Telemedicine medical abortion service in Georgia: an evaluation of a strategy with reduced number of in-Clinic visits.

PURPOSE: To evaluate feasibility and acceptability of a medical abortion service that offers: a telemedicine visit (in place of an in-person visit) during a mandatory waiting period, and at-home follow-up with the use of multi-level pregnancy tests (MLPT). METHODS: Participants were screened for eligibility in clinic, and during the waiting period, received a telephone call to confirm desire to proceed with the service. Participants were mailed a study package containing mifepristone, misoprostol, two multi-level pregnancy tests, and instructions for their use. Follow-up consultation took place by phone to evaluate abortion completeness. The analysis was descriptive. RESULTS: One-hundred twenty-two participants were enrolled in the study, and 120 chose to proceed with the abortion after the waiting period and were sent a study package. One participant was lost to follow up. The majority of participants did not experience problems receiving the study package (94.1%, n = 112), took mifepristone (100%, n = 119), misoprostol (99.2%, n = 118), and MLPTs (99.1%, n = 116) as instructed, and forwent additional clinic visits (91.6%, n = 109). All participants were satisfied with the service. Most participants had a complete abortion without a procedure (95.8%, n = 114). CONCLUSIONS: The adapted telemedicine medical abortion service was feasible and satisfactory to participants and has the potential to make medical abortion more patient-centered where waiting periods are mandated.

Very early medical abortion: treatment with mifepristone and misoprostol before ultrasonographic visualisation of an intrauterine pregnancy.

INTRODUCTION: Abortion providers may be reluctant to commence abortion before ultrasound evidence of intrauterine pregnancy (IUP) due to concerns of missed ectopic pregnancy. In 2017, very early medical abortion (VEMA) was introduced at an abortion service in Edinburgh, UK. Following ultrasound, patients without confirmed IUP, and without symptoms or risk factors for ectopic pregnancy, could commence treatment immediately after baseline serum-human chorionic gonadotrophin (hCG) measurement, and return for follow-up serum-hCG a week later to determine treatment success (≥80% decline from baseline). This study aimed to compare clinical outcomes between two pathways: (1) VEMA; and (2) standard-of-care delayed treatment where treatment is only commenced on IUP confirmation by serial serum-hCG monitoring and/or repeat ultrasound. METHODS: A retrospective database review was conducted of VEMA eligible patients from July 2017 to December 2021. Study groups were determined by patient preference. Records were searched for abortion outcomes, duration of care, number of appointments (clinic visits, ultrasounds, serum-hCG) and clinical data entries. RESULTS: Of 181 patients included, 77 (43%) chose VEMA and 104 (57%) chose delayed treatment. 11/181 (6.1%) were lost to follow-up. Cohort ectopic prevalence was 4.4% and was not statistically different between groups (2.6% vs 5.8%, VEMA vs delayed group, respectively, p=0.305), as with complete abortion rates (93.3% vs 97.6%, p=0.256). All VEMA group ectopics were detected on the seventh day (from initial visit) while time-to-diagnosis for delayed group ectopics ranged from 7 days to 3 weeks. VEMA patients had significantly reduced duration of care (12 vs 21 days, p<0.001), number of visits (2 vs 3, p<0.001), ultrasounds (1 vs 2, p<0.001) and data entries (6 vs 9, p<0.001). CONCLUSIONS: VEMA is safe, effective and reduces the duration of care, number of appointments and clinical administrative time. It should be offered to medically eligible patients.

Alternative Management of Cushing's Syndrome During Covid-19 Pandemic

Cushing's syndrome results from prolonged exposure to glucocorticoids. Surgery is often the first-line treatment for this condition, regardless of etiology. However, the COVID-19 pandemic caused a decrease in surgical procedures due to the risk of infection transmission. There are still emergency cases of Cushing's syndrome that are admitted to the hospital and require urgent management. The current treatment should be focused on medical management and endovascular embolization in selective cases. Embolization can be performed in facilities where there aretrained personnel with experience in adrenal embolization. Surgery, which traditionally is a first-line therapy, can increase the risk of infection, therefore, it should be avoided. The current review provides a brief description of the possible options for the management of adrenal Cushing's syndrome during the COVID-19 pandemic.Copyright © 2022 Bentham Science Publishers.

Mifepristone (RU-486®) as a Schedule IV Controlled Drug-Implications for a Misleading Drug Policy on Women's Health Care.

BACKGROUND: Mifepristone (RU-486) has been approved for abortion in Taiwan since 2000. Mifepristone was the first non-addictive medicine to be classified as a schedule IV controlled drug. As a case of the "misuse" of "misuse of drugs laws," the policy and consequences of mifepristone-assisted abortion for pregnant women could be compared with those of illicit drug use for drug addicts. METHODS: The rule-making process of mifepristone regulation was analyzed from various aspects of legitimacy, social stigma, women's human rights, and access to health care. RESULTS AND DISCUSSION: The restriction policy on mifepristone regulation in Taiwan has raised concerns over the legitimacy of listing a non-addictive substance as a controlled drug, which may produce stigma and negatively affect women's reproductive and privacy rights. Such a restriction policy and social stigma may lead to the unwillingness of pregnant women to utilize safe abortion services. Under the threat of the COVID-19 pandemic, the US FDA's action on mifepristone prescription and dispensing reminds us it is time to consider a change of policy. CONCLUSIONS: Listing mifepristone as a controlled drug could impede the acceptability and accessibility of safe mifepristone use and violates women's right to health care.

History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion.

This article examines the decades-long campaign to increase access to abortion pills in the United States, including advocates' work to win U.S. Food and Drug Administration approval of mifepristone and misoprostol for abortion, the continuing restrictions on mifepristone and the multiple strategies advocates have pursued to challenge these restrictions, including lobbying the FDA to remove the restrictions, obtaining a limited research exemption from FDA restrictions and suing the FDA during the COVID pandemic. The article pays particular attention to influence of research conducted on the safety and efficacy of medication abortion as well as research on the impact of increased availability of abortion pills through telemedicine during the pandemic. The article also addresses self-managed abortion, where people obtain and use mifepristone and/or misoprostol outside of the formal healthcare system, and documents the growing network of organizations providing logistical, medical and legal support for people self-managing abortion. The article concludes with reflections on the role abortion pills might play in the post-Roe era amid increasingly divergent abortion access trends across different regions of the United States.

Social inequalities in utilization of a feminist telehealth abortion service in Brazil: A multilevel analysis.

The disruption caused by the COVID-19 pandemic on health services around the world boosted interest over telehealth models of care. In Brazil, where abortion is heavily restricted, abortion seekers have long relied on international telehealth services to access abortion pills. We conducted a cross-sectional multilevel study to assess the effect of individual and contextual social factors on utilization of one such service. For the individual-level, we analyzed data from the records of abortion seekers contacting this feminist international telehealth organization during 2019 (n = 25,920). Individual-level variables were age, race, education level and pregnancy length. Contextual-level units were states, for which we used data from the national Demographic Census and Household Surveys. Contextual-level variables were household income per capita, adjusted net school attendance rate, percentage of racialized women and income Gini Index. We fitted five multilevel Poisson Mixed-effects models with robust variance to estimate prevalence ratios (PR) of service utilization, which was defined as receiving abortion pills through the service. We found that only 8.2% of requesters got abortion pills through the service. Utilization was higher among women who were older, white, more educated and 5-8-weeks pregnant. Independently of this, service utilization was higher in states with higher income and education access, with lower proportions of racialized women, and located in the South, Southeast and Central-West regions. We concluded that while feminist telehealth abortion initiatives provide a life-saving service for some abortion seekers, they are not fully equipped to overcome entrenched social inequalities in their utilization, both at individual and contextual levels.

What complications have arisen after early medical abortion -’both pills by post’’ policy in the uk during Covid? Do these increase the risk of subsequent premature birth?

BackgroundDuring 2019 NICE and the RCOG introduced UK guidelines normalising the early medical abortion (EMA) protocol for pregnancies prior to 10 weeks gestation. Mifepristone is taken at the abortion clinic, and the second pill, Misoprostol may be taken unsupervised at home 36–48 hours later. In March 2020, UK EMA policy changed, and telemedicine with ‘both pills by post’(BPBP) was authorised by DHSC, during Covid-19.MethodsA worldwide systematic review and meta-analyses were conducted to compare risk of PTB after one or more abortions compared to none, and PB after medical versus surgical abortion. Systematic evidence on outcomes after medical abortion are recorded through the Finnish Abortion registry. Mannisto (2013) published a paper showing that when surgical abortion, or evacuation of retained products of conception (ERPC) is required after a medical abortion, it increases the risk of subsequent PB by 241%. Very little data has been collected on this subject in England. We examine data from FOI requests to CQC in Dec 2020 and to NHS Acute hospital trust A&E departments in England and Wales (E&W) to investigate the incidence of complications (haemorrhage and sepsis) and ERPC after EMA and BPBP since April 2020.ResultsOur meta-analysis showed adj OR of 1.52, 95% CI (1.43–1.62), for increased risk of PTB after Abortion, compared to none. Surgical abortion carried more risk (RR 1.23) than Medical Abortion. FOI (response rate 67%) showed a 5.9% EMA failure rate in E&W from data from NHS A&E depts between April 2020 and 2021. This is similar to EMA failure rate (5.48%) published in Marie Stopes Australia 2020 report. It means that more than 7,400 women per annum across England have had complications from EMA since the Covid approval for telemedicine and BPBP. 2.4% needed a subsequent ERPC, which increases further the risk of a PTB in a later pregnancy. Incidence of complications or ERPC after EMA is 0.75%, 5x higher than reported by DHSC (0.15%).ConclusionThese results suggest that this policy of BPBP during Covid-19, should revert to in-person consultation for EMA for the safety of women. The BPBP was a departure from Evidence Based Medicine. Abortion should be appropriately governanced, and outcomes fully evaluated with evidence collected using longitudinal data via the NHS number on HSA4 forms. This would inform a safer policy for the wellbeing of women and help to reduce the increasing rates of PTB for the future.

Telemedicine Provision of Medication Abortion

The first documented use of telemedicine in US abortion care was in Iowa in 2008, where it was used to extend the reach of the small number of physicians willing to provide medication abortion there.1 Because of regulations imposed by the US Food and Drug Administration (FDA), patients still needed to come into a medical office to receive the mifepristone, used together with misoprostol. In the first 16 months of the service, 33% of medication abortions at a Planned Parenthood affiliate in Iowa were provided using telemedicine.1 This proportion increased overtime, and data from the affiliate spanning seven years after the service was introduced demonstrated that 46% of medication abortions were provided using telemedicine.2 Research on this modelof providing telemedicine found it to be safe and effective, with a high level of satisfaction among patients.1,2 In our previous article,3 we found that in the two years after the model was introdi iced, there was a small but significant decline in second-trimester abortion. Overall, our findings s ıggested that telemedicine improved access to medication abortion and to early abortion generally. Since our article was published, there has been a rapid expansion of the use of telemedicine in all aspects of medicine, including for abortion care.

Barriers to Telemedicine for First-Trimester Medical Abortion Provision in Canada in 2019

Objectives: In 2017, mifepristone became available for first trimester medical abortion (FTMA) in Canada. Shortly after, regulations permitted pharmacies to dispense mifepristone to patients, facilitating telemedicine provision. Our objective was to explore the barriers to providing FTMA using telemedicine in Canada in 2019. Methods: We conducted a cross-sectional, national, self-administered, anonymized survey of physicians and nurse practitioners who provided abortion care in Canada in 2019. Online invitations were sent through professional health organizations using a modified Dillman technique to optimize recruitment. Questions elicited provider demographics and perceived barriers to offering telemedicine FTMA. We used R software for descriptive statistics. Results: Four hundred sixty-five clinicians were included for analyses, of which 388 reported providing FTMA. Among those, 44.0% reported using telemedicine (for consultations, while often obtaining testing) for FTMA. British Columbia respondents reported the highest proportion of telemedicine use at 63.8%;the lowest was in Québec (10.7%). The majority of FTMA respondents (77.7%) reported barriers to telemedicine. The most common barriers were inability to confirm gestational age with ultrasound (43.0%), and lack of provincial fee code to pay practitioners (30.2%), timely access to serum hCG testing (24.6%), and nearby emergency services (23.3%). Few reported facility regulations (8.9%) and provincial regulations (4.9%) as barriers to providing telemedicine-based care;provincial regulation barriers were most common in Québec (16.1%). Conclusions: Less than half of respondents reported providing some abortion care via telemedicine and the majority perceived barriers. Low-test medical abortion protocols developed during COVID-19 have the potential to overcome some barriers. Keywords: telemedicine;abortion, induced;surveys and questionnaires;Canada;delivery of health care;mifepristone

Telemedicine, Medication Abortion, and Access After Roe v. Wade

FEDERAL RESTRICTIONS ON MEDICATION ABORTION Delivery of mifepristone for the medical termination of uterine pregnancy is subject to a Risk Evaluation and Mitigation Strategy (REMS) established by the US Food and Drug Administration (FDA). The American College of Obstetricians and Gynecologists opposes REMS for mifepristone, citing safety data from two decades of use, lack of benefit for patients, barriers they create for underserved and rural communities,3 and barriers for providers and clinics that decrease the number of clinicians providing this care.4 In December 2021, the FDA removed the in-person dispensing requirement and added a requirement for pharmacy certification. Furthermore, shorter travel distances are associated with significant reductions in times to appointments.6 Finally, data from a cohort study representing 85% of medication abortions performed between April and June 2020 indicated that a hybrid TMAB at-home model had a four-day shorter waiting time and an increased proportion of medication abortions provided at six weeks' gestation or earlier.7 In their study, Seymour et al. identified 1091 abortion providers and Planned Parenthood clinics in the United States, geocoded all facility locations, and calculated the proportion of women of reproductive age in every census tract who live within a 30-, 60-, or 90-minute drive to a participating clinic. A recent AJPH editorial added urgency to prior calls to define broadband Internet access (BIA) as a social determinant of health because it affects access to health care, economic stability, education, food, community and social context, and neighborhood and physical environment.8 Notably, most people of reproductive age reported having BIA.9 But access varies by age, race/ethnicity, rural residence, and other demographic characteristics.

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19.

BACKGROUND: The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks' gestation. AIMS: To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction-expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home. METHODS: We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction-expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment. RESULTS: Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24-72 hours between medications). The mean (SD) induction-expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation. CONCLUSION: Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.

Providing Mifepristone and Misoprostol in Emergency Departments During the COVID-19 Pandemic

INTRODUCTION: Compared to misoprostol alone, medical management of early pregnancy loss (EPL) with mifepristone and misoprostol has a 25% higher success rate, reduces subsequent uterine aspiration, and is cost-effective. During the COVID-19 pandemic, we began providing mifepristone and misoprostol for EPL in our urban emergency departments (EDs), aiming to increase access to essential services and to minimize repeated health care visits. We sought to describe the safety and efficacy of this novel practice. METHODS: With institutional review board approval, we retrospectively reviewed the charts of all patients receiving mifepristone and misoprostol for first trimester pregnancy management in our EDs between April 2020 and March 2021 (n=33). Effective treatment was defined as pregnancy resolution after a single treatment with mifepristone and misoprostol. Safety outcomes included need for additional management, emergent surgical interventions, and blood transfusion. Descriptive statistics and univariate analysis were performed. RESULTS: The prevalence of effective treatment was 70% (n=23). Among the 10 subjects (30%) requiring additional management, interventions were: one additional dose of misoprostol (n=4), uterine aspiration (n=4), methotrexate (n=1), and uterine artery embolization (n=1). Three interventions (30%) were emergent, and two of these patients also required transfusion. Demographic characteristics were not associated with effective treatment nor with safety outcomes. Twenty-eight subjects (84%) participated in follow-up, 17 via telemedicine and 11 in person. CONCLUSION: Providing mifepristone and misoprostol for EPL in the ED may be an effective method to increase health care access. Further research is needed to determine whether this population is truly at increased risk for serious complications.

American College of Obstetricians and Gynecologists 2022 Annual Clinical and Scientific Meeting

The proceedings contain 344 papers. The topics discussed include: estimating in vivo levonorgestrel release rate and exposure over eight years with levonorgestrel releasing intrauterine system 52 mg use with population pharmacokinetic approach;immediate vs routine postpartum intrauterine device placement after teen pregnancy: a cost-effectiveness analysis;examining the association of immediate postpartum long-acting reversible contraception payment carve-outs and postpartum LARC use in Medicaid;contraceptive congruence: a novel measure of contraceptive use that acknowledges pregnancy ambivalence;charm 2: a gender synchronized family planning intervention for couples in rural India, a cluster randomized trial;telehealth follow-up after medical management for early pregnancy loss;providing mifepristone and misoprostol in emergency departments during the COVID-19 pandemic;and medical students' knowledge of and attitudes towards oocyte cryopreservation.

Self-reported contraceptive use and satisfaction among women accessing telemedicine medical abortion at the onset of the COVID-19 pandemic at 3-6-month follow-up.

BACKGROUND: Changes in legislation due to COVID-19 led to the introduction of telemedicine for early medical abortion (EMA) at home in Scotland. The opportunity to provide contraception at presentation may be more limited with this model of care. We compared contraceptive use immediately post-abortion with 3-6 months later to determine if contraceptive needs were being met. METHODS: We contacted 579 women by telephone call or text message who agreed to be involved in a service evaluation of telemedicine EMA in NHS Lothian at 3-6 months post-abortion. A research nurse administered a questionnaire on the women's current contraception use. The research nurses also offered women support in switching or initiating contraception via the abortion service if desired. RESULTS: The response rate to the contact was 57% (331/579). Under a third of the women (30%, 98/331) were using the progestogen-only pill (POP) at 3-6 month follow-up, a significant decrease (p<0.00) compared with 65% (215/331) who were provided with POP at the time of abortion. Thirty-nine women (12%) were provided with contraception through this telephone contact, leading to a significant increase in the proportion using subdermal implants, the progestogen injectable or intrauterine contraception. CONCLUSIONS: This study shows that there was a decrease in the use of the POP 3-6 months after telemedicine EMA during the COVID-19 pandemic. Telephone contact at 3-6 months to facilitate obtaining contraception may be a promising strategy to improve access to effective methods with this model of abortion care.

"I just was really scared, because it's already such an uncertain time": Exploring women's abortion experiences during the COVID-19 pandemic in Canada.

OBJECTIVE: Travel restrictions, physical distancing and quarantine requirements, lockdowns, and stay-at-home orders due to COVID-19 have impacted abortion services across Canada. We aimed to explore the decision-making and care experiences of those who obtained abortion services during the COVID-19 pandemic and understand recent abortion patients' perspectives on demedicalized models of medication abortion service delivery. STUDY DESIGN: We conducted 23 semi-structured, in-depth interviews with women across Canada who obtained abortion care after March 15, 2020. We audio-recorded and transcribed the telephone/Skype/Zoom interviews and managed our data with ATLAS.ti. We analyzed the English-language interviews for content and themes using inductive and deductive techniques. RESULTS: The COVID-19 pandemic, and the associated economic and social support uncertainties, factored into many of our participants' decisions to obtain an abortion. Participants expressed relief and gratitude for being able to secure abortion care during the pandemic. Although women in our study reflected positively on their abortion care experiences, many felt that service delivery changes initiated because of the public health emergency exacerbated pre-COVID-19 barriers to care and contributed to feelings of loneliness and isolation. Our participants expressed considerable enthusiasm for demedicalized models of medication abortion care, including telemedicine services and behind-the-counter availability of mifepristone/misoprostol. CONCLUSIONS: For our participants, abortion care constituted an essential health service. Our findings demonstrate the importance of continuing to provide access to safe, effective, and timely abortion care during public health emergencies. Exploring additional models of demedicalized medication abortion service delivery to address persistent access barriers in Canada is warranted. IMPLICATIONS: Policymakers and clinicians should consider patient experiences as well as clinical evidence when considering regulatory changes to facilitate access to abortion care during public health emergencies. Identifying a multitude of ways to offer a full range of abortion services, including demedicalized models of medication abortion care, has the potential to meet significant needs in the COVID-19 era and beyond. The COVID pandemic highlights the need for demedicalized models, not only for the sake of those seeking abortion care but also to ease the burden on medical professionals during public health emergencies.

Utility of a routine ultrasound for detection of ectopic pregnancies among women requesting abortion: a retrospective review.

INTRODUCTION: Routine ultrasound may be used in abortion services to determine gestational age and confirm an intrauterine pregnancy. However, ultrasound adds complexity to care and results may be inconclusive, delaying abortion. We sought to determine the rate of ectopic pregnancy and the utility of routine ultrasound in its detection, in a community abortion service. METHODS: Retrospective case record review of women requesting abortion over a 5-year period (2015-2019) with an outcome of ectopic pregnancy or pregnancy of unknown location (PUL) at a service (Edinburgh, UK) conducting routine ultrasound on all women. Records were searched for symptoms at presentation, development of symptoms during clinical care, significant risk factors and routine ultrasound findings. RESULTS: Only 29/11 381 women (0.25%, 95% CI 0.18%, 0.33%) had an ectopic pregnancy or PUL (tubal=18, caesarean scar=1, heterotopic=1, PUL=9). Eleven (38%) cases had either symptoms at presentation (n=8) and/or significant risk factors for ectopic pregnancy (n=4). A further 12 women developed symptoms during their clinical care. Of the remaining six, three were PUL treated with methotrexate and three were ectopic (salpingectomy=2, methotrexate=1). In three cases, the baseline ultrasound indicated a probable early intrauterine pregnancy. CONCLUSIONS: Ectopic pregnancies are uncommon among women presenting for abortion. The value of routine ultrasound in excluding ectopic pregnancy in symptom-free women without significant risk factors is questionable as it may aid detection of some cases but may provide false reassurance that a pregnancy is intrauterine.