher body mass index was associated with irregularities in cyclicity and bleeding days, after COVID-19 and COVID-19 vaccination, respectively. CONCLUSION: Our results corroborated the stability of the menstrual cycle after having COVID-19 or COVID-19 vaccination; however, there is a potential relationship between menstrual changes and socioeconomic factors as well as contraceptive use.

Gene expression associated with unfavorable vaginal bleeding in women using the etonogestrel subdermal contraceptive implant: a prospective study.

To evaluate gene expression associated with unfavorable vaginal bleeding in users of the Etonogestrel (ENG) contraceptive implant. Prospective study involving 100 women who intended to use the ENG implant. Exclusion criteria included abnormal uterine bleeding, inability to attend a 1-year follow-up, and implant removal for reasons unrelated to vaginal bleeding or loss of follow-up. We obtained endometrial biopsies before implant placement and assessed the expression of 20 selected genes. Users maintained a uterine bleeding diary for 12 months post-implant placement. For statistical analysis, we categorized women into those with or without favorable vaginal bleeding at 3 and 12 months. Women with lower CXCL1 expression had a 6.8-fold increased risk of unfavorable vaginal bleeding at 3 months (OR 6.8, 95% CI 2.21-20.79, p < 0.001), while those with higher BCL6 and BMP6 expression had 6- and 5.1-fold increased risks, respectively. By the 12-month follow-up, women with lower CXCL1 expression had a 5.37-fold increased risk of unfavorable vaginal bleeding (OR 5.37, 95% CI 1.63-17.73, p = 0.006). Women with CXCL1 expression < 0.0675, BCL6 > 0.65, and BMP6 > 3.4 had a higher likelihood of experiencing unfavorable vaginal bleeding at 3 months, and CXCL1 < 0.158 at 12 months. Users of ENG contraceptive implants with elevated BCL6 and BMP6 expression exhibited a higher risk of breakthrough bleeding at the 3-month follow-up. Conversely, reduced CXCL1 expression was associated with an elevated risk of bleeding at both the 3 and 12-month follow-ups.

Knowledge, Attitude, and Practices Related to the SARS-CoV-2 Pandemic among Women Seeking Contraceptive Methods.

OBJECTIVE: To determine knowledge, attitude, and preventive (KAP) practices towards the SARS-CoV-2 (COVID-19) pandemic among women in reproductive age seeking to use copper or hormonal intrauterine devices (IUD/LNG-IUS). METHODS: We conducted a cross-sectional study in which we applied a questionnaire on 400 women about KAP practices on COVID-19 at the University of Campinas, Campinas, SP, Brazil, from May to August 2020. RESULTS: The mean (±SD) age of the women was 30.8 ± 7.9 years, and 72.8% of them reported being pregnant at least once. Most women (95%) had heard or read about COVID-19, and their main sources of information were television (91%) and government websites (53%). However, 53% of the women had doubts about the veracity of the information accessed. CONCLUSION: Women without a partner and with > 12 years of schooling had more information about COVID-19 and on its impact on new pregnancy, and those from high socioeconomic status had a higher chance of maintaining physical distance. Safety, effectiveness, comfort, and absence of hormone in the contraceptive method (in the case of TCu380A IUD) were the main reasons for the participants to seek the service during the pandemic, and the possibility to stop menstrual bleeding was the main reason to choose the LNG-IUS.

OBJETIVO: Determinar o conhecimento, atitude e práticas preventivas (CAP) em relação à pandemia de SARS-CoV-2 (Covid-19) entre mulheres em idade reprodutiva que buscam usar dispositivo intrauterino com cobre (DIU TCu 380) ou sistema intrauterino liberador de levonorgestrel (SIU-LNG). MéTODOS: Foi realizado um estudo transversal e um questionário foi aplicado a 400 mulheres para conhecer o CAP sobre o COVID-19 na Universidade Estadual de Campinas, Campinas, SP, Brasil, no período de maio a agosto de 2020. RESULTADOS: A média (±DP) de idade das mulheres foi de 30,8 ± 7,9 anos, e 72,8% delas relataram ter engravidado pelo menos uma vez. A maioria das mulheres (95%) tinha ouvido ou lido sobre a a Covid-19, e suas principais fontes de informação foram a televisão (91%) e sites do governo (53%). Porém, 53% das mulheres tinham dúvidas a respeito da veracidade das informações acessadas. CONCLUSãO: Mulheres sem companheiro e com mais de 12 anos de escolaridade tiveram mais informações sobre a COVID-19 e sobre o seu impacto em uma nova gravidez, e aquelas de nível socioeconômico alto tiveram maior chance de manter distância física. Segurança, eficácia, conforto e ausência de hormônio no método anticoncepcional (no caso do DIU TCu380A) foram os principais motivos para as participantes procurarem o serviço durante a pandemia, e a possibilidade de controlar o sangramento menstrual abundante foi o principal motivo para a escolha do SIU-LNG.

Expulsion rates of the levonorgestrel 52 mg intrauterine system are similar among women with heavy menstrual bleeding and users for contraception.

OBJECTIVE: To compare the expulsion rates of the levonorgestrel (LNG) 52 mg intrauterine system (IUS) among women with heavy menstrual bleeding versus women using solely for contraception. STUDY DESIGN: We conducted an audit study of 548 (8.8%) women with heavy menstrual bleeding and 5655 (91.2%) users for contraception (comparison group) for 4 years in Campinas, Brazil. We retrieved sociodemographic data, expulsion rates, and variables associated to device placement. Among women with heavy menstrual bleeding, we placed the devices after the cessation of bleeding or after the reduction of menstrual flow. RESULTS: Thirty-one of 548 (5.6%) women with heavy menstrual bleeding and 315 of 5655 (5.6%) from the comparison group expelled the device. This constituted 7.8 expulsions/100 women-years in women with heavy menstrual bleeding and 10.3 expulsions/100 women-years from the comparison group (p = 0.94). Expulsion risk was associated with previous cesarean delivery in both groups (OR 1.93, 95% CI 1.36;2.74). CONCLUSIONS: Expulsion rates of the LNG IUS among women with heavy menstrual bleeding whose IUS was placed after the cessation or reduction of bleeding were similar to expulsion rates among users for contraception. Previous cesarean delivery was a risk factor for expulsion. IMPLICATIONS: We recommend the 52 mg LNG IUS placement after the cessation of bleeding or a reduction of menstrual flow among women with heavy menstrual bleeding because this strategy was associated with similar risk of expulsion when compared to users for contraception.

Cesarean scar defects and abnormal uterine bleeding: a systematic review and meta-analysis.

OBJECTIVE: To synthesize the published literature to better understand the association between cesarean scar defects (CSDs) and abnormal uterine bleeding (AUB). In particular, we aimed to evaluate the risk and pattern(s) of CSD-associated AUB in addition to exploring the relationship between defect morphology with bleeding symptoms. DESIGN: Systematic review and meta-analysis. SETTING: Not applicable. PATIENTS: Patients with CSD and reports of uterine bleeding as an outcome were identified in 60 studies from database searches. INTERVENTIONS: Studies that investigated CSD (as defined by investigators) and reported uterine bleeding, menstrual bleeding, or AUB as an outcome were included. MAIN OUTCOME MEASURES: The prevalence and risk of AUB (intermenstrual, postmenstrual, and unscheduled bleeding) in patients with confirmed CSD. RESULTS: Nine studies reported on the prevalence of AUB in patients with a confirmed CSD. Patients with CSD were more likely to experience AUB, compared with those without CSD (relative risk, 3.47; 95% confidence interval [CI], 2.02-5.97; 6 studies, 1,385 patients; I2 = 67%). In a population of patients with at least 1 cesarean delivery, the prevalence of AUB in those with CSD was 25.5% (95% CI, 14.7-40.5; 6 studies, 667 patients, I2 = 93%). However, symptom prevalence was much higher in patients presenting for imaging for a gynecologic indication where the prevalence of AUB in the presence of a CSD was 76.4% (95% CI, 67.8-83.3; 5 studies, 505 patients; I2 = 71%). The mean menstrual duration in symptomatic patients with CSD was 13.4 days (95% CI, 12.6-14.2; 19 studies, 2,095 patients; I2 = 96%), and the mean duration of early-cycle intermenstrual bleeding was 6.8 days (95% CI, 5.7-7.8 days; 9 studies, 759 patients; I2 = 93%). The most common descriptor of CSD-associated AUB was "brown discharge". Patients with larger CSD experienced more bleeding symptoms. CONCLUSION: There is a strong and consistent association between patients with CSD and AUB. These patients experience a unique bleeding pattern, namely prolonged menstruation and early-cycle intermenstrual bleeding. These data should provide impetus for including CSD as a distinct entity in AUB classification systems. High heterogeneity in our results calls for standardization of nomenclature and outcome reporting for this condition.

Emerging female contraceptives.

INTRODUCTION: Fifty years after the first contraceptive, the market remains restricted regarding composition, cost and routes of administration, and satisfying the needs of millions of women with different requirements according to their stage in life. AREAS COVERED: Women need contraception for almost 30 years of their life. Currently available contraceptives are highly effective with few side effects. This review provides information on emerging female contraceptives including some registered and others at different stages of development. Research efforts aim to reduce costs, improve acceptability and refine 'forgettable' reversible methods. Although developing and testing a new method is laborious and expensive, many new contraceptives are currently under development including different routes of administration. EXPERT OPINION: New methods should be affordable, simple to use and suitable for many women. Much work remains to be done and new methods that act on the fusion process between both gametes are desirable without affecting the hormonal milieu.

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 approximately 34 and 38 years, respectively. Mean BMI was approximately 25 in both groups, increasing to approximately 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 -2SD 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.

Consecutive Use of the 52 mg Levonorgestrel-releasing Intrauterine System: Variations in Bleeding Patterns.

OBJECTIVE: Changes in bleeding patterns could influence the decisions of healthcare professionals to change the levonorgestrel-releasing intrauterine system (LNG-IUS) before 7 years of use, the recommended period of extended use. We evaluated changes in the bleeding patterns of users of the 52 mg LNG-IUS at the end of use of the first (IUS-1) and during the second device (IUS-2) use. METHODS: We performed an audit of the medical records of all women who used two consecutive LNG-IUSs at the Family Planning clinic. We evaluated the sociodemographic/gynecological variables, the length of use, and the bleeding patterns reported in the reference periods of 90 days before removal of the IUS-1 and at the last return in use of IUS-2. We used the McNemar test to compare bleeding patterns. Statistical significance was established at p < 0.05. RESULTS: We evaluated 301 women aged (mean ± SD) 32 (±6.1) years, with lengths of use of 68.9 (±16.8) and 20.3 (±16.7) months for the IUS-1 and IUS-2, respectively. No pregnancies were reported. Bleeding patterns varied significantly among women who used the IUS-2 for ≥ 7 months to 6 years when compared the bleeding patterns reported in IUS-1 use. Eighty-nine out of 221 (40%) women maintained amenorrhea and infrequent bleeding; 66 (30%) evolved to bleeding patterns with light flow, and 66 (30%) maintained or evolved to heavy flow patterns (p = 0.012). No differences were observed among the 80 women with ≤ 6 months of use. CONCLUSION: Changes in bleeding patterns occur during the use of LNG-IUS and should not be decisive for the early replacement of the device.

OBJETIVO: Variações no padrão de sangramento podem afetar a decisão de troca do sistema intrauterino de levonorgestrel (SIU-LNG) antes do período de uso estendido recomendado de 7 anos. Nós avaliamos mudanças no padrão de sangramento de usuárias ao final do uso do primeiro SIU-LNG 52 mg (SIU-1) e durante o uso do segundo dispositivo (SIU-2). MéTODOS: Revisamos os prontuários de todas as mulheres que inseriram consecutivamente o SIU-LNG no ambulatório de Planejamento Familiar. Foram avaliadas as variáveis sociodemográficas/ginecológicas, o tempo de uso, e os padrões de sangramento relatados nos períodos de referência de 90 dias antes da remoção do SIU-1 e no último retorno em uso do SIU-2. Usamos o teste de McNemar para comparar os padrões de sangramento. A significância estatística foi estabelecida em p < 0,05. RESULTADOS: Analisamos os dados de 301 mulheres com idade (média ± desvio padrão [DP]) de 32 (±6,1) anos e tempo de uso de 68,9 (±16,8) e 20,3 (±16,7) meses para o SIU-1 e SIU-2, respectivamente. Nenhuma gravidez foi relatada. Os padrões de sangramento variaram significativamente durante o uso do SIU-2 (≥ 7 meses a 6 anos) em relação ao padrão relatado no SIU-1. Oitenta e nove das 221 (40%) mulheres mantiveram amenorreia e sangramento infrequente; 66 (30%) evoluíram para padrões de sangramento com fluxo leve e 66 (30%) mantiveram ou evoluíram para padrões de fluxo intenso (p = 0,012). Não foram observadas diferenças entre as 80 mulheres que utilizavam o SIU-2 há ≤ 6 meses. CONCLUSãO: Mudanças nos padrões de sangramento ocorrem durante o uso do LNG-IUS e não devem ser decisivas para a troca precoce do dispositivo.

Long-acting reversible contraceptive (LARCs) methods.

Unplanned pregnancy (UP) is a public health problem, which affects millions of women worldwide. Providing long-acting reversible contraceptive (LARC) methods is an excellent strategy to avoid or at least reduce UP, because the effectiveness of these methods is higher than other methods, and is indeed comparable to that of permanent contraception. As the initial introduction of the inert plastic intrauterine device (IUD) and of the six-rod implant, pharmaceutical companies have introduced a copper IUD (Cu-IUD), different models of levonorgestrel-releasing intrauterine system (LNG IUS), and one and two-rod implants, which certainly improved women's LARC options. The main characteristic of LARCs is that they provide high contraceptive effectiveness with a single intervention, and that they can be used for a long time. Emerging evidence from the last few years has demonstrated that it is possible to extend the use of the 52 mg LNG IUS and of the etonogestrel-implant beyond five- and three years, respectively, which adds new value to these LARCs.