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.

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.

Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis.

OBJECTIVE: To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage. METHODS: Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial. RESULTS: In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in-operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35-191.07) and $217.85 (99% CI 217.19-218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased. CONCLUSION: Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.

"We've got rights and yet we don't have access": Exploring patient experiences accessing medication abortion in Australia.

OBJECTIVES: Across Australia, multiple strategies have emerged to decentralize abortion care and increase access to mifepristone, including incorporating medication abortion into primary care and offering the mifepristone and misoprostol regimen via telemedicine. We aimed to explore the experiences of patients accessing medication abortion care across these different health service delivery formats and different geographic areas. STUDY DESIGN: We conducted in-depth interviews with 22 people from across Australia who had used mifepristone for abortion. We audio-recorded and transcribed all interviews and managed our data with ATLAS.ti. We used deductive and inductive techniques to analyze these data for content and themes. RESULTS: Although participants were generally satisfied with the abortion care they received, many described medication abortion care in Australia as inaccessible and confusing to find. Our participants incurred variable and often significant financial costs when obtaining their abortion and many reported that their interactions with general practitioners when trying to locate an abortion provider were uninformative and stigmatizing. Participants were enthusiastic about obtaining medication abortion through a variety of service delivery modalities, including telemedicine, and believed these strategies could increase equitable and affordable access. CONCLUSIONS: Barriers to finding and accessing abortion care persist across Australia. Efforts to challenge the over-regulation of mifepristone, increase the affordability of medication abortion, and enhance training opportunities to educate a variety of clinicians about medication abortion and support provision from a range of providers appear warranted. IMPLICATIONS: The continued over regulation of mifepristone creates barriers for incorporating medication abortion into primary care settings and has significant implications for patient access and abortion stigma. Regulatory reform and provider education and training have the potential to improve abortion patients' experiences with medication abortion.

Barriers and Facilitators to the Implementation of First Trimester Medical Abortion With Mifepristone in the Province of Québec: A Qualitative Investigation.

OBJECTIVE: Mifepristone became available in Canada in January 2017, but provincial medical policy delayed its use for medical abortion (MA) in Québec for 1 year. The objective of this study was to identify barriers and facilitators experienced by physicians who could potentially provide this newer abortion practice in Québec. METHODS: This study was part of the Canadian Contraception and Abortion Research Team-Mifepristone Implementation Study, an observational, prospective, mixed-methods study. Interviews were conducted with physicians representing all health regions of Québec. Using thematic analysis guided by diffusion of innovation theory, the study identified key barriers and facilitators to implementation. RESULTS: From January 2017 to March 2018, study investigators interviewed 25 family physicians and 12 obstetrician-gynaecologists. Most were women (81%), over 40 years old (65%), with >20 years in practice since residency (49%). Less than half of the sample provided abortion services (41%), and only 8% provided MA with mifepristone. Key barriers to implementation were: (1) uncertainty or confusion about policies regarding MA, (2) lack of human resources or support from colleagues, (3) uncertainty about product distribution, (4) confusion about professional collaboration, and (5) lack of local infrastructure. Key facilitators were: (1) perception of support and influence from colleagues, (2) previous experience with provision of first trimester MA, (3) requests for first trimester MA by patients or other physicians, and (4) knowledge of research on mifepristone MA. CONCLUSION: Despite Health Canada's approval of mifepristone in Canada and supportive federal policies for provision of MA in primary care, physicians in the province of Québec face onerous barriers to the practice of mifepristone MA.

Online access to abortion medications: a review of utilization and clinical outcomes.

We performed a search in PubMed and Web of Science on the self-use of abortion medication after online access. Studies published between January 1, 1995, and March 31, 2019, were considered. We included studies of online services that were (i) led by healthcare staff (n = 14), (ii) led by non-healthcare staff (n = 4), and (iii) providing noninteractive access (n = 17). Our outcomes were utilization (frequency and demand for services), acceptability for women, safety, and success rate. Key findings: Women are increasingly using the Internet to access abortion medication. Available services are of varying quality. Women accessing noninteractive services report feelings of distress related to the lack of medical guidance, and the demand for interactive guidance through the abortion process is high. Women using services led by healthcare staff report high rates of satisfaction and similar rates of clinical outcomes as those of in-person abortion care.

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: study protocol for a randomized double blinded placebo-controlled comparison (Triple M Trial).

BACKGROUND: Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to remove the products of conception from the uterus. Curettage, although highly effective, is associated with a risk of complications; medical treatment with misoprostol is a safe and less expensive alternative. Unfortunately, after 1 week of expectant management in case of EPF, medical treatment with misoprostol has a complete evacuation rate of approximately 50%. Misoprostol treatment results may be improved by pre-treatment with mifepristone; its effectiveness has already been proven for other indications of pregnancy termination. This study will test the hypothesis that, in EPF, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). METHODS: The trial will be performed multi-centred, prospectively, two-armed, randomised, double-blinded and placebo-controlled. Women with confirmed EPF by ultrasonography (6-14 weeks), managed expectantly for at least 1 week, can be included and randomised to pre-treatment with oral mifepristone (600 mg) or oral placebo (identical in appearance). Randomisation will take place after receiving written consent to participate. In both arms pre-treatment will be followed by oral misoprostol, which will start 36-48 h later consisting of two doses 400 µg (4 hrs apart), repeated after 24 h if no tissue is lost. Four hundred sixty-four women will be randomised in a 1:1 ratio, stratified by centre. Ultrasonography 2 weeks after treatment will determine short term treatment effect. When the gestational sac is expulsed, expectant management is advised until 6 weeks after treatment when the definitive primary endpoint, complete or incomplete evacuation, will be determined. A sonographic endometrial thickness < 15 mm using only the allocated therapy by randomisation is considered as successful treatment. Secondary outcome measures (patient satisfaction, complications, side effects and costs) will be registered using a case report form, patient diary and validated questionnaires (Short Form 36, EuroQol-VAS, Client Satisfaction Questionnaire, iMTA Productivity Cost Questionnaire). DISCUSSION: This trial will answer the question if, in case of EPF, after at least 1 week of expectant management, sequential treatment with mifepristone and misoprostol is more effective than misoprostol alone to achieve complete evacuation of the products of conception. TRIAL REGISTRATION: Clinicaltrials.gov (d.d. 02-07-2017): NCT03212352. Trialregister.nl (d.d. 03-07-2017): NTR6550. EudraCT number (d.d. 07-08-2017): 2017-002694-19. File number Commisie Mensgebonden Onderzoek (d.d. 07-08-2017): NL 62449.091.17.

The costs and cost effectiveness of providing second-trimester medical and surgical safe abortion services in Western Cape Province, South Africa.

BACKGROUND: In South Africa, access to second-trimester abortion services, which are generally performed using medical induction with misoprostol alone, is challenging for many women. We aimed to estimate the costs and cost effectiveness of providing three safe second-trimester abortion services (dilation and evacuation (D&E)), medical induction with mifepristone and misoprostol (MI-combined), or medical induction with misoprostol alone (MI-misoprostol)) in Western Cape Province, South Africa to aid policymakers with planning for service provision in South Africa and similar settings. METHODS: We derived clinical outcomes data for this economic evaluation from two previously conducted clinical studies. In 2013-2014, we collected cost data from three public hospitals where the studies took place. We collected cost data from the health service perspective through micro-costing activities, including discussions with site staff. We used decision tree analysis to estimate average costs per patient interaction (e.g. first visit, procedure visit, etc.), the total average cost per procedure, and cost-effectiveness in terms of the cost per complete abortion. We discounted equipment costs at 3%, and present the results in 2015 US dollars. RESULTS: D&E services were the least costly and the most cost-effective at $91.17 per complete abortion. MI-combined was also less costly and more cost-effective (at $298.03 per complete abortion) than MI-misoprostol (at $375.31 per complete abortion), in part due to a shortened inpatient stay. However, an overlap in the plausible cost ranges for the two medical procedures suggests that the two may have equivalent costs in some circumstances. CONCLUSION: D&E was most cost-effective in this analysis. However, due to resistance from health care providers and other barriers, these services are not widely available and scale-up is challenging. Given South Africa's reliance on medical induction, switching to the combined regimen could result in greater access to second-trimester services due to shorter inpatient stays without increasing costs.

Early IUD insertion after medically induced abortion.

OBJECTIVE: There is insufficient evidence on the continuation, safety and acceptability of immediate insertion of the intrauterine device (IUD) after medical abortion. The objective of the present study was to evaluate clinical outcomes of early IUD insertion, compared with those of delayed IUD insertion, following medical abortion. METHODS: Women undergoing medical abortion with mifepristone and misoprostol up to 49 days' gestation and opting for Copper T 380A IUD contraception underwent early (5-14 days after mifepristone) or delayed insertion (3-4 weeks after mifepristone). The primary outcome measure was 6 month IUD continuation rate after medical abortion. Secondary outcome measures included user acceptability and safety. RESULTS: Between October 2015 and October 2016, post-medical abortion IUD insertion was performed in 120 eligible women fulfilling the inclusion and exclusion criteria. There was no statistically significant difference in the continuation rates of the early and delayed IUD insertion groups at 6 months (76.7 versus 83.3%, p = .75). The 6 month IUD expulsion rates were 6.7 and 3.3% in the early and delayed insertion groups, respectively (p = .56). There were 10 (16.7%) removals in the early and eight (13.3%) in the delayed insertion groups (p = .77). Level of satisfaction with postabortal IUD use was comparable in both groups. Adverse events were rare and did not differ significantly between the two groups. CONCLUSION: We demonstrated high continuation rates, safety and acceptability of early IUD insertion after medical abortion.

Medication abortion: Potential for improved patient access through pharmacies.

OBJECTIVES: To discuss the potential for improving access to early abortion care through pharmacies in the United States. SUMMARY: Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas. CONCLUSION: Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women.

[Repeat induced abortion: A multicenter study on medical abortions in France in 2014]. / Caractéristiques des femmes ayant eu recours à plusieurs IVG ­ Enquête multicentrique sur les IVG médicamenteuses en France en 2014.

OBJECTIVES: To describe the social characteristics of women seeking a medical abortion, and the conditions of that abortion, according to whether they had one or more previous induced abortions. METHODS: An observational study was carried out in 11 French units in 2013-2014, among women 18 years or older. A self-administered questionnaire on the abortion context and social situation was given to them, as well as a diary to record the pain level for each of five days following the mifepristone intake. The sample included 453 women. RESULTS: Among the respondents, 22% had had one previous abortion and 8% had had two or more. Women having had a previous voluntary abortion were more often isolated and in a poorer social situation than women having their first abortion. CONCLUSION: Better support for contraception after abortion could reduce the number of repeated abortions.

Implementing medical abortion with mifepristone and misoprostol in Norway 1998-2013.

Background: Medical abortion with mifepristone and misoprostol was introduced in Norway in 1998, and since then there has been an almost complete change from predominantly surgical to medical abortions. We aimed to describe the medical abortion implementation process, and to compare characteristics of women obtaining medical and surgical abortion. Methods: Information from all departments of obstetrics and gynaecology in Norway on the time of implementation of medical abortion and abortion procedures in use up to 12 weeks of gestation was assessed by surveys in 2008 and 2012. We also analysed data from the National Abortion Registry comprising 223 692 women requesting abortion up to 12 weeks of gestation during 1998-2013. Results: In 2012, all hospitals offered medical abortion, 84.4% offered medical abortion at 9-12 weeks of gestation and 92.1% offered home administration of misoprostol. The use of medical abortion increased from 5.9% of all abortions in 1998 to 82.1% in 2013. Compared with women having a surgical abortion, women obtaining medical abortion had higher odds for undergoing an abortion at 4-6 weeks (adjusted OR 2.33; 95% confidence interval 2.28-2.38). Waiting time between registered request for an abortion until termination was reduced from 11.3 days in 1998 to 7.3 days in 2013. Conclusions: Norwegian women have gained access to more treatment modalities and simplified protocols for medical abortion. At the same time they obtained abortions at an earlier gestational age and the waiting time has been reduced.

Update on second-trimester surgical abortion.

PURPOSE OF REVIEW: To review the recent literature on surgical second-trimester abortion, with specific attention to cervical preparation techniques. RECENT FINDINGS: Confirming previous studies, a recent retrospective observational cohort study, including 54 911 abortions, estimated the total abortion-related complication rate to be 0.41% for second-trimester or later procedures. Cervical preparation is known to reduce risks associated with second-trimester dilation and evacuation (D&E). When considering adjuncts to osmotic dilators for cervical preparation prior to D&E after 16 weeks, both misoprostol and mifepristone are effective alone and in combination or as adjuncts to osmotic dilators. Misoprostol consistently has been shown to cause more pain and cramping than placebo, but is an effective adjunct to osmotic dilators after 16 weeks. Although mifepristone has fewer side-effects, at its current price, it may not be as cost-effective as misoprostol. SUMMARY: Second-trimester abortion is safe. The use of mifepristone and misoprostol for second-trimester abortion has improved safety and efficacy of medical and surgical methods when used alone or in combination and as adjuncts to osmotic dilators. An important aspect of D&E, cervical preparation, is not a one-size-fits-all practice; the approach and methods are contingent on patient, provider and setting and should consider all the evidence-based options.

"They made me go through like weeks of appointments and everything": Documenting women's experiences seeking abortion care in Yukon territory, Canada.

BACKGROUND: Abortion has been legal without restriction in Canada since 1988 and is recognized as a medically necessary service. However, research indicates that women still face numerous barriers to accessing care, challenges that are amplified for women living in rural, remote and northern regions in Canada. OBJECTIVES: This qualitative study aimed to document women's experiences seeking and obtaining abortion services while residing in Yukon Territory, identify financial and personal costs and explore avenues through which services could be improved. METHODS: We conducted 16 in-depth semi-structured phone interviews with women who accessed abortion services on/after January 1, 2005, while residing in the Yukon. We employed an iterative multiphase analytic approach centering on content and themes, using both inductive and deductive techniques. RESULTS: With the Yukon's sole facility offering first trimester abortions twice a month, women experienced difficulty navigating a fragmented process and long wait times. Women found the process of attending multiple pre-procedure appointments at multiple locations with multiple health care providers, all while enduring pregnancy symptoms and handling other life commitments, physically, financially and emotionally taxing. CONCLUSION: Efforts to streamline the process of obtaining an abortion and providing women with more information at the first point of contact would improve service access and quality. Mifepristone has the potential to improve access for rural and remote populations, reduce wait times and alleviate privacy concerns, but only if the medication abortion regimen is affordable and available at a range of service delivery points and provision requirements are aligned with the global evidence. IMPLICATIONS: By documenting women's experiences, the identified barriers and outlined suggestions for improvement offer realistic avenues through which current abortion services in Yukon Territory can be modified in order to increase access. This study highlights future reproductive health care initiatives that warrant prioritization in Canada's North.

Reaching women where they are: eliminating the initial in-person medical abortion visit.

The requirement that every woman desiring medical abortion must come in person to a clinical facility to obtain the drugs is a substantial barrier for many women. To eliminate this requirement in the United States, two key components of the standard initial visit would need to be restructured. First, alternatives to ultrasound and pelvic exam would need to be identified for ensuring that gestational age is within the limit for safe and effective treatment. This is probably feasible: for example, data from a large study suggest that in selected patients menstrual history is highly sensitive for this purpose. Second, the Food and Drug Administration would need to remove the medically unwarranted restriction on distribution of mifepristone. These two changes could allow provision of the service by a broader range of providers in nontraditional venues or even by telemedicine. Such options could have profound benefits in reducing cost and expanding access to abortion.