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2.
Eur J Contracept Reprod Health Care ; 26(2): 105-110, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33539252

RESUMO

PURPOSE: Digital fertility awareness-based contraception offers an alternative choice for women who do not wish to use hormonal or invasive methods. The aim of this study was to investigate the key demographics of current users of the Natural Cycles app and assess the contraceptive outcomes of women preventing pregnancy in a UK cohort of women. MATERIALS AND METHODS: This was a real world observational prospective observational study. The typical-use effectiveness of the method was calculated using both 13-cycle cumulative probability of pregnancy (life table analysis) and Pearl Index for the entire study cohort. Perfect-use PI was calculated using data from cycles where sexual intercourse during the fertile window was marked as protected and no unprotected sex was recorded on fertile days. RESULTS: 12,247 women were included in the study and contributed an average of 9.9 months of data for a total of 10,066 woman years of exposure. The mean age of the cohort was 30, mean BMI 23.4, the majority were in a stable relationship (83.2%) and had a university degree or higher (83%). The one year typical use, PI was 6.1 (95% CI: 5.6, 6.6) and with perfect-use was 2.0 (95% CI: 1.3, 2.8). 13 cycle pregnancy probability was 7.1%. CONCLUSIONS: This is the first study which describes the use of a digital contraceptive by women in the UK. It describes the demographics of users and how they correlate with the apps effectiveness at preventing pregnancy.

3.
Acta Obstet Gynecol Scand ; 100(4): 614-618, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33544887

RESUMO

Since its introduction in 1990, the levonorgestrel-releasing intrauterine system (LNG-IUS) has played a key role in shaping the healthcare landscape of women. Here we explore the development of the first LNG-IUS (Mirena®) and the early clinical trials that demonstrated its potential. We highlight the contraceptive and therapeutic benefits of Mirena®, and discuss how clinical practice has been changed since the introduction of LNG-IUS and other long-acting reversible contraceptive methods. The history of Mirena® is rich in innovation and has also paved the way to the development of smaller intrauterine systems with lower hormone doses. Along with Mirena®, these newer LNG-IUS contribute to improving contraceptive choices for women, allowing them to select the option that is right for them and that meets their needs no matter their age, parity or circumstances.

4.
BMJ Glob Health ; 6(2)2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33547174

RESUMO

INTRODUCTION: With a view to inform policy for improved postabortion care, we describe abortion-related near-miss and mortality by sociodemographic risk factors and management options by pregnancy trimester in Uganda. METHODS: This secondary data analysis used an adapted WHO near-miss methodology to collect cross-sectional maternal near-miss and abortion complications data at 43 health facilities in Central and Eastern Uganda in 2016-2017. We computed abortion severe morbidity, near-miss and mortality ratios per 100 000 live births, and described the proportion of cases that worsened to an abortion near-miss or death, stratified by geographical region and trimester. We tested for association between independent variables and abortion near-miss, and obtained prevalence ratios for association between second trimester near-miss and independent demographic and management indicators. We assessed health facility readiness for postabortion care provision in Central and Eastern regions. RESULTS: Of 3315 recorded severe abortion morbidity cases, 1507 were near-misses. Severe abortion morbidity, near-miss and mortality ratios were 2063, 938 and 23 per 100 000 live births, respectively. Abortion-related mortality ratios were 11 and 57 per 100 000 in Central and Eastern regions, respectively. Abortion near-miss cases were significantly associated with referral (p<0.001). Second trimester had greater abortion mortality than first trimester. Eastern region had greater abortion-related morbidity and mortality than Central region with facilities in the former characterised by inferior readiness to provide postabortion care. CONCLUSIONS: Uganda has a major abortion near-miss morbidity and mortality; with mortality higher in the second trimester. Life-saving commodities are lacking especially in Eastern region compromising facility readiness for postabortion care provision.

5.
Artigo em Inglês | MEDLINE | ID: mdl-33452056

RESUMO

OBJECTIVE: The study aim was to establish which demographic, clinical, reproductive and psychiatric factors are associated with self-reported hormonal contraceptive (HC)-induced adverse mood symptoms. STUDY DESIGN: We compiled baseline data from two Swedish studies: one cross-sectional study on combined oral contraceptive (COC)-induced adverse mood symptoms (n=118) and one randomised controlled trial on adverse mood symptoms on COC (n=184). Both included women eligible for COC use, aged over 18 years. All women answered a questionnaire on HC use and associated mood problems. The Mini-International Neuropsychiatric Interview (M.I.N.I.) was used to capture mood and anxiety disorders. Women who acknowledged HC-induced adverse mood symptoms, ongoing or previously (n=145), were compared with women without any such experience (n=157). RESULTS: Compared with women without self-reported HC-induced adverse mood symptoms, women with these symptoms were younger at HC start (adjusted odds ratio (aOR) 0.83, 95% CI 0.72 to 0.95), had more often undergone induced abortion (OR 3.36, 95% CI 1.57 to 7.23), more often suffered from an ongoing minor depressive disorder (n=12 vs n=0) and had more often experienced any previous mental health problem (aOR 1.90, 95% CI 1.01 to 3.59). CONCLUSIONS: In line with previous research, this study suggests that women with previous or ongoing mental health problems and women who are younger at HC start are more likely to experience HC-induced adverse mood symptoms. Former and current mental health should be addressed at contraceptive counselling, and ongoing mental health disorders should be adequately treated. IMPLICATIONS: This study adds valuable knowledge for identification of women susceptible to HC-induced adverse mood symptoms. It should facilitate the assessment of whether or not a woman has an increased risk of such symptoms, and thus enable clinicians to adopt a more personalised approach to contraceptive counselling.

6.
Artigo em Inglês | MEDLINE | ID: mdl-33514606

RESUMO

Universal access to sexual and reproductive health services is essential to facilitate the empowerment of women and achievement of gender equality. Increasing access to modern methods of contraception can reduce the incidence of unplanned pregnancy and decrease maternal mortality. Long-acting reversible contraceptives (LARCs) offer high contraceptive efficacy as well as cost-efficacy, providing benefits for both women and healthcare systems. The levonorgestrel-releasing intrauterine system (LNG-IUS) first became available in 1990 with the introduction of Mirena (LNG-IUS 20), a highly effective contraceptive which can reduce menstrual blood loss and provide other therapeutic benefits. The impact of the LNG-IUS on society has been wide ranging, including decreasing the need for abortion, reducing the number of surgical sterilisation procedures performed, as well as reducing the number of hysterectomies carried out for issues such as heavy menstrual bleeding (HMB). In the context of the COVID-19 pandemic, Mirena can provide a treatment option for women with gynaecological issues such as HMB without organic pathology, minimising exposure to the hospital environment and reducing waiting times for surgical appointments. Looking to the future, research and development in the field of the LNG-IUS continues to expand our understanding of these contraceptives in clinical practice and offers the potential to further expand the choices available to women, allowing them to select the option that best meets their needs.

7.
Artigo em Inglês | MEDLINE | ID: mdl-33370220

RESUMO

Background: Digital fertility awareness-based methods of birth control are an attractive alternative to hormonal or invasive birth control for modern women. They are also popular among women who may be planning a pregnancy over the coming years and wish to learn about their individual menstrual cycle. The aim of this study was to assess the effectiveness of the Natural Cycles app at preventing pregnancy for a cohort of women from the United States and to describe the key demographics of current users of the app in such a cohort. Materials and Methods: This prospective real-world cohort study included users who purchased an annual subscription to prevent pregnancy. Demographics were assessed through answers to in-app questionnaires. Birth control effectiveness estimates for the entire cohort were calculated using 1-year pearl index (PI) and 13-cycle cumulative pregnancy probability (Kaplan-Meier life table analysis). Results: The study included 5879 women who contributed an average of 10.5 months of data for a total of 5125 woman-years of exposure. The average user was 30 years old with a body mass index of 24 and reported being in a stable relationship. With typical use, the app had a 13-cycle cumulative pregnancy probability of 7.2% and a 1-year typical use PI of 6.2. When the app was used under perfect use, the PI was 2.0. Conclusions: The data presented in this study give insights into the cohort of women using this app in the United States, and provide country-specific effectiveness estimates. The contraceptive effectiveness of the app was in line with previously published figures from Natural Cycles (PI of seven for typical use and two for perfect use).

8.
Adv Ther ; 2020 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-33247314

RESUMO

INTRODUCTION: Up to one-third of women of reproductive age experience heavy menstrual bleeding (HMB). HMB can give rise to iron deficiency (ID) and, in severe cases, iron-deficiency anemia (IDA). AIM: To review current guidelines for the management of HMB, with regards to screening for anemia, measuring iron levels, and treating ID/IDA with iron replacement therapy and non-iron-based treatments. METHODS: The literature was searched for English-language guidelines relating to HMB published between 2010 and 2020, using the PubMed database, web searching, and retrieval of clinical guidelines from professional societies. RESULTS: Overall, 55 guidelines mostly originating from North America and Europe were identified and screened. Twenty-two were included in this review, with the majority (16/22) focusing on guidance to screen women with HMB for anemia. The guidance varied with respect to identifying symptoms, the criteria for testing, and diagnostic hemoglobin levels for ID/IDA. There was inconsistency concerning screening for ID, with 11/22 guidelines providing no recommendations for measurement of iron levels and four contrasting guidelines explicitly advising against initial assessment of iron levels. In terms of treatment, 8/22 guidelines provided guidance on iron therapy, with oral iron administration generally recommended as first-line treatment for ID and/or IDA. Four guidelines recommended intravenous iron administration for severe anemia, in non-responders, or before surgery. Three guidelines provided hemoglobin thresholds for choosing between oral or intravenous iron treatment. Four guidelines discussed the use of transfusion for severe IDA. CONCLUSION: Many of the guidelines for managing HMB recognize the importance of treating anemia, but there is a lack of consensus in relation to screening for ID and use of iron therapy. Consequently, ID/IDA associated with HMB is likely to be underdiagnosed and undertreated. A consensus guidance, covering all aspects of screening and management of ID/IDA in women with HMB, is needed to optimize health outcomes in these patients.

9.
Int J Gynaecol Obstet ; 150 Suppl 1: 34-42, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33219992

RESUMO

We performed a country case study using thematic analysis of interviews and existing grey and published literature to identify facilitators and barriers to the implementation of midwife-provided abortion care in Sweden. Identified facilitating factors were: (1) the historical role and high status of Swedish midwives; (2) Swedish research and development of medical abortion that enabled an enlarged clinical role for midwives; (3) collaborations between individual clinicians and researchers within the professional associations, and the autonomy of clinical units to implement changes in clinical practice; (4) a historic precedent of changes in abortion policy occurring without prior official or legal sanction; (5) a context of liberal abortion laws, secularity, gender equality, public support for abortion, trust in public institutions; and (6) an increasing global interest in task-shifting to increase access and reduce costs. Identified barriers/risks were: (1) the lack of systems for monitoring and evaluation; and (2) a loss of physician competence in abortion care.

10.
Artigo em Inglês | MEDLINE | ID: mdl-33179265

RESUMO

INTRODUCTION: We aimed to give a global overview of trends in access to sexual and reproductive health and rights (SRHR) during the coronavirus disease 2019 (COVID-19) pandemic and what is being done to mitigate its impact. MATERIAL AND METHODS: We performed a descriptive analysis and content analysis based on an online survey among clinicians, researchers, and organizations. Our data were extracted from multiple-choice questions on access to SRHR services and risk of SRHR violations, and written responses to open-ended questions on threats to access and required response. RESULTS: The survey was answered by 51 people representing 29 countries. Eighty-six percent reported that access to contraceptive services was less or much less because of COVID-19, corresponding figures for surgical and medical abortion were 62% and 46%. The increased risk of gender-based and sexual violence was assessed as moderate or severe by 79%. Among countries with mildly restrictive abortion policies, 69% had implemented changes to facilitate access to abortion during the pandemic, compared with none among countries with severe restrictions (P < .001), 87.5% compared with 46% had implemented changes to facilitate access to contraception (P = .023). The content analysis showed that (a) prioritizations in health service delivery at the expense of SRHR, (b) lack of political will, (c) the detrimental effect of lockdown, and (d) the suspension of sexual education, were threats to SRHR access (theme 1). Requirements to mitigate these threats (theme 2) were (a) political will and support of universal access to SRH services, (b) the sensitization of providers, (c) free public transport, and (d) physical protective equipment. A contrasting third theme was the state of exception of the COVID-19 pandemic as a window of opportunity to push forward women's health and rights. CONCLUSIONS: Many countries have seen decreased access to and increased violations of SRHR during the COVID-19 pandemic. Countries with severe restrictions on abortion seem less likely to have implemented changes to SRHR delivery to mitigate this impact. Political will to support the advancement of SRHR is often lacking, which is fundamental to ensuring both continued access and, in a minority of cases, the solidification of gains made to SRHR during the pandemic.

11.
Ann Rheum Dis ; 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33004330

RESUMO

OBJECTIVE: Congenital heart block (CHB) with immune cell infiltration develops in the fetus after exposure to maternal Ro/La autoantibodies. CHB-related serology has been extensively studied, but reports on immune-cell profiles of anti-Ro/La-exposed neonates are lacking. In the current study, we characterised circulating immune-cell populations in anti-Ro/La+mothers and newborns, and explored potential downstream effects of skewed neonatal cell populations. METHODS: In total, blood from mothers (n=43) and neonates (n=66) was sampled at birth from anti-Ro/La+ (n=36) and control (n=30) pregnancies with or without rheumatic disease and CHB. Flow cytometry, microarrays and ELISA were used for characterising cells and plasma. RESULTS: Similar to non-pregnant systemic lupus erythematosus and Sjögren-patients, anti-Ro/La+mothers had altered B-cell subset frequencies, relative T-cell lymphopenia and lower natural killer (NK)-cell frequencies. Surprisingly, their anti-Ro/La exposed neonates presented higher frequencies of CD56dimCD16hi NK cells (p<0.01), but no other cell frequency differences compared with controls. Type I and II interferon (IFN) gene-signatures were revealed in neonates of anti-Ro/La+ pregnancy, and exposure of fetal cardiomyocytes to type I IFN induced upregulation of several NK-cell chemoattractants and activating ligands. Intracellular flow cytometry revealed IFNγ production by NK cells, CD8+ and CD4+ T cells in anti-Ro/La exposed neonates. IFNγ was also detectable in their plasma. CONCLUSION: Our study demonstrates an increased frequency of NK cells in anti-Ro/La exposed neonates, footprints of type I and II IFN and an upregulation of ligands activating NK cells in fetal cardiac cells after type I IFN exposure. These novel observations demonstrate innate immune activation in neonates of anti-Ro/La+pregnancy, which could contribute to the risk of CHB.

12.
Artigo em Inglês | MEDLINE | ID: mdl-33093040

RESUMO

BACKGROUND: Unprecedented public health actions restricting movement and non-COVID related health services are likely to have affected abortion care during the pandemic in Europe. In the absence of a common approach to ensure access to this essential health service, we sought to describe the variability of abortion policies during the outbreak in Europe in order to identify strategies that improve availability and access to abortion in times of public health crises. METHODS: We collected information from 46 countries/regions: 31 for which country-experts completed a survey and 15 for which we conducted a desk review. We describe abortion regulations and changes to regulations and practice during the pandemic. RESULTS: During COVID-19, abortions were banned in six countries and suspended in one. Surgical abortion was less available due to COVID-19 in 12 countries/regions and services were not available or delayed for women with COVID-19 symptoms in eleven. No country expanded its gestational limit for abortion. Changes during COVID-19, mostly designed to reduce in-person consultations, occurred in 13 countries/regions. Altogether eight countries/regions provided home medical abortion with mifepristone and misoprostol beyond 9 weeks (from 9 weeks+6 days to 11 weeks+6 days) and 13 countries/regions up to 9 weeks (in some instances only misoprostol could be taken at home). Only six countries/regions offered abortion by telemedicine. CONCLUSIONS: The lack of a unified policy response to COVID-19 restrictions has widened inequities in abortion access in Europe, but some innovations including telemedicine deployed during the outbreak could serve as a catalyst to ensure continuity and equity of abortion care.

13.
Hum Reprod ; 35(10): 2280-2293, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-32897364

RESUMO

STUDY QUESTION: What is the physiological role of transforming growth factor-beta (TGF-ß1) and syndecans (SDC1, SDC4) in endometriotic cells in women with endometriosis? SUMMARY ANSWER: We observed an abnormal, pro-invasive phenotype in a subgroup of samples with ovarian endometriosis, which was reversed by combining gene silencing of SDC1 with the TGF-ß1 treatment. WHAT IS KNOWN ALREADY: Women with endometriosis express high levels of TGF-ß1 and the proteoglycan co-receptors SDC1 and SDC4 within endometriotic cysts. However, how SDC1 and SDC4 expression is regulated by TGF-ß1 and the physiological significance of the high expression in endometriotic cysts remains unknown as does the potential role in disease severity. STUDY DESIGN, SIZE, DURATION: We utilized a pre-validated panel of stem- and cancer cell-associated markers on endometriotic tissue (n = 15) to stratify subgroups of women with endometriosis. Furthermore, CD90+CD73+CD105+ (SC+) endometriotic stromal cells from these patient subgroups were explored for their invasive behaviour in vitro by transient gene inhibition of SDC1 or SDC4, both in the presence or absence of TGF-ß1 treatment. PARTICIPANTS/MATERIALS, SETTING, METHODS: Endometriotic cyst biopsies (n = 15) were obtained from women diagnosed with ovarian endometriosis (ASRM Stage III-IV). Gene expression variability was assessed on tissue samples by applying gene clustering tools for the dataset generated from the pre-validated panel of markers. Three-dimensional (3D) spheroids from endometriotic SC+ were treated in vitro with increasing doses of TGF-ß1 or the TGFBRI/II inhibitor Ly2109761 and assessed for SDC1, SDC4 expression and in vitro 3D-spheroid invasion. Transcriptomic signatures from the invaded 3D spheroids were evaluated upon combining transient gene silencing of SDC1 or SDC4, both in presence or absence of TGF-ß1 treatment. Furthermore, nanoscale changes on the surface of endometriotic cells were analysed after treatment with TGF-ß1 or TGFBRI/II inhibitor using atomic force microscopy. MAIN RESULTS AND THE ROLE OF CHANCE: Gene clustering analysis revealed that endometriotic tissues displayed variability in their gene expression patterns; a small subgroup of samples (2/15, Endo-hi) exhibited high levels of SDC1, SDC4 and molecules involved in TGF-ß signalling (TGF-ß1, ESR1, CTNNB1, SNAI1, BMI1). The remaining endometriotic samples (Endo-lo) showed a uniform, low gene expression profile. Three-dimensional spheroids derived from Endo-hi SC+ but not Endo-lo SC+ samples showed an aberrant expression of SDC1 and exhibited enhanced 3D-spheroid invasion in vitro, upon rhTGF-ß1 treatment. However, this abnormal, pro-invasive response of Endo-hi SC+ was reversed upon gene silencing of SDC1 with the TGF-ß1 treatment. Interestingly, transcriptomic signatures of 3D spheroids silenced for SDC1 and consecutively treated with TGF-ß1, showed a down-regulation of cancer-associated pathways such as WNT and GPCR signalling. LARGE SCALE DATA: Transcriptomic data were deposited in NCBI's Gene Expression Omnibus (GEO) and could be retrieved using GEO series accession number: GSE135122. LIMITATIONS, REASONS FOR CAUTION: It is estimated that about 2.5% of endometriosis patients have a potential risk for developing ovarian cancer later in life. It is possible that the pro-oncogenic molecular changes observed in this cohort of endometriotic samples may not correlate with clinical occurrence of ovarian cancer later in life, thus a validation will be required. WIDER IMPLICATIONS OF THE FINDINGS: This study emphasizes the importance of interactions between syndecans and TGF-ß1 in the pathophysiology of endometriosis. We believe that this knowledge could be important in order to better understand endometriosis-associated complications such as ovarian cancer or infertility. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by Cancerfonden (CAN 2016/696), Radiumhemmets Forskningsfonder (Project no. 154143 and 184033), EU MSCA-RISE-2015 project MOMENDO (691058), Estonian Ministry of Education and Research (IUT34-16), Enterprise Estonia (EU48695) and Karolinska Institute. Authors do not have any conflict of interest.

14.
Eur J Obstet Gynecol Reprod Biol ; 254: 38-43, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32920421

RESUMO

OBJECTIVE: Vaginal bromocriptine significantly reduces heavy menstrual bleeding and pain in women with diffuse adenomyosis. The aim of this pilot study was to evaluate whether imaging findings of adenomyosis, as assessed by transvaginal ultrasound (TVU) and magnetic resonance imaging (MRI) reflect changes induced by the bromocriptine treatment. STUDY DESIGN: Eighteen women, aged 35-50, with heavy menstrual bleeding reporting Pictorial Blood Loss Assessment Chart (PBLAC) scores >100 and diffuse adenomyosis according to both MRI and TVU were included. The subjects underwent treatment with vaginal bromocriptine for 6 months. MRI and TVU were performed at baseline and after 6 months of medication. RESULTS: Mean age of the participants was 44.8 years, 77.8 % reported PBLAC scores > 250 and 66.7 % reported moderate to severe pain during menstruation at baseline. As compared to baseline, TVU revealed a thinner maximal Junctional Zone (JZmax) (8.5 mm [5.2-14] vs 7.9 mm [5-11.2], p = 0.02) at 6 months. Asymmetric wall thickening was seen in 13 (72 %) at baseline, and in 6 (33 %) women at 6 months, p = 0.02. No significant changes were seen in irregular endometrial-myometrial border, presence of fan-shaped shadowing, cystic changes, striations, hyperechogenic islands or lesion extension. MRI showed no significant difference in JZmax (16.0 mm[12.1-27.7] vs 15.5 mm [9.5-25.8], p = 0.81), JZdifference (9.5 mm[4.8-21.6] vs 8.4[3.8-19.5], p = 1) or Ratio JZ/myometrium (0.6 [0.5-0.8] vs. 0.6[0.4-0.8], p = 0.9) at baseline vs 6 month. Cystic lesions in the JZ were found in 9 women (50 %) before, and in 5 women (28 %) at 6 months, p = 0.13. CONCLUSION: TVU showed a significant decrease in JZ max and a reduced number of women with asymmetric myometrial wall thickness. The changes seen in this small pilot study may indicate that vaginal bromocriptine have an impact on adenomyosis that is reflected in radiological appearance.

16.
BMJ Open ; 10(8): e034179, 2020 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-32759237

RESUMO

OBJECTIVES: Chlamydia trachomatis is a public health problem. Widespread testing and re-testing after a sexually transmitted infection (STI) is recommended to contain the epidemic and has been adopted by many countries. A recent study in Stockholm found that serial testing was used as a substitute for condom use by youth presenting at the Youth Health Clinics (YHC). The objectives of this study are to explore frontline healthcare provider's perception of youth testing repeatedly for C. trachomatis as a substitute for condom use and their views on how this might be addressed. DESIGN: Qualitative study, in-depth interviews and analysed using content analysis. SETTING: YHC in Stockholm County, Sweden. PARTICIPANTS: Healthcare providers (HCPs) working at the YHC. FINDINGS: Testing used as a method of prevention of STIs by youth has been a well-known phenomenon observed by HCPs at the YHC. Despite frustration regarding this behaviour, attitudes towards youth visiting the clinics repeatedly were overall positive. It is seen as an opportunity to reach youth with primary prevention strategies. Time for in-depth conversations with the youth is considered essential to understand the various reasons behind sexual risk-taking and to tailor counselling accordingly. Introducing concepts of self-compassion and self-respect in relation to sex is thought of as an effective intervention to improve sexual health among youth. CONCLUSION: HCPs' views on testing repeatedly for C. trachomatis as means of prevention, range widely from seeing this as 'a positive strategy for C. trachomatis prevention' to 'a waste of healthcare resources'. There was a more unified view on how this should be addressed. Testing without having time to problematise sexual risk-taking was seen as meaningless. In depth, one-on-one counselling was deemed important. While scaling up accessibility to testing services, primary prevention strategies must not be neglected.

17.
Eur J Obstet Gynecol Reprod Biol ; 252: 330-335, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32653606

RESUMO

OBJECTIVE: Long-term treatment with progesterone receptor modulators (PRM) is associated with a distinct histological entity termed progesterone receptor modulator associated endometrial changes (PAEC). While accumulating evidence implies that these changes are benign and reversible after cessation of treatment, there are currently no data underpinning their development. Consequently, as a precaution, endometrial shedding is recommended after long-term PRM intake. Avoiding endometrial shedding after treatment with a PRM and prior to the start of a progestin treatment would be beneficial for women in reproductive age to avoid pregnancy and bleeding. However, the endometrial morphology with such a treatment regimen is unknown. The aim of this study was to delineate the endometrial morphology following continuous long-term treatment with the PRM mifepristone and subsequent placement of a levonorgestrel intrauterine system (LNG-IUS) without prior shedding of the endometrium. STUDY DESIGN: This study reports the secondary outcome from a double-blinded randomized controlled trial conducted at Karolinska University Hospital, Sweden, November 2009 to January 2015. Healthy women aged 18-43 years with regular menstrual cycles were included. Eligible women were randomized to receive either 50 mg of mifepristone (n = 29) or a comparator (n = 29), every other day for two months followed by insertion of an LNG-IUS 52 mg. Endometrial biopsies were obtained at baseline and three months after placement of the device. The samples were histologically assessed. The main outcome measure of this sub-study was the endometrial morphology including presence of PAEC three months after LNG-IUS insertion. RESULTS: Nine and eight paired biopsies from the mifepristone and comparator group, respectively, were included in the histological analysis. There were no differences in baseline characteristics between the groups and all baseline endometrial biopsies were physiological. Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator. A progestin effect on the endometrium was seen in all samples. CONCLUSIONS: Placement of an LNG-IUS immediately following two months' treatment with the PRM mifepristone, without any prior shedding of the endometrium, may represent a feasible approach in terms of endometrial safety. However, larger studies are needed to confirm our results.

18.
Contraception ; 102(6): 424-427, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32687911

RESUMO

OBJECTIVE: Long-acting reversible contraceptives (LARCs) such as subdermal implants and intrauterine devices are promoted and increasingly used worldwide. Hence, in the light of this we also need to ensure easy access to the reversibility, i.e. emphasise the R in LARC. Our overall aim is to develop a device to facilitate implant removals. We evaluated the safety and performance of the two initial field prototypes where the main outcome was percentage of successful fixations and secondary outcomes were percentage of successful removals without the use of additional tools, duration of the procedure, satisfaction and adverse events. STUDY DESIGN: We performed a feasibility study including 41 subjects. RESULTS: We estimated a fixation rate of 35/41 (85%) and an overall removal rate of 24/41 (59%). Further, we measured that the median time for removals was 80 s and that subjects and operators were satisfied with the procedure. We recorded adverse events such as bruising and superficial abrasions. CONCLUSIONS: The device demonstrated a successful fixation rate, however, the removal rate will need to be further improved. IMPLICATIONS: This feasibility study shows that the device has potential and further research is needed to modify and optimize the device.

19.
Eur J Obstet Gynecol Reprod Biol ; 252: 7-14, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32559602

RESUMO

OBJECTIVE: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. STUDY DESIGN: The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. RESULTS: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. CONCLUSION: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.

20.
Acta Obstet Gynecol Scand ; 99(12): 1611-1617, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32573767

RESUMO

INTRODUCTION: There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (3 minutes) was developed about EMA in three languages that summarized the EMA process for use in the UK, France and Sweden. MATERIAL AND METHODS: We conducted a multicenter randomized controlled trial to compare information on EMA delivered by an animated film vs a face-to-face consultation. Women requesting EMA (≤9 weeks' gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362. RESULTS: 172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between the animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P = .007) in favor of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA. CONCLUSIONS: A "short" audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardized and high-quality information to women seeking EMA.

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