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Precision medicine carries great potential for management of all tumor types. The aim of this retrospective study was to investigate if the two most common genetically distinct uterine fibroid subclasses, driven by aberrations in MED12 and HMGA2 genes, respectively, influence response to treatment with the progesterone receptor modulator ulipristal acetate. Changes in diameter and mutation status were derived for 101 uterine fibroids surgically removed after ulipristal acetate treatment. A significant difference in treatment response between the two major subclasses was detected. MED12 mutant fibroids had 4.4 times higher odds of shrinking in response to ulipristal acetate treatment as compared to HMGA2 driven fibroids (95% confidence interval 1.37–13.9; P = 0.013), and in a multivariate analysis molecular subclassification was an independent predictive factor. Compatible with this finding, gene expression and DNA methylation analyses revealed subclass specific differences in progesterone receptor signaling. The work provides a proof-of-principle that uterine fibroid treatment response is influenced by molecular subclass and that the genetic subclasses should be taken into account when evaluating current and future uterine fibroid therapies.

PURPOSE: To investigate bleeding profile satisfaction and pain and ease of placement with levonorgestrel 19.5 mg IUD in routine clinical practice. METHODS: Women who independently chose levonorgestrel 19.5 mg IUD during routine counselling were invited to participate in this prospective, multinational, observational study. Patient-reported pain and clinician-reported ease of placement were assessed. Bleeding profile satisfaction was evaluated at 12 months/premature end of observation. RESULTS: Most participants (77.8%, n = 878/1129) rated levonorgestrel 19.5 mg IUD placement pain as 'none' or 'mild' and most clinicians (91.1%, n = 1029/1129) rated placement as 'easy'. Pain was more often rated higher in nulliparous compared with parous (p 35 years. CONCLUSION: We observed high bleeding profile satisfaction regardless of age or parity with levonorgestrel 19.5 mg IUD and confirmed that device placement is easy and associated with no more than mild pain in most cases in routine clinical practice. Real-world evidence from the Kyleena® Satisfaction Study in routine clinical practice shows high bleeding profile satisfaction with levonorgestrel 19.5 mg IUD regardless of age or parity. IUD placement was easy and associated with little to no pain for most women. ispartof: EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE vol:28 issue:1 pages:1-9 ispartof: location:England status: published

Introduction Provision of long-acting reversible contraception (LARC) at surgical abortion is safe, practical, and leads to higher user rates than does delayed provision. The aim of this study was to explore whether provision of LARC at surgical abortion is associated with known risk factors for subsequent abortions and inconsistent use of contraception, including sociodemographic factors and psychiatric disorders. Material and methods This was a register-based cross-sectional study of 6251 women having a surgical abortion in Sweden. Data were collected from National health and population registers. Women with procedure codes for surgical abortion were identified in the National Patient Register from October 2016 to December 2018. Information from Statistics Sweden, the National Patient Register, and the Swedish prescribed drug register on sociodemographic factors, psychiatric disorders, and dispensed LARC was added and linked on an individual level. Associations of sociodemographic factors and psychiatric disorders with LARC provision were explored with generalized logit mixed models and presented as crude and adjusted odds ratios with 95% confidence intervals (CIs). Results The overall rate of LARC provision at the time of the abortion was 2515/6251 (40.2%). Younger age and lower level of education were associated with an increased likelihood of LARC provision. In the study population, 2624/6251 (42.0%) patients had a pre- or post-abortion psychiatric disorder, a factor associated with an increased likelihood of LARC provision compared with women with no such disorders (adjusted odds ratio 1.21; 95% CI 1.08-1.34). The highest rates and odds were seen among women with personality, substance use, and/or neurodevelopmental disorders and among women with multiple psychiatric disorders. Conclusions Sociodemographic risk factors and psychiatric disorders were associated with increased LARC provision at surgical abortion, indicating that women at high risk of unwanted pregnancies are provided with effective contraception. Still, less than half of all women undergoing surgical abortion were provided with LARC, suggesting that contraceptive access and counseling prior to a surgical abortion can be improved.

PURPOSE: Explore contraceptive use, unmet need of and attitudes towards contraceptive use in Sweden. Secondly, to investigate knowledge of contraceptives, prevalence and outcomes of unintended pregnancies. MATERIALS AND METHODS: Internet based e-survey of Swedish women aged 16-49. The e-survey contained 49 questions with both spontaneous and multi-choice character on demographics, contraceptive use, knowledge of and attitudes towards contraception, importance of monthly bleeding, and experience of unintended pregnancy. The e-survey was closed when reaching the estimated sample size of 1000 respondents. RESULTS: A total of 1016 women participated, whereof 62.4% used contraception, 31.8% did not and 5.8% had stopped in the last 12 months. Unmet need for contraception was estimated at 17.2%. At least one unintended pregnancy was experienced by 19.9%. All women rated effectiveness as the most important characteristic of a contraceptive method. CONCLUSIONS: Use of contraception in Swedish women remains low, 62.4%, and the unmet need for contraception has increased to 17.2%. Method effectiveness and health benefits of hormonal contraception should be emphasised during contraceptive counselling, and actions are needed to target groups with low use of effective contraception as well as to reach those who never seek contraception. KEY MESSAGE Close to one third of Swedish women do not use contraception and one fifth have experienced at least one unintended pregnancy. Unmet need for contraception is high despite easy access and subsidies for young women.

Introduction In this open-label, randomized controlled, non-inferiority, multicenter study we aimed to study the risk of termination of pregnancy within 1 year postpartum, the safety profile and patient acceptability after early postpartum insertion of a hormonal intrauterine device (LNG-IUS, Mirena (R)) compared with standard placement 6-8 weeks postpartum. Material and methods April 2018 to January 2020 women with uncomplicated vaginal delivery at four urban birth centers in Sweden, were randomized to either early placement within 48 h after delivery (early group) or standard placement 6-8 weeks postpartum (standard group) of a hormonal intrauterine device. The main outcome measure was the proportion of terminations of pregnancies in each group during the first year after placement of the intrauterine device. Registration EudraCT database no. 2017-001945-29. Results The study was prematurely stopped according to the protocol due to an expulsion rate >20% in the early group. No pregnancies occurred. Fifty-two women were randomized to early and 49 women to standard insertion. In the early group, 23/52 (44.2%) of the intrauterine devices were expelled. After expulsion, 10 women chose to have another hormonal intrauterine device placed but still significantly fewer women (39/52, 75%, p = 0.22) in the early group used the hormonal intrauterine device method at study completion. No expulsions occurred in the standard group, but 5/49 (10.2%) requested removal and 41/49 (83.7%, p = 0.22) had used the hormonal intrauterine device method continuously for 1 year. Conclusions Early hormonal intrauterine device insertion after vaginal delivery is associated with high expulsion rates. Despite this, a high continuation rate of the hormonal intrauterine device method is seen among women once choosing the method. In the light of high continuation rates, the advantages of early insertion could balance the risk of expulsion for well-informed women. Funding Agencies|County Council of Ostergotland (ALF) [LIO-931995, LIO-794921]

Introduction: Intervention trials of structured contraceptive counseling have proved to increase use of long-acting reversible contraceptives (LARCs) and decrease numbers of unintended pregnancies. However, these interventions have not been evaluated from a user perspective. This study aimed to evaluate both healthcare providers’ and participants’ satisfaction with an intervention used in a large trial in Sweden. Material and methods: A cross-sectional study on the intervention group from a cluster randomized trial conducted at 28 clinics in Stockholm, Sweden. Clinics were randomized (1:1 allocation ratio) to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of four parts; an educational video to be seen by the participant prior to contraceptive counseling, key questions to be asked by the healthcare provider, an effectiveness chart, and a box of contraceptive models. Eligible participants were 18 years or older, sexually active without a wish to conceive, and with the main purpose of contraceptive use being pregnancy prevention. Healthcare providers completed an electronic semi-structured survey to evaluate the intervention. This study analyses provider and participant satisfaction with the counseling material used in the intervention and if the intervention was found to be supportive in contraceptive counseling and contraceptive choice. Trial registration: ClinicalTrials.gov (NCT03269357). Results: Fourteen intervention clinics enrolled 658 participants from September 2017 to May 2019. Response rate among providers was 88.0% (55/62) and among participants 97.1% (639/658). Providers found the intervention to be supportive in their counseling. Each separate part of the intervention package received high ratings from both providers and participants. Participants found the educational video and the effectiveness chart to be more helpful than the box of contraceptive models in their contraceptive choice. Providers reported the time taken to complete the intervention outside the study to be time-neutral to standard counseling, and most providers wished to continue to use all parts of the intervention package. Conclusions: The intervention of structured contraceptive counseling had high provider and participant satisfaction. The structured counseling package could be used in several clinical settings to improve quality in contraceptive counseling and to enhance informed decision making about use of contraceptive methods. © 2021 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG)

Purpose: The Kyleena® Satisfaction Study (KYSS) is a prospective, observational study conducted to assess satisfaction with LNG-IUS 12 (Kyleena®) in clinical practice and aims to provide adequate information for counselling women on what to expect regarding insertion and satisfaction.Materials and methods: Women deciding to use LNG-IUS 12 during routine counselling were informed of the study and provided informed consent. A baseline analysis was conducted to evaluate demographics, ease of insertion assessed by investigators, pain at insertion rated by women, additional interventions for insertion, and adverse events.Results: 1,110 women (536 parous, 574 nulliparous) had an insertion attempt and were included. Insertion was rated as easy in 494 (92.2%) parous and 516 (89.9%) nulliparous women. Pain was assessed as none or mild by 475 (88.6%) parous and 387 (67.4%) nulliparous women. Additional interventions were not required for most insertions (705; 63.6%). Overall 111 (10.0%) women reported adverse events at the time of baseline analysis.Conclusions: This analysis demonstrates that LNG-IUS 12 insertion is easy and associated with no or mild pain in most women. Additional interventions for insertion are not required in most cases. After 3 months, the number of adverse events is low.Implications: The present baseline analysis of the Kyleena® Satisfaction Study (KYSS) demonstrates that most women rate insertion pain of LNG-IUS 12 as none or mild and clinicians consider insertion easy in the majority of cases. ispartof: EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE vol:25 issue:3 pages:182-189 ispartof: location:England status: published

Objectives: Approximately, 1–2% of all pregnancies are ectopic; 25% of unintended pregnancies are conceived despite the use of contraception. The primary objective of our study was to explore the proportion of ectopic pregnancies (EPs) that were conceived during contraceptive use among women in Stockholm County. Secondary objectives were to establish the prevalence of contraceptive methods used at the time of EP and the intended contraceptive method after treatment completion. Methods: We performed a retrospective cohort study of 1180 women diagnosed with and treated for EP between 1 December 2013 and 30 April 2017 at all hospitals in Stockholm County. Demographic variables and contraceptive use before and after treatment were noted. Exclusion criteria were uncertainty about the diagnosis of EP in the patient records and planned treatment/follow-up outside Stockholm County. Results: A total of 222/1180 (18.8%) EPs were conceived during known contraceptive use. A total of 112/222 (50.5%) women with known use of contraception at the time of conception discontinued contraceptive use and 81/857 (9.5%) women with no prior use of contraception initiated contraceptive use. Among the 857 women, 520 (60.7%) expressed a desire to conceive. Results were compared using the Mann–Whitney U test or Fisher's exact test as appropriate. Conclusion: EP occurring during use of contraception is an unexplored problem. Contraceptive use decreased in women who were using contraception at the time of EP conception, leaving these women at risk of a subsequent unintended pregnancy. There should be more focus on contraceptive use after treatment for EP, in order to preserve fertility. 目的：大约所有妊娠的1-2％为异位妊娠；尽管使用了避孕措施, 仍有25％概率会意外怀孕。我们研究的主要目的是探讨斯德哥尔摩县妇女在使用避孕药具期间异位妊娠（EPs）的比例。次要目的是确定EP时使用的避孕方法的普及程度以及治疗完成后计划使用的避孕方法。 方法：我们对2013年12月1日至2017年4月30日期间在斯德哥尔摩县所有医院诊断为EP并接受过EP治疗的1180名妇女进行了一项回顾性队列研究。 记录治疗前后的人口统计学变量和避孕药具的使用。排除标准是患者记录中有关EP诊断的不确定性以及斯德哥尔摩县以外地区计划的治疗/随访。 结果：在所有1180例异位妊娠患者中, 已知使用避孕药具的有222（占18.8％）, 共有112/222（50.5％）名妇女在受孕时知道怀孕并停止使用避孕药具, 而81/857名（9.5％）未事先避孕的妇女开始使用避孕药具。在857名妇女中, 有520名（60.7％）表达了受孕的愿望。视情况使用Mann-Whitney U检验或Fisher精确检验比较结果。 结论：在使用避孕药过程中发生EP是一个尚待探讨的问题。使用避孕药具的妇女EP后继续使用避孕药具减少, 使这些妇女处于随后意外怀孕的风险中。为了保护生育力, 应在治疗EP后更注意避孕药具的使用

BackgroundWomen are advised to primarily use non-oral contraceptive alternatives after Roux-en-Y gastric bypass since it is not known if the surgery affects the pharmacokinetics of oral contraceptives.MethodsThis is a multi-center, open label, phase 2 pharmacokinetic study performed at the University Hospital of Linköping and the Clinical Trials Center, Department of Obstetrics and Gynecology, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. Fifteen women aged 18–40 years who had previously undergone Roux-en-Y gastric bypass surgery and reached a BMI 0–24h) was the main outcome measure.ResultsThere were no significant differences in the studied pharmacokinetic parameters, AUC0–24h, total AUC, peak serum concentration (Cmax), time to peak serum concentrations (Tmax), apparent oral clearances of levonorgestrel (CLoral), or terminal half-lives (t½) between the groups.ConclusionThis is to our knowledge the first study to evaluate the pharmacokinetics of oral levonorgestrel in women with a BMI Clinical Trial NumberEudraCT 2014–004677-17.

Preservation of fertility and optimizing health before pregnancy is becoming increasingly important in societies where childbirth often is postponed. Research shows that as women postpone childbirth they achieve higher levels of education and higher incomes. This leads to advantages for their children and for society. However, as women postpone childbearing they are at risk for contracting conditions which may affect fertility and/or pregnancies, pregnancy outcome, and the newborn child. Preconception counseling is therefore becoming increasingly important. Women are often unaware of the added health benefits of contraception and have the right to be well informed so they can make decisions to fulfill their reproductive desires. Contraception can reduce the risk of unintended pregnancies, ectopic and molar pregnancies, and sexually transmitted infections. In addition, hormonal contraceptives reduce the risk of some types of cancer, dysmenorrhea, heavy menstrual bleeding, and anemia and are a treatment for endometriosis. Contraception should increasingly be looked upon as a means of preserving fertility and optimizing health status before a planned pregnancy. Thus, effective contraception can provide women with a possibility of achieving their long-term reproductive goals, although childbearing is actually postponed. The most effective contraceptive methods are the long-acting reversible contraceptives, which have been shown to be highly effective especially in young women who have difficulties with adherence to user-dependent methods. Therefore, these methods should increasingly be promoted in all age groups.

OBJECTIVE: To evaluate whether intrauterine mepivacaine instillation before intrauterine device (IUD) insertion decreases pain compared to placebo. STUDY DESIGN: We performed a double-blind, randomized, controlled trial comparing mepivacaine 1% 10 mL versus 0.9% NaCl intrauterine instillation using a hydrosonography catheter 5 min before IUD insertion in women 18 years of age or older. Participants completed a series of 10-cm visual analogue scales (VAS) to report pain during the procedure. The primary outcome was the difference in VAS scores with IUD insertion between intervention group and placebo. Secondary outcomes included VAS before and after insertion and analgesia method acceptability. RESULTS: We randomized 86 women in a 1:1 ratio; both groups had similar baseline characteristics. In the intention-to-treat analysis, the primary outcome, median VAS with IUD insertion, was 4.8 cm in the intervention group [n=41, interquartile range (IQR) =3.1-5.8] and 5.9 cm in the placebo group (n=40, IQR=3.3-7.5, p=.062). In the per-protocol analysis, the median VAS with IUD insertion was 4.8 cm (IQR=3.1-5.5) and 6.0 cm (IQR=3.4-7.6) for the intervention and placebo groups, respectively (p=.033). More women in the intervention group reported the procedure as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006). CONCLUSION: Intrauterine mepivacaine instillation before IUD insertion modestly reduces pain, but the effect size may be clinically significant. IMPLICATIONS STATEMENT: While the reduction in VAS pain scores did not meet our a priori difference of 1.3 points for clinical significance, participants' favorable subjective reaction suggests that this approach merits further study. Copyright © 2019 Elsevier Inc. All rights reserved. KEYWORDS: Contraception; Intrauterine devices; Mepivacaine; Pain; VAS

Background This cross-sectional pilot study evaluates diagnostic accuracy of live colposcopy versus static image Swede-score evaluation for detecting significant precancerous cervical lesions greater than, or equal to grade 2 severity (CIN2+). Methods VIA or HrHPV positive women were examined using a mobile colposcope, in a rural clinic in Kolkata, India. Live versus static Swede-score colposcopy assessments were made independently. All assessments were by gynecologists, junior or expert. Static image assessors were blinded to live scoring, patient information and final histopathology result. Primary outcome was the ability to detect CIN2+ lesions verified by directed biopsies. Diagnostic accuracy was calculated for live versus static Swede-score in detecting CIN2+ lesions, as well as for interclass correlation. Results 495 images from 94 VIA positive women were evaluated in this study. Thirteen women (13.9%) had CIN2+ on biopsy. No significant difference was found in the detection of CIN2+ lesions between live and static assessors (area under curve = 0.69 versus 0.71, p = 0.63). A Swede-score of 4+, had a sensitivity of 76.9% (95% CI 46.2–95.0%) and 84.6% (95% CI 54.6–98.1%), for live- and static-image assessment respectively. The corresponding positive predictive values were found to be 90.9% (95% CI 75.7–98.1%) and 92.6% (95% CI 75.7–99.1%). The interclass correlation was good (kappa statistic = 0.60) for the senior static assessors. Conclusions Swede-score evaluation of static colposcopy images was found to reliably detect CIN2+ lesions in this study. Larger studies are needed to further develop the colposcopy telemedicine concept which may offer reliable guidance in management where direct specialist input is not available. Trial registration Ethical approval of the study was obtained by the Chittaranjan National Cancer Institute (CNCI) Human Research Ethics Committee (4.311/27/2014). The trial was retrospectively registered in the Clinical Trails Registry of India CTRI/2018/03/012470. Electronic supplementary material The online version of this article (10.1186/s12905-018-0569-1) contains supplementary material, which is available to authorized users.

Objective The aim of this study was to evaluate if levels of gonadotropic and sex steroidal hormones influence the efficacy of mirabegron in the treatment of overactive bladder. Methods We included 58 female participants who received treatment with mirabegron 50 mg once daily and provided a blood sample for hormone profiling before treatment was initiated. Serum hormone concentrations for estradiol, progesterone, testosterone, FSH, LH, TSH, and T4 were analyzed. Urinary Distress Inventory (UDI), (overactive bladder domain: UDIOAB), and the short form Pelvic Floor Impact Questionnaire (PFIQ-7) were used to assess subjective outcomes. Results There were significant overall improvements in UDI, UDIOAB, and the PFIQ from baseline to the 2 months of follow-up (P = 0.001, 0.001, and 0.008, respectively). The magnitude of the mean difference of improvements was similar between pre- and postmenopausal women. Estrogen levels were nonsignificantly lower in participants who experienced an improvement in UDI and UDIOAB at 2 months of follow-up as compared with those that did not (P = 0.7). There were no other clinically relevant differences in hormone levels in relation to improvements in UDI, UDIOAB, or PFIQ. In logistic regression analysis there were no associations between UDIOAB outcomes and age, previous use of anticholinergic drugs, parity, menopause, and local estrogen treatment. Conclusions Estradiol, gonadotropic hormones, thyroid hormones, and testosterone levels did not influence the clinical effects of mirabegron in women with overactive bladder. Menopause status should not be a determinant for mirabegron treatment.

Objective To describe contraceptive use and attitudes towards contraceptive use in Sweden which has the highest abortion rate in Western Europe. Secondary objectives were to investigate knowledge of contraceptive methods and outcomes of unplanned and unwanted pregnancies. Design Telephone survey. Setting National survey of women living in Sweden. Population Women between 16 and 49 years. Methods The survey contained 22 questions with free text and multi choice answers on demographics, contraceptive use, knowledge of and attitudes towards contraception, the importance of monthly bleeding and experience of unintended pregnancy. Main Outcome Measures Distribution of use of contraceptive methods and non-use of contraception among Swedish women. Prevalence and outcome of unintended pregnancies. Results A total of 1001 women participated in the survey. Of all women, 721/1001 (72.1%) currently used contraception whereas 268/1001 (26.8%) women did not. Long acting reversible contraception, (LARC; implant and intra uterine contraception) was used by 24.3% of women. The unmet need of contraception in Sweden was estimated at 8.9% (89/1001 women). A total of 781 (78%) women had never experienced an unintended pregnancy whereas 220 (22%) women had had at least one unintended pregnancy. Users and non-users alike stated that one of the most important characteristics of a contraceptive method is its effectiveness. Conclusions Sweden has a large unmet need for contraception. Furthermore, a large proportion of women have experienced at least one unintended pregnancy. Increasing contraceptive use and promotion of LARC is a possible way forward in the effort to reduce the rates of unwanted pregnancies. Funding Agencies|MSD Sweden