Systematic Review of the Effectiveness, Safety, and Acceptability of Mifepristone and Misoprostol for Medical Abortion in Low- and Middle-Income Countries.

OBJECTIVE: Abortion-related complications remain one of the leading causes of maternal morbidity and mortality worldwide. Nearly half of all abortions are unsafe, and the vast majority of these occur in low- and middle-income countries. The use of mifepristone with misoprostol for medical abortion has been proposed and implemented to improve abortion safety. DATA SOURCES: A systematic review of the literature was conducted in PubMed, Embase, Cochrane, and CINAHL. STUDY SELECTION: Criteria for study inclusion were first-trimester abortion, use of mifepristone with misoprostol, and low- or middle-income country status as designated by the World Health Organization. DATA EXTRACTION: Results for effectiveness, safety, acceptability, and qualitative information were assessed. DATA SYNTHESIS: The literature search resulted in 181 eligible articles, 52 of which met our criteria for inclusion. A total of 34 publications reported effectiveness data on 25 385 medical abortions. The average effectiveness rate with mifepristone 200 mg and misoprostol 800 µg was 95% up to 63 days gestation. A sensitivity analysis was performed to assume that all women lost to follow-up failed treatment, and the recalculated effectiveness rate remained high at 93%. The average continuing pregnancy rate was 0.6%. A total of 22 publications reported safety and acceptability data on 17 381 medical abortions. Only 0.8% abortions required presentation to hospital, and 87% of patients found the side effects of treatment acceptable. Overall, 95% of women were satisfied with their medical abortion, 94% would choose the method again, and 94% would recommend this method to a friend. A total of 16 publications reported qualitative results and the majority supported positive patient experiences with medical abortion. CONCLUSIONS: Mifepristone and misoprostol is highly effective, safe, and acceptable to women in low- and middle-income countries, making it a feasible option for reducing maternal morbidity and mortality worldwide.

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.

Medical abortion reversal: science and politics meet.

Medical abortion is a safe, effective, and acceptable option for patients seeking an early nonsurgical abortion. In 2014, medical abortion accounted for nearly one third (31%) of all abortions performed in the United States. State-level attempts to restrict reproductive and sexual health have recently included bills that require physicians to inform women that a medical abortion is reversible. In this commentary, we will review the history, current evidence-based regimen, and regulation of medical abortion. We will then examine current proposed and existing abortion reversal legislation. The objective of this commentary is to ensure physicians are armed with rigorous evidence to inform patients, communities, and policy makers about the safety of medical abortion. Furthermore, given the current paucity of evidence for medical abortion reversal, physicians and policy makers can dispel bad science and misinformation and advocate against medical abortion reversal legislation.

[General medical practice and medicinal voluntary termination of pregnancy in Grand Est, France]. / Médecine générale de ville et interruption volontaire de grossesse médicamenteuse en région Grand Est, France.

BACKGROUND: Access to VTOP (Voluntary Termination of Pregnancy) is a national priority in France. Once legalized in 1975, several laws contributed to improve access to VTOP, such as the 2004 family planning law which enabled urban practitioners to carry out orthogenic work. This law was supplemented by the 2016 health care modernization act. On the whole, the organization for VTOP access in the Grand Est region, complies with legislation and recommendations. However, private practitioners contribute little to this activity. Since there are very few gynecologists in certain areas (whether private or hospital practitioners), general practitioners seem to be the first line actors. This study aims at describing the orthogenic work of urban, government-regulated general practitioners, in the Grand Est region of France. MATERIAL AND METHOD: Data were collected from semi-directive interviews with the set of the government-regulated general practitioners doing family planning work in the Grand Est region. RESULTS: Out of the fifteen doctors who were interviewed, twelve actually suggested family planning work to their patients, and out of those twelve, seven practiced it in reality. What comes out is that the main motivation of professionals was to improve access to VTOP. Besides, they also mentioned the importance of being able to answer a real demand from their patients as well as an interest in gynecology. Hence the professionals' practice both benefits from services provided to their patients and from a diversification of their work, even though they regret that the value of this time-consuming procedure is not recognized. This study also brings out that although these medical acts were individualized and allowed better confidentiality for the patient, the risk for complications and home birth remained an obstacle. Finally, it emerges that the whole set of recommendations was not always implemented. DISCUSSION: Urban family planning, performed by general practitioners, seems to be a major line to focus on for better timeliness and quality of care. However, some obstacles have been identified such as its specificity, its time-consuming aspect, its lack of status, as well as the difficulty to comply with recommendations. CONCLUSION: The development of this practice is necessary to maintain an appropriate response to VTOP but actions to remove certain obstacles have to be carried out.

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia.

OBJECTIVES: The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia. METHODS: Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 µg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery. RESULTS: A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers. CONCLUSION: The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 µg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks' gestation is an effective and acceptable option for women.

Medical Abortion.

OBJECTIVE: This guideline reviews the evidence relating to the provision of first-trimester medical induced abortion, including patient eligibility, counselling, and consent; evidence-based regimens; and special considerations for clinicians providing medical abortion care. INTENDED USERS: Gynaecologists, family physicians, registered nurses, midwives, residents, and other healthcare providers who currently or intend to provide pregnancy options counselling, medical abortion care, or family planning services. TARGET POPULATION: Women with an unintended first trimester pregnancy. EVIDENCE: Published literature was retrieved through searches of PubMed, MEDLINE, and Cochrane Library between July 2015 and November 2015 using appropriately controlled vocabulary (MeSH search terms: Induced Abortion, Medical Abortion, Mifepristone, Misoprostol, Methotrexate). Results were restricted to systematic reviews, randomized controlled trials, clinical trials, and observational studies published from June 1986 to November 2015 in English. Additionally, existing guidelines from other countries were consulted for review. A grey literature search was not required. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force for Preventive Medicine rating scale (Table 1). BENEFITS, HARMS AND/OR COSTS: Medical abortion is safe and effective. Complications from medical abortion are rare. Access and costs will be dependent on provincial and territorial funding for combination mifepristone/misoprostol and provider availability. SUMMARY STATEMENTS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care RECOMMENDATIONS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care.

Women's experiences with medication for menstrual regulation in Bangladesh.

Menstrual regulation has been legal in Bangladesh since 1974, but the use of medication for menstrual regulation is new. In this study, we sought to understand women's experiences using medication for menstrual regulation in Bangladesh. We conducted 20 in-depth interviews with rural and urban women between December 2013 and February 2014. All interviews were audiotaped, transcribed, translated, computer recorded and coded for analysis. The majority of women in our study had had positive experiences with medication for menstrual regulation and successful outcomes, regardless of whether they obtained their medication from medicine sellers/pharmacies, doctors or clinics. Women were strongly influenced by health providers when deciding which method to use. There is a need to educate not only women of reproductive age, but also communities as a whole, about medication for menstrual regulation, with a particular emphasis on cost and branding the medication. Continued efforts to improve counselling by providers about the dose, medication and side-effects of medication for menstrual regulation, along with education of the community about medication as an option for menstrual regulation, will help to de-stigmatise the procedure and the women who seek it.

Feasibility and effectiveness of unintended pregnancy prevention with low-dose mifepristone combined with misoprostol before expected menstruation.

STUDY QUESTION: What is the efficacy of maintaining or restoring non-pregnant status with low-dose mifepristone combined with misoprostol administered before expected menstruation? SUMMARY ANSWER: Low-dose mifepristone and misoprostol administered at the time of expected menstruation was effective and safe in maintaining or restoring non-pregnant status, with no obvious menstrual disturbance. WHAT IS KNOWN ALREADY: Menstrual regulation involves the medical or mechanical stimulation of uterine sloughing in women with up to 2-3 weeks of menstrual delay. Low-dose mifepristone plus misoprostol is efficacious for termination of ultra-early pregnancy (≤ 35 days of amenorrhoea) with no obvious menstrual disturbance. STUDY DESIGN, SIZE, DURATION: A total of 678 women fulfilled all criteria and were recruited. Seventeen women dropped out after deciding to remain pregnant and 11 others were lost to follow-up. Thus, data from 650 women who completed the procedure were included in analyses. Participants were enrolled at any time during their menstrual cycle and administered medication 1 day before expected menstruation. The end of the study was defined on a per-patient basis as the date of completion of the post-treatment menstrual cycle. The primary outcome was the efficacy of abortion induction (for pregnant women) or menstrual regulation (for non-pregnant women). PARTICIPANTS, SETTING, METHODS: Women with regular menstrual cycles (25-35 days) were voluntarily recruited for this study between February 2012 and December 2014. Serum ß-hCG was measured before mifepristone intake. Mifepristone (50 mg) was administered orally 1 day before expected menstruation and 200 µg misoprostol was administered orally on the day of expected menstruation. Efficacy, disturbance in bleeding patterns in the treatment and post-treatment cycles, satisfaction with the treatment, and subsequent contraception preference were analysed. MAIN RESULTS AND THE ROLE OF CHANCE: Retrospective analysis of serum ß-hCG levels at admission indicated that 23.3% (158/678) of the women were pregnant. The success rate for pregnancy termination was 98.6% (136/138). Two women (1.5%, 2/138) had ongoing pregnancy that was subsequently terminated surgically. The overall bleeding induction rate within 7 days was 98.3% (639/650), with 100% (138/138) in pregnant participants and 97.9% (501/512) in non-pregnant participants. Most pregnant and non-pregnant participants experienced no significant menstrual disturbance during the treatment [96.3% (131/136) versus 97.6% (489/501)] or post-treatment [97.8% (133/136) versus 98.4% (493/501)] menstrual cycle. The general rate of satisfaction with the treatment was 96.7% (618/639). Generally, 36.0% (230/639) of participants preferred to use the regimen as a routine contraception method versus the 64.0% (409/639) who preferred to use it as a remedy for pregnancy prevention after unprotected sex (P < 0.001). LIMITATIONS, REASONS FOR CAUTION: Study participants were recruited from a single region; further studies should include participants from multiple centres in different cities and nations. Given the uncertain efficacy of regimen reuse, the assessment of efficacy was based solely on the first treatment administration. Studies with larger samples and long-term follow-up may provide more data on whether repeated use of this regimen hampers its efficacy. WIDER IMPLICATIONS OF THE FINDINGS: Menstrual regulation with low-dose mifepristone and misoprostol at expected menstruation can be efficacious and highly acceptable to maintain or restore non-pregnant status, which may have potential for routine contraception.

Pharmacy dispensing of abortion pills in Ghana: experiences of pharmacy workers and users.

BACKGROUND: Self-managed medical abortions are generally safe; however, pharmacy provision of abortion pills is against the Ghanaian abortion law. Nevertheless, evidence shows increasing numbers of women use it. An understanding of the influence of the law on pharmacies dispensing abortifacients and women who needed hospital care after using these pills is lacking. This study aimed to address this gap. METHODS: We conducted 26 interviews with eight pharmacy workers and 18 women who sought hospital care after using abortion pills. Study participants were recruited from private pharmacies and hospitals within the Ashanti Region of Ghana between June 2017 and March 2018. We employed phenomenology in analysing the data. RESULTS: Results show that criminalising medical abortion care from pharmacies does not stop abortions but rather drives it to be provided without oversight. It also denied pharmacy workers formal training in medical abortion care, resulting in situations where they failed to provide correct dosage information, used their discretion in determining the price of abortifacients and to whom they would dispense the pills. For women, it contributed to limited interaction with providers and an inability to insist on their rights even in instances where the pills were sold at exorbitant prices. CONCLUSIONS: Due to the increasing numbers of Ghanaian women using medical abortion pills from pharmacies, although it is illegal, the ideal would be for medical abortion pills to be made legally available through pharmacies. Given that this may not occur in the short term, an immediate solution would be to upskill pharmacy workers.

Immediate versus delayed medical treatment for first-trimester miscarriage: a randomized trial.

OBJECTIVE: To compare immediate vs delayed medical treatment for first-trimester miscarriage. STUDY DESIGN: Randomized open-label trial in a university hospital gynecologic emergency department. Between April 2003 and April 2006, 182 women diagnosed with spontaneous abortion before 14 weeks' gestation were assigned to immediate medical treatment (oral mifepristone, followed 48 hours later by vaginal misoprostol, n = 91) or sequential management (1 week of watchful waiting followed, if necessary, by the above-described medical treatment, n = 91). Vacuum aspiration was performed in case of treatment failure, hemorrhage, pain, infection, or patient request. RESULTS: Compared with immediate medical treatment, sequential management resulted in twice as many vacuum aspirations overall (43.5% vs 19.1%; P < .001), 4 times as many emergent vacuum aspirations (20% vs 4.5%; P = .001), and twice as many unplanned visits to the emergency department (34.1% vs 16.9%; P = .009). CONCLUSION: Delaying medical treatment of first-trimester miscarriage increases the rate of unplanned surgical uterine evacuation.

Efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone for medical abortion.

OBJECTIVES: To evaluate the efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone in medical abortion of ≤56 days. STUDY DESIGN: One hundred pregnant women having gestational age ≤56 days were randomized to group A and group B. In group A, patients received 200 mg mifepristone on day 1, followed by buccal misoprostol 800 µg on day 2, and in group B patients received 800 µg buccal misoprostol only on day 1. MAIN OUTCOME MEASURES: Complete abortion was the principal outcome measure. Secondary outcome measures were side-effects and acceptability. RESULTS: Forty-six (92%) patients in group A and 37 (74%) patients in group B aborted successfully (p value 0.017). Four (8%) patients in group A and eight (16%) patients in group B had incomplete abortion with retained products of conception. In group B, three (6%) patients had missed abortion and two (4%) patients had continued pregnancy whereas none of the patients in group A had missed abortion or continued pregnancy. The overall method acceptance was 100% whereas the overall route acceptance was 83%. CONCLUSION: Misoprostol-alone regimen is a low-cost regimen as compared to mifepristone/misoprostol regimen. Though the efficacy of mifepristone followed by buccal misoprostol is better, buccal misoprostol alone can be used for termination of pregnancy in patients where mifepristone is either unavailable or contraindicated.

Family medicine provision of online medication abortion in three US states during COVID-19.

OBJECTIVE: To examine provision of direct-to-patient medication abortion during COVID-19 by United States family physicians through a clinician-supported, asynchronous online service, Aid Access. STUDY DESIGN: We analyzed data from United States residents in New Jersey, New York, and Washington who requested medication abortion from 3 family physicians using the online service from Aid Access between April and November 2020. This study seeks to examine individual characteristics, motivations, and geographic locations of patients receiving abortion care through the Aid Access platform. RESULTS: Over 7 months, three family physicians using the Aid Access platform provided medication abortion care to 534 residents of New Jersey, New York, and Washington. There were no demographic differences between patients seeking care in these states. A high percentage (85%) were less than 7 weeks gestation at the time of their request for care. The reasons patients chose Aid Access for abortion services were similar regardless of state residence. The majority (71%) of Aid Access users lived in urban areas. Each family physician provided care to most counties in their respective states. Among those who received services in the three states, almost one-quarter (24%) lived in high Social Vulnerability Index (SVI) counties, with roughly one-third living in medium-high SVI counties (33%), followed by another quarter (26%) living in medium-low SVI counties. CONCLUSIONS: Family physicians successfully provided medication abortion in three states using asynchronous online consultations and medications mailed directly to patients. IMPLICATIONS: Primary care patients are requesting direct-to-patient first trimester abortion services online. By providing abortion care online, a single provider can serve the entire state, thus greatly increasing geographic access to medication abortion.

Post Abortion Care and Management After Induced Abortion During the COVID-19 Pandemic: A Chinese Expert Consensus.

The rapid spread of novel coronavirus (COVID-19) has posed complex challenges to global public health. During this pandemic period, access to essential services including post-abortion care (PAC) has been disrupted. Along with the clinical management of the disease in women, protection of the healthcare workers and medical staff from nosocomial infection is important to ensure infection control. Thus, in order to implement the proper contraceptive measures and to reduce the rate of repeated abortion, the family planning group of minimally invasive gynecological branch of the Liaoning Medical Association organized a committee of experts to formulate guidance and suggestions to ensure the timely treatment and surgery of women opting for abortion, the implementation of PAC, implementation of safe contraceptive measures after surgery, and the protection of healthcare professionals and medical staff from infection. We believe these guidelines might be helpful for obstetrics and gynecology departments in China and globally, as well for women who wish to undergo abortion during these unprecedented times.

Family Physicians' Role in Simplifying Medication Abortion During the COVID-19 Pandemic.

Despite first trimester abortion being common and safe, there are numerousrestrictions that lead to barriers to seeking abortion care. The COVID-19 pandemic hasonly exacerbated these barriers, as many state legislators push to limit abortion accesseven further. During this pandemic, family physicians across the country haveincorporated telemedicine into their practices to continue to meet patient needs.Medication abortion can be offered to patients by telemedicine in most states, andmultiple studies have shown that labs, imaging, and physical exam may not beessential in all cases. Family physicians are well-poised to incorporate medicationabortion into their practices using approaches that limit the spread of the coronavirus,ultimately increasing access to abortion in these unprecedented times.

A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.

OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.

Closing the gap: actualising shared decision-making through effective medication abortion patient follow-up care.

BACKGROUND: Effective care dearth in USA healthcare systems can be augmented by patient engagement and shared decision-making (SDM). These effective care strategies can facilitate medical abortion follow-up care (ensuring patients are not experiencing a continuing pregnancy) and follow-up options access. LOCAL PROBLEM: The quality improvement project clinic had a state-mandated waiting period, requiring additional visits. This delayed care for all abortion patients, creating travel, and cost barriers. The clinic had some of the lowest medical abortion follow-up rates out of its entire national network. METHODS: Four 'Plan-Do-Study-Act' (PDSA) cycles built on clinical changes, implementing an Agency for Healthcare Research and Quality serum human chorionic gonadotropin guideline. Medical abortion patient cohort size doubled during each PDSA cycle. INTERVENTIONS: Through four interventions (team engagement, patient engagement, Beta follow-up and contraception SDM), standardised follow-up care was integrated into clinic workflow with contraception SDM tools and an Option Grid. RESULTS: Most intervention measures were successful, with staff offering follow-up options counselling to all medical abortion patients by the end of the project. The Beta follow-up rate (84%) was higher than the overall follow-up rate (52%-73%), but the goal of a 92% overall follow-up rate was not met. Contraception SDM streamlined counselling but long-acting reversible contraception insertion rates did not increase. CONCLUSIONS: Effective care enabled the majority of medical abortion patients to choose Beta follow-up as their preferred follow-up method, especially those with a travel barrier. Beta follow-up gives assurance to close the follow-up gap over time.