Telehealth Medication Abortion in Primary Care: A Comparison to Usual in-Clinic Care.

INTRODUCTION: Providing abortion in primary care expands access and alleviates delays. The 2020 COVID-19 public health emergency (PHE) led to the expansion of telehealth, including medication abortion (MAB). This study evaluates the accessibility of novel telehealth MAB (teleMAB) initiated during the PHE, with the lifting of mifepristone restrictions, compared with traditional in-clinic MAB offered before the PHE at a Massachusetts safety-net primary care organization. METHODS: We conducted a retrospective electronic medical record review of 267 MABs. We describe sociodemographic, care access, and complete abortion characteristics and compare differences between teleMAB and in-clinic MABs using Chi-squared test, fisher's exact test, independent t test, and Wilcoxon rank sum. We conducted logistic regression to examine differences in time to care (6 days or less vs 7 days or more). RESULTS: 184 MABs were eligible for analysis (137 in-clinic, 47 teleMAB). Patients were not significantly more likely to receive teleMAB versus in-clinic MAB based on race, ethnicity, language, or payment. Completed abortion did not significantly differ between groups (P = .187). Patients received care more quickly when accessing teleMAB compared with usual in-clinic MAB (median 3 days, range 0 to 20 vs median 6 days, range 0 to 32; P < . 001). TeleMAB patients had 2.29 times the odds of having their abortion appointment within 6 days compared with in-clinic (95% CI: 1.13, 4.86). CONCLUSION: TeleMAB in primary care is as effective, timelier, and potentially more accessible than in-clinic MAB when in-person mifepristone regulations were enforced. TeleMAB is feasible and can promote patient-centered and timely access to abortion care.

Abortion pills on TV: An exploratory study of the associations between abortion plotline viewership and beliefs regarding in-clinic and self-managed medication abortion.

OBJECTIVES: Entertainment television is an influential source of health information, including about reproductive health. We investigated the association between exposure to television plotlines about medication abortion on audience awareness and beliefs about medication abortion. STUDY DESIGN: We administered a national cross-sectional online survey from December 2021 to January 2022 with a probability-based sample of people assigned female at birth. We asked respondents to select plotlines they had seen from a list of seven that portrayed medication abortion. Among the 3425 people who responded to plotline items, 3340 responded to our outcome measures. Using weighed multivariable analyses, we examined adjusted relationships between exposure to specific types of abortion plotlines and awareness of and beliefs about medication abortion medical safety. RESULTS: We found that audience exposure to medication abortion plotlines in which the medication abortion was obtained from a clinic and portrayed as safe was associated with greater awareness of medication abortion compared to nonexposure (RR: 1.68; 95% CI: 1.17, 2.40). Exposure to plotlines that portrayed MA or self-managed MA as safe was associated with audience beliefs that medication abortion is safe. CONCLUSIONS: This study demonstrates that the content of abortion plotlines and exposure to accurate information may be connected to audience awareness of and beliefs about abortion. IMPLICATIONS: In a climate of misinformation about abortion, audience exposure to medically accurate television plotlines about medication abortion may be an effective way to increase awareness of medication abortion and influence beliefs about medication abortion safety.

Requests for Self-managed Medication Abortion Provided Using Online Telemedicine in 30 US States Before and After the Dobbs v Jackson Women's Health Organization Decision.

This study assesses changes in online telemedicine requests to self-manage abortions with medications before vs after the Dobbs v Jackson Women's Health Organization Supreme Court decision overturning Roe v Wade.

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.

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.

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.

Abortion experiences and preferences of transgender, nonbinary, and gender-expansive people in the United States.

BACKGROUND: Transgender, nonbinary, and gender-expansive people who were assigned female or intersex at birth experience pregnancy and have abortions. Scarce data have been published on individual abortion experiences or preferences of this understudied population. OBJECTIVE: This study aimed to fill existing evidence gaps on the abortion experiences and preferences of transgender, nonbinary, and gender-expansive people in the United States to inform policies and practices to improve access to and quality of abortion care for this population. STUDY DESIGN: In 2019, we recruited transgender, nonbinary, and gender-expansive people who were assigned female or intersex at birth at the age of ≥18 years from across the United States to participate in an online survey about sexual and reproductive health recruited through The Population Research in Identities and Disparities for Equality Study and online postings. We descriptively analyzed closed- and open-ended survey responses related to pregnancy history, abortion experiences, preferences for abortion method, recommendations to improve abortion care for transgender, nonbinary, and gender-expansive people, and respondent sociodemographic characteristics. RESULTS: Most of the 1694 respondents were <30 years of age. Respondents represented multiple gender identities and sexual orientations and resided across all 4 United States Census Regions. Overall, 210 respondents (12%) had ever been pregnant; these 210 reported 433 total pregnancies, of which 92 (21%) ended in abortion. For respondents' most recent abortion, 41 (61%) were surgical, 23 (34%) were medication, and 3 (5%) were another method (primarily herbal). Most recent abortions took place at ≤9 weeks' gestation (n=41, 61%). If they were to need an abortion today, respondents preferred medication abortion over surgical abortion in a 3:1 ratio (n=703 vs n=217), but 514 respondents (30%) did not know which method they would prefer. The reasons for medication abortion preference among the 703 respondents included a belief that it is the least invasive method (n=553, 79%) and the most private method (n=388, 55%). To improve accessibility and quality of abortion care for transgender, nonbinary, and gender-expansive patients, respondents most frequently recommended that abortion clinics adopt gender-neutral or gender-affirming intake forms, that providers use gender-neutral language, and that greater privacy be incorporated into the clinic. CONCLUSION: These data contribute substantially to the evidence base on individual experiences of and preferences for abortion care for transgender, nonbinary, and gender-expansive people. Findings can be used to adapt abortion care to better include and affirm the experiences of this underserved population.

Different dosing intervals of mifepristone-misoprostol for second-trimester termination of pregnancy: A meta-analysis and systematic review.

OBJECTIVE: To compare 1- and 2-day drug administration interval between mifepristone and misoprostol for second-trimester pregnancy termination and provide evidence-based recommendations. METHODS: Search strategy: the search was performed in Pubmed, EMBASE, and Cochrane Library for the relevant published studies from their establishment to March 2020. SELECTION CRITERIA: randomized controlled trials (RCTs) comparing 1- and 2-day time interval of mifepristone-misoprostol for termination of pregnancy during second-trimester pregnancy were considered. Data were processed using Revman 5.3 software. RESULTS: Meta-analyses of three RCTs showed no significant difference was reported in the induction-to-abortion time and successful abortion rate between 1- and 2-day mifepristone and misoprostol intervals. Statistical difference was not identified in the induction-to-abortion time between the two drug administration intervals in nulliparous or parous women. CONCLUSIONS: Both 1- and 2-day dosing intervals between mifepristone and misoprostol are suitable for clinical use for second-trimester medical termination of pregnancy.

Expulsion at home for early medical abortion: A systematic review with meta-analyses.

INTRODUCTION: The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9+0  weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion. MATERIAL AND METHODS: We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9+0  weeks' gestational age with pregnancies of 9+1 -10+0  weeks or >10+1  weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE. RESULTS: Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9+0 and >9+0  weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9+0  weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9+1 -10+0  weeks' gestation with pregnancies of >10+0  weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up. CONCLUSIONS: Women who are having a medical abortion and will be taking mifepristone up to and including 10+0  weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10+0  weeks.

Exploring potential interest in missed period pills in two US states.

OBJECTIVE: Missed period pills (MPP) are uterine evacuation medications used for treatment of delayed menses without prior pregnancy confirmation. This study explores potential interest in missed period pills in two US states. STUDY DESIGN: We enrolled people seeking pregnancy test services at nine health centers in two US states between June 2015 and October 2017. Participants completed an anonymous questionnaire containing closed- and open-ended questions about background characteristics, reproductive practices, pregnancy feelings and intentions, abortion attitudes, and MPP interest. We used ordered logistic regression to identify factors associated with MPP interest and inductive content analysis to identify recurring qualitative themes related to MPP interest or disinterest. RESULTS: In all, 678 people completed the survey and 286/678 (42%) indicated interest in missed period pills. Interest was greatest (129/185 or 70%) among those who would be unhappy if pregnant. Variables associated with interest in the multivariate analyses were age ≥ 35, nulliparity, prior abortion and contraceptive use, recent use of emergency contraception, pregnancy feelings and intentions, and abortion attitudes (p < .05). Variables not associated with interest included state of residence, educational attainment, ethnicity, religious affiliation, and frequency of religious attendance. Key reasons for interest were to prevent, avoid or terminate pregnancy; and psychological or emotional benefits, including management of abortion stigma. Reasons for non-interest included concerns about safety or side effects, desire to be pregnant or have a baby, and not wanting to abort or hurt the fetus/baby. CONCLUSION: If missed period pills were available in the United States, demand might be substantial and wide-ranging across demographic groups. IMPLICATIONS: Our findings suggest that some people with missed periods do not desire pregnancy confirmation before taking medications that might disrupt a pregnancy. As a result, provision of missed period pills in the United States would expand reproductive service options and could improve the delivery of patient-centered care.

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.

The role of day 0 and day 4 ß-human chorionic gonadotropin values and initial ultrasound findings in predicting the success of methotrexate treatment in ectopic pregnancy.

OBJECTIVES: To determine the role of baseline ultrasound findings and the changes between ß- human chorionic gonadotropin (hCG) values on day 0 to day 4 in patients receiving single-dose methotrexate (MTX) therapy for tubal ectopic pregnancy. MATERIAL AND METHODS: One hundred fourteen patients who were hospitalized with a diagnosis of ectopic pregnancy and treated with single-dose methotrexate were included in this retrospective study. The successful treatment group (n = 88) comprised patients in whom serum ß-hCG levels were resolved with single-dose methotrexate treatment, and the failed treatment group (n = 26) included patients who received second dose methotrexate and/or surgery. Ultrasound findings, laboratory findings, and serum ß-hCG values at the time of admission and D4 and D7 ß-hCG values were compared. RESULTS: The success rate of single-dose methotrexate treatment was 77.2%. In the successful treatment group, the initial ß-hCG values of the patients were lower than the unsuccessful treatment group (1479.14 ± 1253.49, 4442.88 ± 3392.58, respectively) (p = 0.0001). A decrease of more than 35% between D0-D4 increased the probability of successful treatment (p = 0.017). Although ectopic focus size and abdominal free fluid showed no significant difference between the two groups, endometrial stripe thickness was significantly higher in the unsuccessful treatment group (12.61 ± 5.79, 9.28 ± 3.53) (p = 0.002). CONCLUSIONS: In addition to the basal ß-hCG value, endometrial stripe thickness of ultrasound findings should also be considered in determining patients with a high chance of success in single-dose MTX treatment.ß-hCG changes between D0-D4 may be advantageous in the clinical management of ectopic pregnancy for earlier evaluation.

Women's voices and medical abortions: A review of the literature.

Globally, a growing proportion of induced abortions are medical abortions. The procedure has been hailed as a revolutionary technology, which, according to experts, has the potential to transform women's experiences of abortion and the way abortion services are accessed. Noticeably absent in the discourse, however, are women's voices. More specifically, there is a lack of understanding about what shapes women's preferences for medical abortion and the challenges they experience in accessing the drugs for the procedure. We conducted a systematic review of the literature to draw attention to these important issues which exist, but are often embedded within research highlighting other dominating aspects of medical abortions. A comprehensive search of four databases - supplemented by searching reference sections of selected articles, tracking their citations, and hand searching special editions on medical abortion - was conducted. A total of 45 peer-reviewed studies met our inclusion criteria. The studies were assessed for quality and analyzed using a critical interpretive synthesis approach. The findings revealed significant variations in women's preferences for surgical versus medical abortions. Country-specific abortion laws, implementing protocols, side-effects, rates of failures, and the need to verify the abortion shaped women's preference for abortion methods. Overall, women who preferred medical abortions did so because they perceived it as a 'natural' and safe procedure that can be self-conducted at home, thereby reducing their dependency on the health system. However, women face significant barriers to medical abortion care. These include legal requirements around type of provider, site of service, need for follow-up, providers' limited knowledge of the procedure, and preferences for surgical abortions. Borderless internet-based services have enabled some women to circumvent these barriers. Our review suggests that medical abortions are used by women either in countries where the health system is fully supportive or where the health system is completely disengaged, usually due to restricted abortion laws. In those countries where abortions are legal but often difficult to access due to health system barriers, women tend to prefer surgical abortions.

The "Abortion Pill" Misoprostol in Brazil: Women's Empowerment in a Conservative and Repressive Political Environment.

In the aftermath of the introduction of severe restrictions on abortion in several US states, some activists have argued that providing widespread access to an abortive drug, misoprostol, will transform an induced abortion into a fully private act and therefore will empower women. In Brazil, where abortion is criminalized, the majority of women who wish to terminate an unwanted pregnancy already use the illegal, but easily accessible, misoprostol. We examine the history of misoprostol as an abortifacient in Brazil from the late 1980s until today and the professional debates on the teratogenicity of this drug. The effects of a given pharmaceutical compound, we argue, are always articulated, elicited, and informed within dense networks of sociocultural, economic, legal, and political settings. In a conservative and repressive environment, the use of misoprostol for self-induced abortions, even when supported by formal or informal solidarity networks, is far from being a satisfactory solution to the curbing of women's reproductive rights.

Self-administered versus provider-administered medical abortion.

BACKGROUND: The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications. OBJECTIVES: To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi2 tests and I2 statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants. AUTHORS' CONCLUSIONS: This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.

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.

Management of very early medical abortion-An international survey among providers.

OBJECTIVE: To record the definition and management of Very Early Medical Abortion (VEMA) in different countries. STUDY DESIGN: An Internet survey was circulated internationally among providers of medical abortion via a website. The questionnaire focused on reasons for performing or delaying medical abortion at a very early gestational age and the perceived advantages and disadvantages of VEMA. RESULTS: Out of 220 completed questionnaires, 50 % came from European abortion providers (n = 110). Most respondents (72 %) defined VEMA as abortion performed in the presence of a positive hCG pregnancy test but with an empty uterine cavity or a gestational sac-like structure, and no signs or symptoms of ectopic pregnancy. A total of 74 % of respondents thought it was not necessary to wait for a diagnosis of intrauterine pregnancy before starting medical abortion. Equally, 74 % were aware of the possibility of an ectopic pregnancy. CONCLUSION: According to European providers of medical abortion, waiting for the diagnosis of an intrauterine pregnancy is not necessary and does not improve treatment of ectopic pregnancy. Providers should know that medical abortion can be performed effectively and safely as soon as the woman has decided. There is no lower gestational age limit.

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.