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.

Advancing Reproductive Health through Policy-Engaged Research in Abortion Care.

Mifepristone medication abortion was first approved in China and France more than 30 years ago and is now used in more than 60 countries worldwide. It is a highly safe and effective method that has the potential to increase population access to abortion in early pregnancy, closer to home. In both Canada and the United States, the initial regulations for distribution, prescribing, and dispensing of mifepristone were highly restricted. However, in Canada, where mifepristone was made available in 2017, most restrictions on the medication were removed in the first year of its availability. The Canadian regulation of mifepristone as a normal prescription makes access possible in community primary care through a physician or nurse practitioner prescription, which any pharmacist can dispense. In this approach, people decide when and where to take their medication. We explore how policy-maker-engaged research advanced reproductive health policy and facilitated this rapid change in Canada. We discuss the implications of these policy advances for self-management of abortion and demonstrate how in Canada patients "self-manage" components of the abortion process within a supportive health care system.

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.

A telemedicine model for abortion in South Africa: a randomised, controlled, non-inferiority trial.

BACKGROUND: Telemedicine for medical abortion increases access to safe abortion but its use has not been described in a controlled trial. We aimed to investigate the effectiveness, adherence, safety, and acceptability of a modified telemedicine protocol for abortion compared with standard care in a low-resource setting. METHODS: In this randomised, controlled, non-inferiority trial we recruited women seeking medical abortion at or before 9 gestational weeks at four public health clinics in South Africa. Participants were randomly allocated (1:1) by computer-generated blocks of varying sizes to telemedicine or standard care. The telemedicine group received asynchronous online abortion consultation and instruction, self-assessed gestational duration, and had a uterine palpation as a safety measure. Participants in this group took 200 mg mifepristone and 800 µg misoprostol at home. The standard care group received in-person consultation and instruction together with an ultrasound, took 200 mg mifepristone in clinic and 800 µg misoprostol at home. Our primary outcome was complete abortion after initial treatment, assessed at a 6-week interview. Our non-inferiority margin was 4%. Group differences were assessed by modified intention-to-treat (mITT) analysis and per protocol. The trial is registered at ClinicalTrials.gov, NCT04336358, and the Pan African Clinical Trials Registry, PACTR202004661941593. FINDINGS: Between Feb 28, 2020, and Oct 5, 2021, we enrolled 900 women, 153 (17·0%) of whom were discontinued before the abortion and were not included in the analysis. By mITT analysis, 355 (95·4%) of 372 women in the telemedicine group had a complete abortion compared with 338 (96·6%) of 350 in the standard care group (odds ratio 0·74 [95% CI 0·35 to 1·57]). The risk difference was -1·1% (-4·0 to 1·7). Among women who completed treatment as allocated (per protocol), 327 (95·6%) of 342 women in telemedicine group had complete abortion, compared with 338 (96·6%) of 350 in the standard care group (0·77 [0·36 to 1·68]), with a risk difference of -1·0% (-3·8 to 1·9). One participant (in the telemedicine group) had a ruptured ectopic pregnancy, and a further four participants were admitted to hospital (two in each group), of whom two had blood transfusions (one in each group). INTERPRETATION: Asynchronous online consultation and instruction for medical abortion and home self-medication, with uterine palpation as the only in-person component, was non-inferior to standard care with respect to rates of complete abortion, and did not affect safety, adherence, or satisfaction. FUNDING: Grand Challenges Canada and the Swedish Research Council.

Mifepristone: A Safe Method of Medical Abortion and Self-Managed Medical Abortion in the Post-Roe Era.

BACKGROUND: The U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision on June 24, 2022 effectively overturned federal constitutional protections for abortion that have existed since 1973 and returned jurisdiction to the states. Several states implemented abortion bans, some of which banned abortion after 6 weeks and others that permit abortion under limited exceptions, such as if the health or the life of the woman is in danger. Other states introduced bills that define life as beginning at fertilization. As a result of these new and proposed laws, the future availability of mifepristone, one of two drugs used for medical abortion in the United States, has become the topic of intense debate and speculation. AREAS OF UNCERTAINTY: Although its safety and effectiveness has been confirmed by many studies, the use of mifepristone has been politicized regularly since its approval. Areas of future study include mifepristone for induction termination and fetal demise in the third trimester and the management of leiomyoma. DATA SOURCES: PubMed, Society of Family Planning, American College of Obstetricians and Gynecologists, the World Health Organization. THERAPEUTIC ADVANCES: The use of no-touch medical abortion, which entails providing a medical abortion via a telehealth platform without a screening ultrasound or bloodwork, expanded during the COVID-19 pandemic, and studies have confirmed its safety. With the Dobbs decision, legal abortion will be less accessible and, consequently, self-managed abortion with mifepristone and misoprostol will become more prevalent. CONCLUSIONS: Mifepristone and misoprostol are extremely safe medications with many applications. In the current changing political climate, physicians and pregnancy-capable individuals must have access to these medications.

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.

Should COVID-specific arrangements for abortion continue? The views of women experiencing abortion in Britain during the pandemic.

BACKGROUND: During the COVID-19 pandemic, the British governments issued temporary approvals enabling the use of both medical abortion pills, mifepristone and misoprostol, at home. This permitted the introduction of a fully telemedical model of abortion care with consultations taking place via telephone or video call and medications delivered to women's homes. The decision was taken by the governments in England and Wales to continue this model of care beyond the original end date of April 2022, while at time of writing the approval in Scotland remains under consultation. METHODS: We interviewed 30 women who had undergone an abortion in England, Scotland or Wales between August and December 2021. We explored their views on the changes in abortion service configuration during the pandemic and whether abortion via telemedicine and use of abortion medications at home should continue. RESULTS: Support for continuation of the permission to use mifepristone and misoprostol at home was overwhelmingly positive. Reasons cited included convenience, comfort, reduced stigma, privacy and respect for autonomy. A telemedical model was also highly regarded for similar reasons, but for some its necessity was linked to safety measures during the pandemic, and an option to have an in-person interaction with a health professional at some point in the care pathway was endorsed. CONCLUSIONS: The approval to use abortion pills at home via telemedicine is supported by women having abortions in Britain. The voices of patients are essential to shaping acceptable and appropriate abortion service provision.

Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study.

Importance: Screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone. However, few US-based studies have been conducted on the outcomes and safety of this novel model of care. Objective: To evaluate the outcomes and safety of a history-based screening, no-test approach to medication abortion care. Design, Setting, and Participants: This retrospective cohort study included patients obtaining a medication abortion without preabortion ultrasonography or pelvic examination between February 1, 2020, and January 31, 2021, at 14 independent, Planned Parenthood, academic-affiliated, and online-only clinics throughout the US. Exposures: Medications for abortion provided without preabortion ultrasonography or pelvic examination and dispensed to patients in person or by mail. Main Outcomes and Measures: Effectiveness, defined as complete abortion after 200 µg of mifepristone and up to 1600 µg of misoprostol without additional intervention, and major abortion-related adverse events, defined as hospital admission, major surgery, or blood transfusion. Results: The study included data on 3779 patients with eligible abortions. The study participants were racially and ethnically diverse and included 870 (23.0%) Black patients, 533 (14.1%) Latinx/Hispanic patients, 1623 (42.9%) White patients, and 327 (8.7%) who identified as multiracial or with other racial or ethnic groups. For most (2626 [69.5%]), it was their first medication abortion. Patients lived in 34 states, and 2785 (73.7%) lived in urban areas. In 2511 (66.4%) abortions, the medications were dispensed in person; in the other 1268 (33.6%), they were mailed to the patient. Follow-up data were obtained for 2825 abortions (74.8%), and multiple imputation was used to account for missing data. Across the sample, 12 abortions (0.54%; 95% CI, 0.18%-0.90%) were followed by major abortion-related adverse events, and 4 patients (0.22%; 95% CI, 0.00%-0.45%) were treated for ectopic pregnancies. Follow-up identified 9 (0.40%; 95% CI, 0.00%-0.84%) patients who had pregnancy durations of greater than 70 days on the date the mifepristone was dispensed that were not identified at screening. The adjusted effectiveness rate was 94.8% (95% CI, 93.6%-95.9%). Effectiveness was similar when medications were dispensed in person (95.4%; 95% CI, 94.1%-96.7%) or mailed (93.3%; 95% CI, 90.7%-95.9%). Conclusions and Relevance: In this cohort study, screening for medication abortion eligibility by history alone was effective and safe with either in-person dispensing or mailing of medications, resulting in outcomes similar to published rates of models involving ultrasonography or pelvic examination. This approach may facilitate more equitable access to this essential service by increasing the types of clinicians and locations offering abortion care.

Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.

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.

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.

Mifepristone prior to osmotic dilators for dilation and evacuation cervical preparation: A randomized, double-blind, placebo-controlled pilot study.

OBJECTIVES: To evaluate mifepristone impact on osmotic dilator placement and procedural outcomes when given 18 to 24 hours before dilator placement for dilation and evacuation (D&E) at 18 weeks 0 days to 23 weeks 6 days gestation. STUDY DESIGN: We performed a randomized, double-blind, placebo-controlled trial from April 2019 through February 2021, enrolling participants undergoing osmotic dilator (Dilapan) placement for a planned, next-day D&E. Participants took mifepristone 200 mg or placebo orally 18 to 24 hours before dilator placement. We used a gestational age-based protocol for minimum number of dilators. Our primary outcome was the proportion of participants for whom 2 or more additional dilators could be placed compared to the minimum gestational age-based standard. We secondarily evaluated cervical dilation after dilator removal in the operating room, subjective procedure ease, and complication rates (cervical laceration, uterine perforation, blood transfusion, infection, hospitalization, or extramural delivery). RESULTS: Of the planned 66 participants, we enrolled 44 (stopped due to coronavirus disease 2019-related obstacles), and 41 (19 mifepristone; 22 placebo) completed the study. We placed 2 or more additional dilators compared to standard in 7 (36.8%) and 3 (13.6%) participants after mifepristone and placebo, respectively (p = 0.14). We measured greater median initial cervical dilation in the mifepristone (3.2 cm[2.6-3.6]) compared to placebo (2.6 cm[2.2-3.0]) group, p = 0.03. Surgeon's perception of procedure being "easy" (8/19[42.1] vs 9/22[40.9], respectively, p = 1.00) and complication rate (3/19[15.8%] vs 3/22[13.6], respectively, p = 1.00) did not differ. CONCLUSION: Our underpowered study did not demonstrate a difference in cervical dilator placement, but mifepristone 18 to 24 hours prior to dilators increases cervical dilation without increasing complications. IMPLICATIONS: Mifepristone 18 to 24 hours prior to cervical dilator placement may be a useful adjunct to cervical dilators based on increased cervical dilation at time of procedure; however, logistical barriers, such as an additional visit, may preclude routine adoption without definite clinical benefit.