Deception by obfuscation: Studnicki et al.'s retracted longitudinal cohort study of emergency room utilization following abortion.

OBJECTIVES: In November 2022, the anti-abortion advocacy group Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication's safety record. Such challenges relied on a study examining the incidence of emergency room visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999-2015. In February 2024 that study was retracted by its publisher. In this paper, we analyzed the methods and presentations of the data used in the study. STUDY DESIGN: We drew upon commonly accepted principles in responsible epidemiologic and scientific research to evaluate the methods and presentations of the data and organized our findings into themes. RESULTS: We found multiple instances of methodological flaws, mischaracterizations, and obfuscations of data in this study, including use of a misleading research question and framing, analytic flaws, inappropriate use of an unvalidated proxy measure for outcomes of interest, and inappropriate and deceptive visualizations of data. In each instance, the resulting effect obfuscated and misrepresented the safety of medication abortion with mifepristone. CONCLUSIONS: The misrepresentation and exaggeration of data promoted and exacerbated misinterpretations about the study's findings, resulting in substantial harm before it was retracted. Recognizing that ongoing judicial proceedings threaten access to conventional reproductive health care in the United States, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations. IMPLICATIONS: Studnicki et al.'s study of emergency room visits after abortion misrepresented the safety of mifepristone with multiple instances of methodological flaws and obfuscations of data. While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion, which has an established safety record.

Retrospective cohort study comparing success of medical management of early pregnancy loss in pregnancies conceived with and without medical assistance.

OBJECTIVE: To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who conceived without medical assistance and those who conceived through in vitro fertilization (IVF), after fresh or frozen embryo transfer, and evaluate for the predictive factors of success, time to first passage of tissue, and time to complete resolution of pregnancy. DESIGN: Retrospective cohort study. SETTING: University hospital. PATIENT(S): Women who presented with EPL below 13 weeks of gestation between June 2013 and July 2021 who were managed medically with mifepristone 200 mg orally and misoprostol 800 mcg vaginally were included in the study. INTERVENTION(S): Medical management with mifepristone and misoprostol; conception without medical assistance vs. post-IVF, after fresh or frozen embryo transfer. MAIN OUTCOME MEASURE(S): We evaluated overall success and performed subgroup analysis according to the mode of conception and compared fresh vs. frozen-thawed embryo transfers for IVF pregnancies. In all groups, we also calculated success according to gestational age and compared the time to first passage of tissue. The potential predictive factors of treatment success were analyzed. The side effects and complications of treatment were recorded. RESULT(S): A total of 930 women were included in the study, 99 (11%) of whom achieved pregnancy after IVF. The overall success of medical treatment was 89% with no statistically significant difference according to the mode of conception (89% vs. 89%) or type of transfer (fresh 89% vs. frozen 89%). Only lower gestational age by sonography was independently predictive of treatment success, showing a negative regression coefficient of ß = -0.333 and an odds ratio of 0.717. The mean time to first passage of tissue was 5.0 ± 2.1 hours. Altogether, 666 women (72%) showed pregnancy resolution on the day of medication administration, an additional 110 women at 1-week follow-up, and a further 74 women after ≥4 weeks on ultrasound. CONCLUSION(S): Medical management of EPL with mifepristone and misoprostol is a highly successful treatment option that results in completed abortion in a timely fashion in both pregnancies conceived without medical assistance and those conceived after IVF.

Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.

BACKGROUND: Clinical trials have established the high effectiveness and safety of medication abortion in clinical settings. However, barriers to clinical abortion care have shifted most medication abortion use to out-of-clinic settings, especially in the context of the COVID-19 pandemic. Given this shift, we aimed to estimate the effectiveness of self-managed medication abortion (medication abortion without clinical support), and to compare it to effectiveness of clinician-managed medication abortion. METHODS: For this prospective, observational cohort study, we recruited callers from two safe abortion accompaniment groups in Argentina and Nigeria who requested information on self-managed medication abortion. Before using one of two medication regimens (misoprostol alone or in combination with mifepristone), participants completed a baseline survey, and then two follow-up phone surveys at 1 week and 3 weeks after taking pills. The primary outcome was the proportion of participants reporting a complete abortion without surgical intervention. Legal restrictions precluded enrolment of a concurrent clinical control group; thus, a non-inferiority analysis compared abortion completion among those in our self-managed medication abortion cohort with abortion completion reported in historical clinical trials using the same medication regimens, restricted to participants with pregnancies of less than 9 weeks' gestation. This study was registered with ISCRTN, ISRCTN95769543. FINDINGS: Between July 31, 2019, and April 27, 2020, we enrolled 1051 participants. We analysed abortion outcomes for 961 participants, with an additional 47 participants reached after the study period. Most pregnancies were less than 12 weeks' duration. Participants in follow-up self-managed their abortions using misoprostol alone (593 participants) or the combined regimen of misoprostol plus mifepristone (356 participants). At last follow-up, 586 (99%) misoprostol alone users and 334 (94%) combined regimen users had a complete abortion without surgical intervention. For those with pregnancies of less than 9 weeks' gestation, both regimens were non-inferior to medication abortion effectiveness in clinical settings. INTERPRETATION: Findings from this prospective cohort study show that self-managed medication abortion with accompaniment group support is highly effective and, for those with pregnancies of less than 9 weeks' gestation, non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting. These findings support the use of remote self-managed models of early abortion care, as well as telemedicine, as is being considered in several countries because of the COVID-19 pandemic. FUNDING: David and Lucile Packard Foundation. TRANSLATIONS: For the Arabic, French, Bahasa Indonesian, Spanish and Yoruba translations of the Article see Supplementary Materials section.

Abordaje integral de la Interrupción Voluntaria del Embarazo: (segunda entrega) / Comprehensive approach to the voluntary interruption of pregnancy: (second issue)

La legalización de la interrupción voluntaria del embarazo ha transformado la práctica médica con respecto a la atención de las pacientes que desean interrumpir la gestación hasta la semana 14 en Argentina. En la primera entrega, el equipo PROFAM compartió su punto de vista a través de una adaptación de su material educativo destinado, sobre todo, a aclarar los aspectos legales que hacen a la práctica cotidiana. En esta entrega se desarrolla en detalle el procedimiento para realizar un aborto farmacológico con misoprostol y mifepristona, así como las generalidades del aspirado manual endouterino. (AU)

The legalization of voluntary termination of pregnancy has transformed medical practice regarding the care of patients who wish to terminate a pregnancy up to 14 weeks in Argentina. In the first issue, the PROFAM team shared its point of view through an adaptation of its educational material aimed, above all, at clarifying the legal aspects of daily practice. In this issue, the procedure to perform a pharmacological abortion with misoprostol and mifepristone is developed in detail, as well as the generalities of manual uterine aspiration technique. (AU)

Network meta-analysis of 6 kinds of Chinese patent medicines combined with mifepristone in the treatment of uterine fibroids: A protocol for systematic review and network meta-analysis.

BACKGROUND: Uterine fibroids are benign. They belong to the category of "abdominal mass" in traditional Chinese medicine, and pathogenesis is mainly caused by weakness of the body, qi stagnation, and blood stasis. Drug therapy is the preferred treatment of uterine fibroids in clinical practice, and mifepristone is the most commonly used drug. In the past decade, a large number of clinical randomized controlled trials have proven that Chinese patent medicine combined with mifepristone in the treatment of uterine fibroids has a better curative effect, fewer adverse reactions, and higher safety than mifepristone alone. However, there is a lack of evidence-based research. This study aims to integrate clinical data through network meta-analysis to provide more evidence-based medical evidence for clinical medication. METHODS: The comprehensive search included Chinese and other-language databases, such as MEDLINE (PubMed), Web of Science, The Cochrane Library, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, China Scientific Journal Database, and China Biomedical Literature Database. Clinical randomized controlled trials of 6 Chinese patent medicines combined with mifepristone for the treatment of uterine fibroids, including Guizhi Fuling Capsule, Gongliuxiao Capsule, Gongliuqing Capsule, Danbie Capsule, Gongliuning Capsule, and Xiaojiean Capsule were retrieved. The search period was from January 2010 to April 2021. Two researchers screened the literature through EndNote and used Excel to extract data. RevMan 5.3 was used to evaluate the quality of the literature. Treatment measures were analyzed in R language, and a forest map and probability ranking map of various interventions were drawn. The network evidence map and correction comparison funnel map of various interventions were drawn by STATA 14.0 software. RESULTS: This study provides the clinical efficacy and safety of network meta-analysis of 6 kinds of Chinese patent medicines combined with mifepristone in the treatment of uterine fibroids will be systematically evaluated or descriptively analyzed. CONCLUSION: This study's purpose is to provide a reference for the clinical treatment of uterine fibroids to choose more effective intervention therapies.

The efficacy and safety of Xuefu Zhuyu Decoction combined with Mifepristone in the treatment of uterine leiomyoma: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Uterine leiomyoma (UL) is a common severe gynecological issue. In China, Xuefu Zhuyu Decoction (XFZYD), combined with Mifepristone, is widely used in the treatment of UL. However, their combined effectiveness and safety for this purpose have not yet been explored. AIM OF THE STUDY: This systematic review aims to evaluate the effectiveness and safety of XFZYD combined with Mifepristone as a method of treatment for UL. MATERIALS AND METHODS: We searched the following 7 databases: 3 English medical databases (PubMed, EMBASE, Cochrane Library), and 4 Chinese medical databases (Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and the Wanfang database). The primary outcome was the effect of XFZYD combined with Mifepristone on the effective rate, uterine leiomyoma volume (ULV), and uterine volume (UV) of uterine leiomyoma. Bias risk was assessed using the Cochrane risk of bias tool. The software RevMan5 was used to evaluate the quality of the included studies and process the data. RESULTS: The 11 studies included in this systematic review were all undertaken in China, with a total of 902 participants. The meta-analysis of XFZYD combined with Mifepristone compared with Mifepristone alone showed that the effective rate (RR 1.20, 95% confidence interval (CI): 1.14-1.27, P < 0.00001), ULV (SMD -1.60, 95% CI: 2.11 to -1.08, P < 0.00001), and UV (SMD -1.65, 95% CI: 1.85 to -1.44, P < 0.00001) in the primary outcomes, and estradiol (E2) (MD -51.81, 95% CI: 69.68 to -33.94, P < 0.00001), luteinizing hormone (LH) (MD -3.09, 95% CI: 3.58 to -2.60, P < 0.00001), follicle stimulating hormone (FSH) (MD -1.09, 95% CI: 1.86 to -0.31, P = 0.006), progesterone (P) (MD -3.55, 95% CI: 4.54 to -2.55, P < 0.00001), and adverse events (RR 0.55, 95% CI: 0.34-0.89), P = 0.01) in the secondary outcomes were significantly reduced, and the data were statistically significant. The subgroups of ULV, E2, and FSH showed that the treatment time might not have been the heterogeneous source of ULV and FSH, but was the heterogeneous source of E2. Sensitivity analysis was carried out on the 3 outcome indicators, and the results were relatively stable after excluding one reference for each indicator. CONCLUSION: There is some encouraging evidence that the combination of XFZYD and Mifepristone can benefit patients by treating UL. However, because of research shortcomings such as lacking allocation concealment and blindness, this study's results should be treated with caution. In order to verify the advantages of this method, it is necessary to carry out further large-scale randomized controlled trials.

Pharmacist dispensing of the abortion pill in Canada: Diffusion of Innovation meets integrated knowledge translation.

BACKGROUND: Since Canadian drug regulatory approval of mifepristone for medical abortion in 2015 and its market availability in January 2017, the role of pharmacists in abortion provision has changed rapidly. We sought to identify the factors that influenced the initiation and provision of medical abortion from the perspectives of Canadian pharmacists, bridging two frameworks - Diffusion of Innovation in Health Service Organizations and integrated knowledge translation. METHODS: We conducted one-on-one semi-structured interviews with pharmacists residing in Canada who intended to stock and dispense mifepristone within the first year of availability. Our data collection, analysis, and interpretation were guided by reflexive thematic analysis and supported by an integrated knowledge translation partnership with pharmacy stakeholders. RESULTS: We completed interviews with 24 participants from across Canada: 33% had stocked and 21% had dispensed mifepristone. We found that pharmacists were willing and able to integrate medical abortion care into their practice and that those who had initiated practice were satisfied with their dispensing experience. Our analysis indicated that several key Diffusion of Innovation constructs impacted the uptake of mifepristone, including: innovation (relative advantage, complexity and compatibility, technical support), system readiness (innovation-system fit, dedicated time, resources), diffusion and dissemination (expert opinion, boundary spanners, champions, social networks, peer opinions), implementation (external collaboration), and linkage. Participants' experiences suggest that integrated knowledge translation facilitated evidence-based changes to mifepristone dispensing restrictions, and communication of those changes to front line pharmacists. CONCLUSIONS: We illustrate how Diffusion of Innovation and integrated knowledge translation may work together as complimentary frameworks for implementation science research. Unlike in the USA, UK, and other highly regulated settings globally, pharmacists in Canada are permitted to dispense mifepristone for medical abortion. We contribute to literature that shows that mifepristone dispensed outside of hospitals, clinics, and medical offices is safe and acceptable to both patients and prescribers. This finding is of particular importance to the current COVID-19 pandemic response and calls for continued and equitable access to abortion care in primary practice.

Women's experiences of a telemedicine abortion service (up to 12 weeks) implemented during the coronavirus (COVID-19) pandemic: a qualitative evaluation.

OBJECTIVE: To explore the experiences of women in Scotland who accessed medical abortion at home up to 12 weeks' gestation, delivered via a telemedicine abortion service implemented in response to the coronavirus (COVID-19) pandemic, to identify areas for improvement and inform service provision. DESIGN: Qualitative interview study. SETTING: Abortion service in one National Health Service health board in Scotland. POPULATION OR SAMPLE: Twenty women who accessed telemedicine abortion services and self-administered mifepristone and misoprostol at home up to 12 weeks' gestation. METHODS: Thematic analysis of semi-structured qualitative interviews, informed by the Framework analytic approach. MAIN OUTCOME MEASURES: Women's experiences of accessing telemedicine for medical abortion at home, specifically: acceptability of the telephone consultation and remote support; views on no pre-abortion ultrasound scan; and self-administration of abortion medications at home. RESULTS: Novel study findings were three-fold: (1) participants valued the option of accessing abortion care via telemedicine and emphasised the benefits of providing a choice of telephone and in-person consultation to suit those with different life circumstances; (2) the quality of abortion care was enhanced by the telemedicine service in relation to access, comfort and flexibility, and ongoing telephone support; (3) participants described being comfortable with, and in some cases a preference for, not having an ultrasound scan. CONCLUSIONS: This research demonstrates support for the continuation of telemedicine abortion services beyond the temporary arrangements in place during COVID-19, and lends weight to the argument that offering the option of telemedicine abortion care can enable women to access this essential health service. TWEETABLE ABSTRACT: #Telemedicine provision of medical #abortion at home up to 12 weeks' gestation is acceptable and highly valued by #women #Research #SRHR @nbw80 @doctorjjrw @jeniharden @cameronsharon @mrc_crh @edinuniusher.

Methods for managing miscarriage: a network meta-analysis.

BACKGROUND: Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime. An estimated 15% of pregnancies end in miscarriage. Miscarriage can lead to serious morbidity, including haemorrhage, infection, and even death, particularly in settings without adequate healthcare provision. Early miscarriages occur during the first 14 weeks of pregnancy, and can be managed expectantly, medically or surgically. However, there is uncertainty about the relative effectiveness and risks of each option. OBJECTIVES: To estimate the relative effectiveness and safety profiles for the different management methods for early miscarriage, and to provide rankings of the available methods according to their effectiveness, safety, and side-effect profile using a network meta-analysis. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth's Trials Register (9 February 2021), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (12 February 2021), and reference lists of retrieved studies. SELECTION CRITERIA: We included all randomised controlled trials assessing the effectiveness or safety of methods for miscarriage management. Early miscarriage was defined as less than or equal to 14 weeks of gestation, and included missed and incomplete miscarriage. Management of late miscarriages after 14 weeks of gestation (often referred to as intrauterine fetal deaths) was not eligible for inclusion in the review. Cluster- and quasi-randomised trials were eligible for inclusion. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved. We excluded non-randomised trials. DATA COLLECTION AND ANALYSIS: At least three review authors independently assessed the trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for the primary outcomes of complete miscarriage and composite outcome of death or serious complications. The certainty of evidence was assessed using GRADE. Relative effects for the primary outcomes are reported subgrouped by the type of miscarriage (incomplete and missed miscarriage). We also performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available methods. MAIN RESULTS: Our network meta-analysis included 78 randomised trials involving 17,795 women from 37 countries. Most trials (71/78) were conducted in hospital settings and included women with missed or incomplete miscarriage. Across 158 trial arms, the following methods were used: 51 trial arms (33%) used misoprostol; 50 (32%) used suction aspiration; 26 (16%) used expectant management or placebo; 17 (11%) used dilatation and curettage; 11 (6%) used mifepristone plus misoprostol; and three (2%) used suction aspiration plus cervical preparation. Of these 78 studies, 71 (90%) contributed data in a usable form for meta-analysis. Complete miscarriage Based on the relative effects from the network meta-analysis of 59 trials (12,591 women), we found that five methods may be more effective than expectant management or placebo for achieving a complete miscarriage: · suction aspiration after cervical preparation (risk ratio (RR) 2.12, 95% confidence interval (CI) 1.41 to 3.20, low-certainty evidence), · dilatation and curettage (RR 1.49, 95% CI 1.26 to 1.75, low-certainty evidence), · suction aspiration (RR 1.44, 95% CI 1.29 to 1.62, low-certainty evidence), · mifepristone plus misoprostol (RR 1.42, 95% CI 1.22 to 1.66, moderate-certainty evidence), · misoprostol (RR 1.30, 95% CI 1.16 to 1.46, low-certainty evidence). The highest ranked surgical method was suction aspiration after cervical preparation. The highest ranked non-surgical treatment was mifepristone plus misoprostol. All surgical methods were ranked higher than medical methods, which in turn ranked above expectant management or placebo. Composite outcome of death and serious complications Based on the relative effects from the network meta-analysis of 35 trials (8161 women), we found that four methods with available data were compatible with a wide range of treatment effects compared with expectant management or placebo: · dilatation and curettage (RR 0.43, 95% CI 0.17 to 1.06, low-certainty evidence), · suction aspiration (RR 0.55, 95% CI 0.23 to 1.32, low-certainty evidence), · misoprostol (RR 0.50, 95% CI 0.22 to 1.15, low-certainty evidence), · mifepristone plus misoprostol (RR 0.76, 95% CI 0.31 to 1.84, low-certainty evidence). Importantly, no deaths were reported in these studies, thus this composite outcome was entirely composed of serious complications, including blood transfusions, uterine perforations, hysterectomies, and intensive care unit admissions. Expectant management and placebo ranked the lowest when compared with alternative treatment interventions. Subgroup analyses by type of miscarriage (missed or incomplete) agreed with the overall analysis in that surgical methods were the most effective treatment, followed by medical methods and then expectant management or placebo, but there are possible subgroup differences in the effectiveness of the available methods.  AUTHORS' CONCLUSIONS: Based on relative effects from the network meta-analysis, all surgical and medical methods for managing a miscarriage may be more effective than expectant management or placebo. Surgical methods were ranked highest for managing a miscarriage, followed by medical methods, which in turn ranked above expectant management or placebo. Expectant management or placebo had the highest chance of serious complications, including the need for unplanned or emergency surgery. A subgroup analysis showed that surgical and medical methods may be more beneficial in women with missed miscarriage compared to women with incomplete miscarriage. Since type of miscarriage (missed and incomplete) appears to be a source of inconsistency and heterogeneity within these data, we acknowledge that the main network meta-analysis may be unreliable. However, we plan to explore this further in future updates and consider the primary analysis as separate networks for missed and incomplete miscarriage.

Factors Associated With Use of an Online Telemedicine Service to Access Self-managed Medical Abortion in the US.

Importance: People in the US have been seeking self-managed abortions outside the formal health care system using medications obtained through online telemedicine. However, little is known about this practice, including potential motivating factors. Objective: To examine individual reasons for accessing medication abortion through an online telemedicine service as well as associations between state- and county-level factors and the rate of requests. Design, Setting, and Participants: This population-based cross-sectional study examined all requests for self-managed medication abortion through an online consultation form available from Aid Access, a telemedicine service in the US, between March 20, 2018, and March 20, 2020. Main Outcomes and Measures: Individual-level reasons for accessing the telemedicine service were examined as well as the rate of requests per 100 000 women of reproductive age by state. Zip code data provided by individuals making requests were used to examine county-level factors hypothesized to be associated with increased demand for self-managed abortion: distance to a clinic (calculated using location data for US abortion clinics) and the population proportion identifying as a member of a racial/ethnic minority group, living below the federal poverty level, and having broadband internet access (calculated using census data). Results: During the 2-year study period, 57 506 individuals in 2458 counties in 50 states requested self-managed medication abortion; 52.1% were aged 20 to 29 years (mean [SD] age, 25.9 [6.7] years), 50.0% had children, and 99.9% were 10 weeks' pregnant or less. The most common reasons cited by individuals making requests were the inability to afford in-clinic care (73.5%), privacy (49.3%), and clinic distance (40.4%). States with the highest rate of requests were Louisiana (202.7 per 100 000 women) and Mississippi (199.9 per 100 000 women). At the county level, an increase of 1 SD (47 miles) in distance to the nearest clinic was significantly associated with a 41% increase in requests (incidence rate ratio, 1.41; 95% CI, 1.31-1.51; P < .001), and a 10% increase in the population living below the federal poverty level was significantly associated with a 20% increase in requests (incidence rate ratio, 1.20; 95% CI, 1.13-1.28; P < .001). Conclusions and Relevance: In this cross-sectional study, clinic access barriers were the most commonly cited reason for requesting self-managed medication abortion using an online telemedicine service. At the county level, distance to an abortion clinic and living below the federal poverty level were associated with a higher rate of requests. State and federal legislation could address these access barriers.

Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso trial.

OBJECTIVE: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING: Twenty-eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). RESULTS: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.

Palliative Benefits of Oral Mifepristone for the Treatment of Metastatic Fibroblastic Osteosarcoma.

BACKGROUND/AIM: It has been hypothesized that many, or even most cancers, utilize a unique immunomodulatory protein, called the progesterone induced blocking factor (PIBF) to allow spread of the cancer. Support for this concept has been provided by cancer cell line studies showing that PIBF is produced by these cancer cells and mifepristone suppresses this protein and inhibits proliferation of these cells. Furthermore, controlled murine studies with several spontaneous different types of cancer showed a clear beneficial effect of mifepristone over placebo control. Finally, there have been a variety of anecdotal reports showing efficacy of mifepristone in providing increased length and quality of life in patients with different types of advanced cancers. CASE REPORT: Single agent mifepristone was found to provide significant palliative benefit for a 51-year-old male whose metastatic advanced fibroblastic osteosarcoma progressed despite surgery, radiotherapy, multiagent chemotherapy, and targeted therapy. CONCLUSION: Thus, osteosarcoma can be added to the list of cancers, not necessarily associated with the classic nuclear progesterone receptor, that seem to respond to progesterone receptor antagonist therapy.

Abortion exceptionalism and the mifepristone REMS.

Since its initial approval, mifepristone has been regulated with a strictness out of proportion to its risks. This paper explores how the regulation of mifepristone, specifically the Risk Evaluation and Mitigation Strategies (REMS) requirements, are a manifestation of abortion exceptionalism-the phenomenon of abortion being treated differently under the law than other comparable health care. The weight of medical and public health evidence demonstrates that mifepristone is extremely safe and the REMS are unnecessary. In fact, the mifepristone REMS is neither justified by the absolute risk of the medication itself, nor comprehensible as a logical response to the risks actually posed by mifepristone. Nevertheless, the REMS remain in place. From July 2020 through January 2021, enforcement of the REMS elements requiring in-person distribution of mifepristone were enjoined by court order due the COVID-19 pandemic. In other words, COVID-19 created a context so exceptional as to temporarily outweigh abortion exceptionalism. However, the reprieve did not last-in January 2021, the Supreme Court ruled to dissolve the injunction, allowing FDA to resume enforcement of the in-person requirements. In response, advocates called on the incoming Biden administration to direct FDA to suspend enforcement once more. This regulatory whiplash is itself further evidence that the REMS flow from political, rather than scientific, concerns. Abortion exceptionalism is apparent in the specific requirements of the REMS, and it is also apparent in the precarity of the regulatory scheme itself.

Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion.

Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days' gestation and for medication abortion up to 77 days' gestation. Gestational age is determined using ultrasonography or menstrual history. Ultrasonography is needed when gestational dating cannot be confirmed using clinical data alone or when there are risk factors for ectopic pregnancy. The most effective regimens for medication management of early pregnancy loss and medication abortion include 200 mg of oral mifepristone (a progesterone receptor antagonist) followed by 800 mcg of misoprostol (a prostaglandin E1 analogue) administered buccally or vaginally. Cramping and bleeding are expected effects of the medications, with bleeding lasting an average of nine to 16 days. The adverse effects of misoprostol (e.g., low-grade fever, gastrointestinal symptoms) can be managed with nonsteroidal anti-inflammatory drugs or antiemetics. Ongoing pregnancy, infection, hemorrhage, undiagnosed ectopic pregnancy, and the need for unplanned uterine aspiration are rare complications. Clinical history, combined with serial quantitative beta human chorionic gonadotropin levels, urine pregnancy testing, or ultrasonography, is used to establish complete passage of the pregnancy tissue.

Comparison of surgical versus medical termination of pregnancy between 13-20 weeks of gestation in Ethiopia: A quasi-experimental study.

BACKGROUND: Dilation and evacuation is a method of second trimester pregnancy termination introduced recently in Ethiopia. However, little is known about the safety and effectiveness of this method in an Ethiopian setting. Therefore, the study is intended to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion between 13-20 weeks' gestational age. METHODS: This is a quasi-experimental study of women receiving second trimester termination of pregnancy between 13-20 weeks. Patients were allocated to either medical or surgical abortion based on their preference. A structured questionnaire was used to collect demographic information and clinical data upon admission. Procedure related information was collected after the procedure was completed and before the patient was discharged. Additionally, women were contacted 2 weeks after the procedure to evaluate for post-procedural complications. The primary outcome of the study was a composite complication rate. Data were collected using Open Data Kit and then analyzed using Stata version 14.2. Univariate analyses were performed using means (standard deviation), or medians (interquartile range) when the distribution was not normal. Multiple logistic regression was also performed to control for confounders. RESULTS: Two hundred nineteen women chose medical abortion and 60 chose surgical abortion. The composite complication rate is not significantly different among medical and surgical abortion patients (15% versus 10%; p = 0.52). Nine patients (4.1%) in the medical arm required additional intervention to complete the abortion, while none of the surgical abortion patients required additional intervention. Median (IQR) hospital stay was significantly longer in the medical group at 24 (12-24) hours versus 6(4-6) hours in the surgical group p<0.001. CONCLUSION: From the current study findings, we concluded that there is no difference in safety between surgical and medical methods of abortion. This study demonstrates that surgical abortion can be used as a safe and effective alternative to medical abortion and should be offered equivalently with medical abortion, per the patient's preference.

Second trimester medical abortion in a primigravida with lupus nephritis and rapidly progressive renal failure: challenges and outcome.

In the second trimester, medical abortion is preferred as it is less invasive, and the surgical method carries more risk. There is a paucity of published literature on medical abortion in women with renal failure requiring haemodialysis. We came across a woman who presented with rapidly progressive renal failure at 18 weeks of gestation and required therapeutic abortion. We are reporting the challenges, outcomes, and precautions to be taken while performing a medical abortion in such a case.

Modulation of heroin intake by ovarian hormones in gonadectomized and intact female rats.

RATIONALE: Heroin intake decreases during the proestrus phase of the estrous cycle in female rats. Circulating concentrations of both estradiol and progesterone peak during proestrus, and it is not known which of these hormones, or their combination, are responsible for these effects. OBJECTIVES: The purpose of this study was to determine the effects of estradiol, progesterone, and their combination on heroin self-administration in female rats. METHODS: In Experiment 1, the estrous cycle of intact female rats was tracked daily. If a rat was in proestrus, either the estrogen receptor antagonist, raloxifene, the progesterone receptor antagonist, mifepristone, or their combination was administered 30 min prior to a heroin self-administration session. In Experiment 2, separate groups of ovariectomized female rats were treated chronically with exogenous estradiol, progesterone, estradiol + progesterone, or vehicle, and heroin intake was examined over a 100-fold dose range. RESULTS: In Experiment 1, raloxifene, but not mifepristone, significantly blocked proestrus-associated decreases in heroin intake. In Experiment 2, estrogentreated rats self-administered less heroin than any other group and significantly less heroin than rats treated with progesterone. CONCLUSIONS: These data suggest that (1) estradiol but not progesterone is responsible for proestrus-associated decreases in heroin intake and (2) estradiol decreases heroin intake relative to progesterone. These data differ from those reported previously with stimulants and suggest that estrogen-based pharmacotherapies may be of value to women with opioid use disorder.