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Self-managed abortion (SMA) refers to actions people take to end a pregnancy outside the formal health care system. There are a variety of reasons people choose to self-manage their abortions, and these reasons may vary based on regional contexts. For some people, medically delivered abortion care is no longer, or has never been, available in their community. Available options might be inaccessible or unacceptable, or the person might have a preference for self-managed care as a primary choice. The majority of SMAs are completed safely with misoprostol, either alone or with mifepristone. Rare medical complications should be managed as they would be in any case of spontaneous pregnancy loss. For many people, the greatest risk of harm related to SMA comes from the threat of criminalization. Many U.S. states have at least one law in place that could be misused to prosecute people attempting or assisting with SMA. Criminalization makes people less safe and harms the confidential patient-practitioner relationship. Obstetrician-gynecologists and other health care professionals should provide all people with compassionate, nonjudgmental medical care, including those presenting before, during, or after self-managing an abortion., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To systematically assess the safety and effectiveness of mifepristone at doses of 2.5 mg, 5 mg, 10 mg, 25 mg, and 50 mg in the treatment of uterine fibroids., Methods: The protocol is registered with INPLASY (registration number is INPLASY202460075). Computer retrieval PubMed, the Cochrane Library, Embase database related (mifepristone group) compared to placebo and mifepristone or conventional treatment (control group) in the treatment of uterine fibroids randomized controlled trial (RCT), retrieve the time limit for a Library to in October 2023, Refer to the Cochrane faced the quality evaluation of the literature of included in the 6.0 and uses the RevMan 5.4.1 software Meta-analysis and sensitivity analysis., Results: There were 18 studies with a total of 2066 patients as participants. A meta-analysis found that the patients in the mifepristone group had lower uterine volume or uterine fibroid volume than the control group, with a statistically significant difference. Mifepristone treatment for 3 months uterine volume smaller is better than 6 months the difference is statistically significant. Compared with the control group, mifepristone can improve pelvic pain, pelvic pressure, bladder pressure, urinary symptoms, lower back pain, dyspareunia, rectal pain, menorrhagia, hypermenorrhea, and other clinical symptoms. The Mifepristone group had hot flashes, endometrium thickness increases, the incidence of hepatic transaminases associated is significantly higher than the control group, the patients in the 10 mg/d mifepristone group had endometrial thickness that was greater than those in the 5 mg/d mifepristone group., Conclusions: Mifepristone reduces fibroid volume and improves clinical symptoms, and 5 mg/day of mifepristone for three months may be the optimal clinical regimen., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The World Health Organization includes oral emergency contraception (EC) in the list of essential medicines. Ulipristal acetate (UPA) and levonorgestrel (LNG) are the recommended oral methods. UPA has superior efficacy and a comparable side effect profile compared with LNG. Both work by inhibiting or delaying ovulation, so that sperm present in the reproductive tract will have lost their fertilising ability by the time the oocyte is eventually released. Neither LNG nor UPA at the EC doses have significant effects on the endometrium and are unable to prevent implantation. Mifepristone can also be used for EC but its availability is limited to few countries. LNG is less effective in women with a body mass index over 26 kg/m 2 or weight over 70 kg. Hormonal contraception can be quickstarted immediately following LNG, or five days following UPA. LNG-releasing intrauterine devices and cyclo-oxygenase inhibitors are promising options for EC to be further studied., Competing Interests: Declaration of competing interest None for all authors., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Purpose: To assess young people's interest in advance provision (AP) of medication abortion-receiving mifepristone and misoprostol from a clinician in advance for their future use., Methods: From November 2022-August 2023 we administered an electronic survey regarding advance provision to patients assigned female at birth at four Bay Area youth-serving clinics., Results: Among 152 people ages 14-24 years (mean 17.9) surveyed, 73.7% (95% CI, 65.9%-80.5%) supported and 46.1% (95% CI, 37.9%-54.3%) were interested in the AP model. AP interest was higher among people who experienced three or more difficulties trying to access reproductive healthcare (70.6% [95% CI, 44.0%-89.7%]) and who experienced food or housing insecurity (60.3% [95% CI, 46.6%-73.0%]). Most youth (81.6%) had a safe place to store the pills for later use; this proportion was significantly higher among people ages 18-24 years (88.5%) than teens ages 14-17 years (74.3%, P = .025). The most common perceived advantages of AP included being able to have the abortion earlier in pregnancy (61.8%), privacy (57.9%) and convenience (50.7%). Common disadvantages noted included concern that people might take the pills incorrectly (50.0%) or lose the pills (40.1%)., Conclusions: Young people have considerable interest in AP of medication abortion. Further research is needed to document the AP model's feasibility, clinical outcomes, and effect on access for adolescents., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: This study aimed to compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions., Study Design: We performed an unblinded, randomized, noninferiority trial of people undergoing second-trimester procedural abortion at 18 + 0 to 23 + 6 weeks' gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and preprocedural misoprostol. We powered the study on mean difference in procedure duration, a noninferiority limit of 5 minutes. We compared preprocedure cervical dilation and the need for additional dilation and, using a 100-point visual analog scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction., Results: We recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6 ± 8.9 vs Dilapan-S: 22.4 ± 12.8, p = 0.96), noninferiority was not met (mean difference, 0.2 minutes; 95% CI, -7.8 to 8.2). Cervical dilation >2 cm was more likely after Dilapan-S (100% vs 62.5%, p = 0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8 ± 1.0, Dilapan-S: 5.1 ± 2.3, p = 0.64) and maximum pain (median) with insertion (balloon 39 [5-78], Dilapan-S: 39 [0-100], p = 0.92). Pain immediately postinsertion was higher for Dilapan-S (33 [0-100] vs 18 [0-50], p = 0.046) and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p = 0.60)., Conclusion: While significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants., Implications: Clinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation., Clinical Trial Registration: ClinicalTrials.gov: NCT05099991., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic., Study Design: We conducted a prospective, non-randomized, non-inferiority cohort study across four regions in Ghana, from high-volume pharmacies and health clinics. Participants seeking medical abortion (less than nine weeks' gestation) who met usual medical abortion eligibility criteria were recruited. Data collection included baseline surveys, follow-up phone interviews, and self-reported assessments of medical abortion outcomes. The study aimed to enroll 2000 medical abortion users (1000 from each source)., Results: Complete outcome data was available and analyzed from 1958 participants (of 2208 enrolled), with the adjusted risk difference of need for additional treatment to complete the abortion indicating non-inferiority of the pharmacy group compared to the clinic group [-2.3% (95% CI -5.3% to 0.7%)]. Both groups reported low rates of additional treatment (4.9%) and adhered similarly to the abortion regimen. Secondary outcomes showed no significant differences, with moderate acceptability in both groups (65.4% pharmacy, 52.3% facility). Adverse outcomes were rare: one ectopic pregnancy, one blood transfusion and no deaths or other major complications were reported., Conclusions: Accessing medical abortion pills directly from pharmacies without prior consultation from a provider demonstrated non-inferior self-reported clinical outcomes compared to seeking care from health clinics. The findings align with the growing global evidence supporting the safety and effectiveness of medical abortion self-care., Implications: This study contributes data which support future registration of over-the-counter use of medical abortion drugs up to nine weeks' gestation. Such measures could expand options for safe abortion care, especially in regions where unsafe abortion poses a substantial maternal health risk., Trial Registration: ClinicalTrials.gov (NCT03727308)., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate medication abortion (MAB) outcomes for participants receiving intramuscular depot medroxyprogesterone acetate (DMPA) injections or subdermal etonogestrel implants concurrently with mifepristone compared to those who did not in a real-world setting., Study Design: This retrospective cohort study included MAB patients from one Planned Parenthood health center in St. Paul, MN, between 2017 and 2019. We abstracted electronic health records and compared sociodemographic variables, clinical information, and treatment failure rates (primary outcome) between study groups with logistic regression (generating odds ratios [OR] and 95% confidence intervals [CI])., Results: Among 7296 MAB participants, 224 (3.1%) received DMPA injections and 309 (4.2%) received etonogestrel implants concurrently with mifepristone; 141 (62.9%) and 200 (64.7%) completed follow-up respectively. From a random sample of 1000, 990 comparison participants met inclusion criteria; 704 (71.1%) completed follow-up. Fourteen (9.9%) DMPA participants (aOR 4.26, 95% CI 1.87-9.68, p < 0.001) and 6 (3.0%) etonogestrel implant participants (aOR 1.38, 95% CI 0.48-3.55, p = 0.522) required additional treatment to empty the uterus and/or had an ongoing pregnancy, each contrasted with 15 (2.1%) comparison patients (models adjusted for gestational duration, patient age, parity, and race)., Conclusion: Although our study is limited by high rates of loss to follow-up, our analysis suggests that concurrent administration of DMPA with mifepristone may decrease MAB efficacy, while etonogestrel implant placement does not appear to alter MAB outcomes. These findings are overall consistent with prior literature and inform post-MAB contraception counseling., Implications: This retrospective cohort study reinforces prior randomized controlled trial findings that concurrent depot medroxyprogesterone acetate injection with mifepristone administration may decrease medication abortion efficacy. Conversely, concurrent etonogestrel contraceptive implant placement with mifepristone administration does not appear to decrease medication abortion efficacy. These findings inform post-abortion contraception counseling., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: This study aimed to compare medication abortion outcomes among people screened without or with ultrasound or pelvic examination., Study Design: We used data collected from March 24, 2020, to September 27, 2021, at five TelAbortion Project sites that provided medication abortion with mifepristone and misoprostol by mail. Using logistic regression weighted on propensity scores, we compared outcomes in participants who had neither ultrasound nor examination before treatment (No-Test group) or had such tests (Test group). We analyzed outcomes separately for participants screened early in the analysis period (before September 15, 2020) or later. Outcomes included procedural abortion completion or ongoing pregnancy, serious adverse events, and unplanned posttreatment abortion-related clinical visits., Results: Among 416 participants in the early period, the No-Test group had a significantly higher risk than the Test group of procedural abortion completion or ongoing pregnancy (5.6% vs 0.9%, risk difference 4.6%, 95% CI 1.5%, 7.7%) and abortion-related clinical visits (13.3% vs 6.3%; risk difference 7.0%; 95% CI 1.1%, 12.8%). Among 364 participants screened later, the risk of procedural abortion completion or ongoing pregnancy did not differ by group, while unplanned abortion-related clinical visits were less common in the No-Test group (9.9% vs 20.5%; risk difference -10.6%; 95% CI -20.1%, -1.1%). The risk of serious adverse events did not differ by group in either period., Conclusions: When providers first began omitting ultrasound or pelvic examination before medication abortion, the practice was associated with increased risks of failure of complete abortion and posttreatment clinical visits; however, these increased risks resolved over time., Implications: Medication abortion without pretreatment ultrasound or examination is effective and safe. This model should be routinely offered to eligible patients., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Medication abortion, with a combination of mifepristone and misoprostol, is highly effective and safe. However, there is insufficient evidence on efficacy and safety at very early gestations before a pregnancy can be visualized with ultrasonography., Methods: We conducted a multicenter, noninferiority, randomized, controlled trial involving women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination (visualized as an empty cavity or a sac-like structure without a yolk sac or embryonic pole). Participants were randomly assigned to either immediate start of abortion (early-start group) or standard-care treatment delayed until intrauterine pregnancy was confirmed (standard group). The primary outcome was complete abortion. The noninferiority margin was set at 3.0 percentage points for the absolute between-group difference., Results: In total, 1504 women were included at 26 sites in nine countries and were randomly assigned to the early-start group (754 participants) or the standard group (750 participants). In an intention-to-treat analysis, a complete abortion occurred in 676 of 710 participants (95.2%) in the early-start group and in 656 of 688 (95.3%) in the standard group; the absolute between-group difference was -0.1 percentage points (95% confidence interval, -2.4 to 2.1). Ectopic pregnancies occurred in 10 of 741 participants (1.3%) in the early-start group and in 6 of 724 (0.8%) in the standard group, with one rupture before diagnosis (early-start group). Serious adverse events occurred in 12 of 737 participants (1.6%) in the early-start group and in 5 of 718 (0.7%) in the standard group (P = 0.10); the majority were uncomplicated hospitalizations for treatment of ectopic pregnancy or incomplete abortion., Conclusions: Medication abortion before confirmed intrauterine pregnancy was noninferior to standard, delayed treatment with respect to complete abortion. (Funded by the Swedish Research Council and others; VEMA EudraCT number, 2018-003675-35; ClinicalTrials.gov number, NCT03989869.)., (Copyright © 2024 Massachusetts Medical Society.)

Mifepristone is an anti-progestational drug that is the first component of the standard medical abortion regimen. For women who take mifepristone and then do not take misoprostol, which is the second component of the medical abortion regimen, it is possible that their pregnancy may continue to live birth. Since mifepristone is commonly used for medical abortion up to 9-10 weeks gestation, any adverse or teratogenic effects on the developing embryo/fetus must be considered, given exposure during the critical time of its development and organogenesis. Toxicology and teratology reports have cited studies demonstrating teratogenic effect of mifepristone in some animals. Current clinical guidelines for women exposed to mifepristone in the first trimester of pregnancy state that it is not known to be teratogenic based on limited published evidence from humans. The aim of this narrative systematic review was to investigate embryonic/fetal exposure to mifepristone and any association with congenital or fetal anomalies. This study was conducted by systematic searches of health databases from inception to February 2024. The references of relevant citations were manually searched to retrieve any additional citations not captured in database searching. Congenital anomalies and adverse outcomes were encountered at various doses of mifepristone exposure. A number of the congenital anomalies encountered in this review were explained by circumstances other than exposure to mifepristone. The present systematic review did not find data to support mifepristone being implicated as a teratogen., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Objective: To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre-treatment in-person tests in Ukraine, Uzbekistan, and Azerbaijan., Methods: We conducted an open-label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a telemedicine consultation with a study provider by phone or video. Medical abortion pills could be obtained by mail or courier or picked up at the study clinic or a pharmacy. Study providers contacted participants 1 week after mifepristone ingestion to assess abortion outcomes based on symptoms, and 3 weeks later to review the result of an at-home, high-sensitivity, urine pregnancy test. Participants were referred to in-person visit based on symptoms, urine pregnancy test results, or initiative by the participant., Results: In all, 300 women participated in the study. Almost all participants received medical abortion medications the same day as their first contact with the study clinic, and the majority (n = 297, 99.0%) did not experience any problems receiving them. All except two women (0.67%) followed provider instructions on administration of medications. The majority of participants had a complete abortion without a procedure (Ukraine: n = 115, 95.8%; Uzbekistan: n = 127, 97.7%; Azerbaijan: n = 49, 98.0%), few had in-person visits (Ukraine: n = 30, 25.0%; Uzbekistan: n = 3, 2.3%; Azerbaijan: n = 4, 8.0%), and most were very satisfied or satisfied with the service (Ukraine: n = 116, 96%; Uzbekistan: n = 128, 98%; Azerbaijan: n = 45, 90%). No serious adverse events occurred., Conclusion: Telemedicine medical abortion using the no-test protocol is safe, feasible and acceptable for women in Ukraine, Uzbekistan, and Azerbaijan., (© 2024 International Federation of Gynecology and Obstetrics.)

Importance: Medication management of early pregnancy loss (EPL), or miscarriage, typically involves the administration of misoprostol with or without pretreatment with mifepristone. Combination treatment with mifepristone plus misoprostol is more effective than misoprostol alone but is underutilized in the US., Objective: To describe differences in clinical outcomes after EPL management with mifepristone plus misoprostol vs misoprostol alone using commercial claims data., Design, Setting, and Participants: This retrospective cohort study used national insurance claims data from the IBM MarketScan Research Database. Participants included pregnant people (aged 15-49 years) with private insurance who presented with an initial EPL diagnosis between October 1, 2015, and December 31, 2022., Exposures: The primary exposure was the medication used to manage EPL (ie, mifepristone plus misoprostol or misoprostol alone). Other exposures of interest included demographic characteristics and location of service., Main Outcomes and Measures: The primary outcome was subsequent procedural management (eg, uterine aspiration) after EPL diagnosis and medication management. Other outcomes of interest included return visits, hospitalizations, and complications occurring in the subsequent 6 weeks. Descriptive statistics and bivariate analyses were used, and a multivariable logistic regression model was created to examine factors associated with subsequent procedural management., Results: This study included 31 977 patients (mean [SD] age, 32.7 [5.6] years) with claims for EPL who received medication management. Of these patients, 3.0% received mifepristone plus misoprostol and 97.0% received misoprostol alone. Patients who received misoprostol with pretreatment with mifepristone were less likely to have subsequent uterine aspiration (10.5% vs 14.0%; P = .002), and they were also less likely to have subsequent emergency department (ED) visits for EPL (3.5% vs 7.9%; P < .001). In multivariable analysis, use of mifepristone plus misoprostol was associated with decreased odds of subsequent procedural management (adjusted odds ratio, 0.71 [95% CI, 0.57-0.87])., Conclusions and Relevance: The findings of this study suggest that mifepristone is underutilized for the medication management of EPL, but its use is associated with a lower need for subsequent uterine aspiration and a decrease in the number of subsequent visits to an ED. Increasing access to mifepristone for EPL management may decrease health care utilization and expenditures.

A combination of mifepristone and a prostaglandin preparation should usually be recommended as the first-line intervention for induction of labour (Grade B). A single 200 milligram dose of mifepristone is appropriate for this indication, followed by: 24 +0 -24 +6 weeks of gestation - 400 micrograms buccal/sublingual/vaginal/oral of misoprostol every 3 hours; 25 +0 -27 +6 weeks of gestation - 200 micrograms buccal/sublingual/vaginal/oral of misoprostol every 4 hours; from 28 +0 weeks of gestation - 25-50 micrograms vaginal every 4 hours, or 50-100 micrograms oral every 2 hours [Grade C]. There is insufficient evidence available to recommend a specific regimen of misoprostol for use at more than 28 +0  weeks of gestation in women who have had a previous caesarean birth or transmural uterine scar [Grade D]. Women with more than two lower segment caesarean births or atypical scars should be advised that the safety of induction of labour is unknown [Grade D]. Staff should be educated in discussing mode of birth with bereaved parents. Vaginal birth is recommended for most women, but caesarean birth will need to be considered for some [Grade D]. A detailed informed discussion should be undertaken with parents of both physical and psychological aspects of a vaginal birth versus a caesarean birth [Grade C]. Parents should be cared for in an environment that provides adequate safety according to individual clinical circumstance, while meeting their needs to grieve and feel supported in doing so (GPP). Clinical and laboratory tests should be recommended to assess maternal wellbeing (including coagulopathy) and to determine the cause of fetal death, the chance of recurrence and possible means of avoiding future pregnancy complications [Grade D]. Parents should be advised that with full investigation (including postmortem and placental histology) a possible or probable cause can be found in up to three-quarters of late intrauterine fetal deaths [Grade B]. All parents should be offered cytogenetic testing of their baby, which should be performed after written consent is given (GPP). Parents should be advised that postmortem examination can provide information that can sometimes be crucial to the management of future pregnancy [Grade B]., (© 2024 Royal College of Obstetricians and Gynaecologists.)

Importance: In the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed., Objective: To evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall., Design, Setting, and Participants: Prospective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days' gestation, spoke English or Spanish, and were aged 15 years or older., Exposure: Study groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238)., Main Outcomes and Measures: Effectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group., Results: The mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, -4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group., Conclusions and Relevance: This prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

Objectives: This prospective single-arm study was conducted to understand the expulsion rate of the gestational sac in the management of early pregnancy loss (EPL)., Methods: We recruited 441 participants; 188 met the eligibility criteria. Participants were 18 years of age and older who experienced a confirmed EPL (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pre-treatment orally followed by 2 doses of misoprostol 800 μg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage. We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events., Results: Overall, 181 participants followed the protocol and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and 1 had an adverse event of heavy vaginal bleeding requiring dilatation and curettage. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium., Conclusions: Pretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL., (Copyright © 2024 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

In January 2023, the Food & Drug Administration modified the Risk Evaluation and Mitigation Strategy program regulating mifepristone to allow direct dispensation from retail pharmacies. In June 2023, we conducted a random, distributive survey of pharmacies in California using secret shopper methodology to investigate the feasibility of accessing mifepristone. One pharmacy had mifepristone immediately available (<24 hours), and misoprostol availability was limited. Accessibility to misoprostol varied by type of pharmacy (p < 0.01), but not by region. Even in a reproductive freedom state, access to mifepristone and misoprostol from outpatient retail pharmacies remains limited., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality., Study Design: Using a secret shopper survey, researchers attempted to contact all community pharmacies in Oregon and evaluate their mifepristone and misoprostol provisions., Results: Among the 444 pharmacies surveyed, mifepristone was planned at 19.2%. Misoprostol was available at 77.5%, but stocking issues and medication ordering impact access, without significant differences by rurality., Conclusions: Pharmacy engagement and support are key to increasing access to these essential medicines, which may be improved through education and referral programs., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: This meta-analysis aimed to comprehensively assess the teratogenic risk to offspring associated with continuing pregnancy after administering mifepristone and/or misoprostol during gestation., Methods: We conducted a systematic search of multiple databases, including PubMed, Web of Science, Embase, Cochrane, CNKI, and CBM, from their inception to February 2024, with no language restrictions. We included cohort and case-control studies that analyzed the teratogenic effects of mifepristone and/or misoprostol on fetuses and newborns. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). The odds ratios (OR) from individual studies were combined using meta-analysis. Sensitivity testing and heterogeneity analysis were conducted., Results: A total of 13 studies were eligible for inclusion, comprising 5193 cases of congenital malformations and 12,232 controls., Conclusion: Our findings indicated that the use of misoprostol during early pregnancy increased the risk of congenital abnormalities in offspring (OR = 2.69; 95% CI: 1.57-4.62). However, the potential teratogenic effect of mifepristone during pregnancy cannot be ruled out. Additionally, the use of mifepristone and/or misoprostol has been linked to a higher risk of certain congenital anomalies, such as hydrocephalus (OR = 3.41; 95% CI: 1.17-9.97), Möbius syndrome (OR = 26.48; 95% CI: 11.30-62.01), and terminal transverse limb defects (OR = 10.75; 95% CI: 3.93-29.41). (PROSPERO, CRD42024522093, 03182024)., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Medical abortion after 12 gestational weeks often requires a stay in hospital. We hypothesised that administering the first misoprostol dose at home could increase day-care procedures as compared with overnight care procedures, shorten inpatient stays, and improve patient satisfaction., Methods: This multicentre, open-label, randomised controlled trial was done at six hospitals in Sweden. Participants were pregnant people aged 18 years and older who were undergoing medical abortion at 85-153 days of pregnancy. Randomisation was done in blocks 1:1 to mifepristone administered in-clinic followed by home administration or hospital administration of the first dose of misoprostol. Allocation was done by opening of opaque allocation envelopes. Due to the nature of the intervention, masking was not feasible. Between 24-48 h after mifepristone 200 mg, the participants administered 800 μg of misoprostol either at home 2 h before admission to hospital or in hospital. The primary outcome was the proportion of day-care procedures (defined as abortion completed in <9 h). The intention-to-treat analysis included all participants randomly assigned to receive the study drug and who had known results for the primary outcome. Individuals who received any treatment were included in the safety analyses. This trial is registered at ClinicalTrials.gov, NTC03600857, and EudraCT, 2018-000964-27., Findings: Between Jan 8, 2019, and Dec 21, 2022, 457 participants were randomly assigned to treatment groups. In the intention-to-treat-population, 220 participants were assigned to the home group and 215 to the hospital group. In the home group, 156 (71%) of 220 participants completed the abortion as day-care patients, compared with 99 (46%) of 215 in the hospital group (difference 24·9%, 95% CI 15·4-34·3; p<0·0001). In total, 97 (22%) of 444 participants in the safety analysis had an adverse event. Seven (2%) of 444 participants aborted after mifepristone only. Two (1%) of 220 in the home group aborted after the first dose of misoprostol, before hospital admission., Interpretation: Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, offering a safe and effective alternative to in-clinic protocols., Funding: Region Västra Götaland, Hjalmar Svensson's Fund, the Gothenburg Society of Medicine, Karolinska Institutet-Region Stockholm, and The Swedish Research Council., Competing Interests: Declaration of interests KG-D reports honoraria for ad hoc lectures or participation on advisory boards from Bayer, Organon/MSD, Gedeon Richter, Mithra, Natural Cycles, MedinCell, Ferring, Norgene, Exelgyn, Exeltis, Cirqle, RemovAid, and Obseva. HK-K reports honoraria for lectures, participation in courses, or acting as principal investigator in trials from AbbVie, Actavis, Bayer, Gedeon Richter Exeltis, Nordic Pharma, Natural Cycles, Mithra, Teva, Merck, Organon, Ferring, Consilient Health, Evolan, Natural Cycles, Pharmiva, Dynamic Code, Ellen, Estercare, Pharmiva, Gedea, Gesynta, Essity, Preglife, and Takeda. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

According to this study., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: The objective of our study was to identify and characterize barriers to mifepristone use among obstetrician-gynecologists (OB-GYNs) for early pregnancy loss in a southern US state., Methods: In this qualitative study, we conducted semistructured interviews with 19 OB-GYNs in Alabama who manage early pregnancy loss. The interviews explored participants' knowledge of and experience with mifepristone use for miscarriage management and abortion, along with barriers to and facilitators of clinical mifepristone use. The interviews were coded by multiple study staff using inductive and deductive thematic coding., Results: Nearly all of the interviewees identified abortion-related stigma as a barrier to mifepristone use. Interviewees often attributed stigma to a lack of knowledge about the clinical use of mifepristone for early pregnancy loss. The stigmatization of mifepristone due to its association with abortion was related to religious and political objections. Many interviewees also described stigma associated with misoprostol use. Although providers believed that mifepristone use for abortion would not be accepted in their practice, most believed that mifepristone could be used successfully for miscarriage management after practice-wide education on its use., Conclusions: Mifepristone is strongly associated with abortion stigma among OB-GYNs in Alabama, which is a barrier to its use for miscarriage management. Interventions to decrease abortion stigma and associated stigma surrounding mifepristone are needed to optimize early pregnancy loss care.

Objectives: To evaluate the implementation of mifepristone and misoprostol for medical management of early pregnancy loss (EPL) in emergency departments (EDs) by comparing efficacy, complication, and follow-up rates for patients treated in EDs to the Complex Family Planning (CFP) outpatient office., Study Design: In COVID-19's first wave, we expanded medical management of EPL to our EDs. This retrospective study evaluated 72 patients receiving mifepristone and misoprostol for EPL from April 1, 2020 to March 31, 2021, comparing treatment success, safety outcomes, and follow-up rates by location., Results: Thirty-three (46%) patients received care in the ED and 39 (54%) at CFP. Treatment success was lower in EDs (23, 70%) compared to CFP (34, 87%), but after adjusting for insurance status and pregnancy type (miscarriage, uncertain viability, unknown location), this was not significant: adjusted odds ratio 0.48 (95% CI 0.13-1.81). More ED patients underwent emergent interventions (3 vs 0) including two emergent uterine aspirations, one uterine artery embolization, and two blood transfusions. Two cases were attributed to misdiagnosis (cesarean scar and cervical ectopic pregnancies interpreted as incomplete miscarriages) and one to guideline nonadherence. No complications occurred in the CFP group. Follow-up rates were over 80% in both groups. More ED patients engaged in telehealth follow-up (67% vs 18%, p ≤ 0.0001)., Conclusions: In this small sample, we observed a trend toward less successful treatment in the ED compared to the CFP office. Both correctly making uncommon diagnoses and adhering to new guidelines presented implementation challenges., Implications: Implementing mifepristone and misoprostol for EPL in our EDs achieved lower rates of pregnancy resolution compared to outpatient management. Complex uncommon diagnoses and implementing new care pathways in EDs may have contributed to complications and highlighted opportunities for improvement. Additional studies are needed to further quantify safety outcomes for EPL management in EDs., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Importance: Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion., Objective: To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy., Design, Setting, and Participants: This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023., Intervention: Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person., Main Outcomes and Measures: Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications., Results: Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing., Conclusions and Relevance: The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.

Purpose: To summarize evidence on levonorgestrel releasing intrauterine system (LNG-IUS) in the treatment of adenomyosis (AM) and to identify potential research gaps., Methods: Search was conducted in MEDLINE, The Cochrane Library, EMBASE, CBM, CNKI, and Wanfang. We included studies investigating patients with AM treated with LNG-IUS combined with conservative therapy., Results: Thirty-nine studies compared LNG-IUS with other conservative therapeutic drugs. The most common comparison was GnRH-a + LNG-IUS vs. LNG-IUS alone, followed by LNG-IUS vs. mifepristone, expected treatment, and GnRH-a. GnRH-a + LNG-IUS was more beneficial in reducing the intensity of dysmenorrhea than LNG-IUS alone at the 6-month follow-up in patients with an enlarged uterus and moderate to severe dysmenorrhea. Large and well-designed studies are needed to confirm the efficacy of LNG-IUS and GnRH-a on reducing uterine volume at 6-month follow-up. Thirty-two studies investigated LNG-IUS as the postoperative management. The most common comparison was surgical excision + LNG-IUS vs. surgical excision. Results showed VAS scores were lower in the surgical excision + LNG-IUS group than in the surgical excision group at the 1-year follow-up. Evidence on endometrial thickness, quality of life, adverse events and beneficial effect at 3 and 5 years are needed., Conclusions: Combined GnRH-a and LNG-IUS treatment was more efficacious than LNG-IUS alone for patients with an enlarged uterus and moderate to severe dysmenorrhea. Moreover, LNG-IUS seemed to show potential long-term benefits in postoperative therapy, warranting further meta-analysis for confirmation., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion., Methods: We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens., Results: Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively ( P =.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively ( P <.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion ( P =.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion ( P =.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups., Conclusion: A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester., Clinical Trial Registration: ClinicalTrials.gov, NCT04160221., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest. Paul D. Blumenthal indicated that mifepristone is commonly used off label for cervical preparation in second-trimester abortion procedures., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: To what extent traditional Chinese medicine (TCM) combined with mifepristone and misoprostol is beneficial for improving the complete abortion rate and duration of vaginal bleeding has been a subject of debate in the field of medical abortion., Objective: To assess the evidence regarding the complete abortion rate and duration of vaginal bleeding of medical abortion assisted by different kinds of TCM., Search Strategy: We searched electronic databases such as PubMed, Web of Science and Cochrane Library database, China National Knowledge Internet, Wan fang Database, VIP Database, and China Biology Medicine disc from 2000 to February 15, 2023., Selection Criteria: The control group was medical abortion with mifepristone and misoprostol, and the experimental group was medical abortion assisted by TCM., Data Collection and Analysis: Major data extraction included sample size, age, medicine used for abortion, outcome measures. RevMan 5.3 and Stata 15.1 software were used to assess the literature quality and perform network meta-analysis, respectively., Main Results: A total of 73 randomized controlled trials (RCTs) with 11 683 patients and nine kinds of TCM were included in this study. Compared with mifepristone and misoprostol, eight kinds of TCM had statistical significance in improving the complete abortion rate. The effect value of Sancao decoction was 5.86 (95% confidence interval [CI] 2.53-13.58). Seven kinds of TCM shortened the duration of vaginal bleeding. The effect value of comfrey and trichosanthin decoction was -8.75 (95% CI -10.86 to -6.64)., Conclusions: This network meta-analysis showed that Lenge Zhumo decoction and Sancao decoction could have a large beneficial effect on complete abortion rate in medical abortion during early pregnancy, and comfrey and trichosanthin decoction could be the best TCM for shortening the duration of vaginal bleeding., (© 2023 International Federation of Gynecology and Obstetrics.)

Background: Despite their importance in reducing maternal mortality, information on access to Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region is limited., Methods: A standardized assessment tool measuring access to Mifepristone, Misoprostol, and contraceptive medicines included in the WHO essential medicines list (EML) was implemented in eight countries in the Eastern Mediterranean Region (Afghanistan, Iraq, Lebanon, Libya, Morocco, Palestine, Pakistan, and Somalia) between 2020-2021. The assessment focused on five access measures: 1) the inclusion of medicines in national family planning guidelines; 2) inclusion of medicines in comprehensive abortion care guidelines; 3) inclusion of medicines on national essential medicines lists; 4) medicines registration; and 5) procurement and forecasting of Mifepristone, Misoprostol, and contraceptive medicines. A descriptive analysis of findings from these eight national assessments was conducted., Results: Only Lebanon and Pakistan included all 12 contraceptives that are enlisted in the WHO-EML within their national family planning guidelines. Only Afghanistan and Lebanon included mifepristone and mifepristone-misoprostol combination in post-abortion care guidelines, but these medicines were not included in their national EMLs. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs-and registered-in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan). However, only three countries procured misoprostol (Iraq, Morocco, and Somalia)., Conclusion: These findings can guide efforts aimed at improving the availability of Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region. Opportunities include expanding national EMLs to include more options for Mifepristone, Misoprostol, and contraceptive medicines and strengthening the registration and procurement systems to ensure these medicines' availability were permitted under national law and where culturally acceptable., (© 2024. The Author(s).)

AbstractWith recent severe restrictions to abortion accessibility in the United States and a pending Supreme Court case challenging the Food and Drug Administration's approval of mifepristone, evidence-based strategies to protect and expand access to abortion care are needed. Two safe and effective regimens for medication abortion are widely used globally - misoprostol-only and misoprostol in combination with mifepristone. However, misoprostol-only regimens are rarely used in the United States. In 2023, the National Abortion Federation and the Society of Family Planning updated their recommended protocol for misoprostol-only for medication abortion to 800 μg of misoprostol administered buccally, sublingually, or vaginally every 3 hours for three or more doses. To characterize the data supporting this specific regimen, this article reviews the relevant literature to address the question of how effective misoprostol-only is for medication abortion. The authors conclude that the updated misoprostol regimen is highly effective and a potential strategy for expanding access to abortion.

Objectives: To evaluate the safety and efficacy of first-trimester "No Touch" medication abortion programs at 2 clinics in Toronto, Ontario during their early implementation in response to the COVID-19 pandemic., Methods: This retrospective study included all patients who underwent virtual consultation for mifepristone-misoprostol medication abortion between April 2020-August 2022 at 2 reproductive health clinics. In response to the pandemic, "No Touch" abortion protocols have been developed that align with the Canadian Protocol for the Provision of Medical Abortion via Telemedicine. Records were reviewed for demographic information, clinical course, investigations required, confirmation of complete abortion and adverse events. The primary outcome was complete medication abortion, defined as expulsion of the pregnancy without requiring uterine aspiration., Results: A total of 277 patients had abortions initiated in the "No Touch" or "Low Touch" care pathways and had sufficient follow-up to determine outcomes. Of these patients, 92.8% (95% CI 89.7%-95.8%) had a complete medication abortion (n = 257) and 76.1% (n = 159) remained "No Touch" throughout their care. Investigations were performed for 102 participants before or after their abortion, classifying them as "Low Touch". Nineteen patients (6.9%) underwent uterine aspiration. The rate of adverse events was low, with 1 case of a missed ectopic pregnancy and 1 patient requiring hospitalization for endometritis., Conclusions: "No Touch" provision of mifepristone-misoprostol medication abortion care was safe and effective with outcomes comparable to previous studies. These results provide evidence for the efficacy and safety of a "No Touch" approach in the Canadian context, which has the potential to reduce barriers to accessing abortion care., (Copyright © 2024 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Objectives: In November 2022, the anti-abortion advocacy group Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication's safety record. Such challenges relied on a study examining the incidence of emergency room visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999-2015. In February 2024 that study was retracted by its publisher. In this paper, we analyzed the methods and presentations of the data used in the study., Study Design: We drew upon commonly accepted principles in responsible epidemiologic and scientific research to evaluate the methods and presentations of the data and organized our findings into themes., Results: We found multiple instances of methodological flaws, mischaracterizations, and obfuscations of data in this study, including use of a misleading research question and framing, analytic flaws, inappropriate use of an unvalidated proxy measure for outcomes of interest, and inappropriate and deceptive visualizations of data. In each instance, the resulting effect obfuscated and misrepresented the safety of medication abortion with mifepristone., Conclusions: The misrepresentation and exaggeration of data promoted and exacerbated misinterpretations about the study's findings, resulting in substantial harm before it was retracted. Recognizing that ongoing judicial proceedings threaten access to conventional reproductive health care in the United States, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations., Implications: Studnicki et al.'s study of emergency room visits after abortion misrepresented the safety of mifepristone with multiple instances of methodological flaws and obfuscations of data. While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion, which has an established safety record., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who conceived without medical assistance and those who conceived through in vitro fertilization (IVF), after fresh or frozen embryo transfer, and evaluate for the predictive factors of success, time to first passage of tissue, and time to complete resolution of pregnancy., Design: Retrospective cohort study., Setting: University hospital., Patient(s): Women who presented with EPL below 13 weeks of gestation between June 2013 and July 2021 who were managed medically with mifepristone 200 mg orally and misoprostol 800 mcg vaginally were included in the study., Intervention(s): Medical management with mifepristone and misoprostol; conception without medical assistance vs. post-IVF, after fresh or frozen embryo transfer., Main Outcome Measure(s): We evaluated overall success and performed subgroup analysis according to the mode of conception and compared fresh vs. frozen-thawed embryo transfers for IVF pregnancies. In all groups, we also calculated success according to gestational age and compared the time to first passage of tissue. The potential predictive factors of treatment success were analyzed. The side effects and complications of treatment were recorded., Result(s): A total of 930 women were included in the study, 99 (11%) of whom achieved pregnancy after IVF. The overall success of medical treatment was 89% with no statistically significant difference according to the mode of conception (89% vs. 89%) or type of transfer (fresh 89% vs. frozen 89%). Only lower gestational age by sonography was independently predictive of treatment success, showing a negative regression coefficient of β = -0.333 and an odds ratio of 0.717. The mean time to first passage of tissue was 5.0 ± 2.1 hours. Altogether, 666 women (72%) showed pregnancy resolution on the day of medication administration, an additional 110 women at 1-week follow-up, and a further 74 women after ≥4 weeks on ultrasound., Conclusion(s): Medical management of EPL with mifepristone and misoprostol is a highly successful treatment option that results in completed abortion in a timely fashion in both pregnancies conceived without medical assistance and those conceived after IVF., Competing Interests: Declaration of interests V.C.-T. has nothing to disclose. M.H. has nothing to disclose. A.C.-K. has nothing to disclose. M.T. has nothing to disclose. S.M. has nothing to disclose. B.T. has nothing to disclose. B.S. has nothing to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper., (Copyright © 2024 by the National Legal Center for the Medically Dependent and Disabled, Inc.)

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., Competing Interests: Conflict of interest: Emily Godfrey is an Organon Nexplanon Trainer, but this interest is outside the scope of the submitted work. None of the other authors have conflicting and competing interests to disclose., (© Copyright 2024 by the American Board of Family Medicine.)

Objective: To assess the risk difference of uterine rupture when using current mifepristone and misoprostol regimens for second-trimester abortion among individuals with prior cesarean birth compared with those without prior cesarean birth., Data Sources: We searched the terms second trimester, induction, mifepristone, and abortion in PubMed, EMBASE, POPLINE, ClinicalTrials.gov , and Cochrane Library from inception until December 2022., Methods of Study Selection: We included randomized trials and observational studies including a mixed cohort, with and without uterine scar, of individuals at 14-28 weeks of gestation who used mifepristone and misoprostol to end a pregnancy or to manage a fetal death. We excluded case reports, narrative reviews, and studies not published in English. Two reviewers independently screened studies., Tabulation, Integration, and Results: Absolute risks with binomial CIs were calculated from pooled data. Using R software, we estimated total risk difference by the Mantel-Haenszel random-effects method without continuity correction. For studies with zero events, a continuity correction of 0.5 was applied for individual risk differences and plotted graphically with forest plots. Statistical heterogeneity was assessed with Higgins I2 statistics. Funnel plot assessed for publication bias. Of 198 articles identified, 22 met the inclusion criteria: seven randomized trials (n=923) and 15 observational studies (n=6,195). Uterine rupture risk with prior cesarean birth was 1.1% (10/874) (95% CI 0.6-2.1) and without prior cesarean birth was 0.01% (2/6,244) (95% CI 0.0-0.12). The risk difference was 1.23% (95% CI 0.46-2.00, I2 =0%). Of the 12 reported uterine ruptures, three resulted in hysterectomy., Conclusion: Uterine rupture with mifepristone and misoprostol use during second-trimester induction abortion is rare, with the risk increased to 1% in individuals with prior cesarean birth., Systematic Review Registration: PROSPERO, CRD42022302626., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background Second-trimester abortions, constitute 10-15% of global annual abortions, leading to two-thirds of major abortion-related complications. Recognizing the elevated risk, the WHO recommends diverse methods for safe termination. Surgical and medical approaches, particularly using drugs like Mifepristone and Misoprostol, show promising success rates. Objective To analyze the outcomes of second-trimester termination using Mifepristone or PG analogues alone or in combination. Method This is a one-year retrospective study at Tribhuvan University Teaching Hospital analyzing second-trimester terminations, collecting data on demographics, medical history, period of gestation, doses of abotificient drugs, complications, and management. Result In a study of 66 second-trimester abortions, mean age was 28.8±4.96 years, gestational age 20.07±4.3 weeks. Mifepristone and Misoprostol combination succeeded in 66.7% of cases, while 42.2% required repeated Mifepristone doses. Misoprostol use was significantly higher in patients without medical comorbidities (p=0.018), but Mifepristone requirement didn't differ significantly based on medical conditions. Combined Mifepristone and Misoprostol were used more for fetal indications. Notably, the use of Mifepristone and Misoprostol didn't significantly differ for live and intrauterine fetal death cases. Conclusion Mifepristone and Misoprostol effectively terminate second-trimester pregnancies. In high-risk cases, cautious Prostaglandin use is crucial and Mifepristone alone, in divided doses, reduces complications with high success.

Background: In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL., Methods and Findings: A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups., Conclusion: The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management., Competing Interests: The authors have declared that no competing interests exist.

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., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Ethnopharmacological Relevance: Uterine leiomyoma (UL) is a common severe gynecological issue. In China, Xuefu Zhuyu Decoction (XFZYD), combined with Mifepristone, is widely used in the treatment of UL. However, their combined effectiveness and safety for this purpose have not yet been explored., Aim of the Study: This systematic review aims to evaluate the effectiveness and safety of XFZYD combined with Mifepristone as a method of treatment for UL., Materials and Methods: We searched the following 7 databases: 3 English medical databases (PubMed, EMBASE, Cochrane Library), and 4 Chinese medical databases (Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and the Wanfang database). The primary outcome was the effect of XFZYD combined with Mifepristone on the effective rate, uterine leiomyoma volume (ULV), and uterine volume (UV) of uterine leiomyoma. Bias risk was assessed using the Cochrane risk of bias tool. The software RevMan5 was used to evaluate the quality of the included studies and process the data., Results: The 11 studies included in this systematic review were all undertaken in China, with a total of 902 participants. The meta-analysis of XFZYD combined with Mifepristone compared with Mifepristone alone showed that the effective rate (RR 1.20, 95% confidence interval (CI): 1.14-1.27, P < 0.00001), ULV (SMD -1.60, 95% CI: 2.11 to -1.08, P < 0.00001), and UV (SMD -1.65, 95% CI: 1.85 to -1.44, P < 0.00001) in the primary outcomes, and estradiol (E2) (MD -51.81, 95% CI: 69.68 to -33.94, P < 0.00001), luteinizing hormone (LH) (MD -3.09, 95% CI: 3.58 to -2.60, P < 0.00001), follicle stimulating hormone (FSH) (MD -1.09, 95% CI: 1.86 to -0.31, P = 0.006), progesterone (P) (MD -3.55, 95% CI: 4.54 to -2.55, P < 0.00001), and adverse events (RR 0.55, 95% CI: 0.34-0.89), P = 0.01) in the secondary outcomes were significantly reduced, and the data were statistically significant. The subgroups of ULV, E2, and FSH showed that the treatment time might not have been the heterogeneous source of ULV and FSH, but was the heterogeneous source of E2. Sensitivity analysis was carried out on the 3 outcome indicators, and the results were relatively stable after excluding one reference for each indicator., Conclusion: There is some encouraging evidence that the combination of XFZYD and Mifepristone can benefit patients by treating UL. However, because of research shortcomings such as lacking allocation concealment and blindness, this study's results should be treated with caution. In order to verify the advantages of this method, it is necessary to carry out further large-scale randomized controlled trials., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Uterine fibroids are benign. They belong to the category of "abdominal mass" in traditional Chinese medicine, and pathogenesis is mainly caused by weakness of the body, qi stagnation, and blood stasis. Drug therapy is the preferred treatment of uterine fibroids in clinical practice, and mifepristone is the most commonly used drug. In the past decade, a large number of clinical randomized controlled trials have proven that Chinese patent medicine combined with mifepristone in the treatment of uterine fibroids has a better curative effect, fewer adverse reactions, and higher safety than mifepristone alone. However, there is a lack of evidence-based research. This study aims to integrate clinical data through network meta-analysis to provide more evidence-based medical evidence for clinical medication., Methods: The comprehensive search included Chinese and other-language databases, such as MEDLINE (PubMed), Web of Science, The Cochrane Library, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, China Scientific Journal Database, and China Biomedical Literature Database. Clinical randomized controlled trials of 6 Chinese patent medicines combined with mifepristone for the treatment of uterine fibroids, including Guizhi Fuling Capsule, Gongliuxiao Capsule, Gongliuqing Capsule, Danbie Capsule, Gongliuning Capsule, and Xiaojiean Capsule were retrieved. The search period was from January 2010 to April 2021. Two researchers screened the literature through EndNote and used Excel to extract data. RevMan 5.3 was used to evaluate the quality of the literature. Treatment measures were analyzed in R language, and a forest map and probability ranking map of various interventions were drawn. The network evidence map and correction comparison funnel map of various interventions were drawn by STATA 14.0 software., Results: This study provides the clinical efficacy and safety of network meta-analysis of 6 kinds of Chinese patent medicines combined with mifepristone in the treatment of uterine fibroids will be systematically evaluated or descriptively analyzed., Conclusion: This study's purpose is to provide a reference for the clinical treatment of uterine fibroids to choose more effective intervention therapies., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

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&#95;crh @edinuniusher., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Since Canadian drug regulatory approval of mifepristone for medical abortion in 2015 and its market availability in January 2017, the role of pharmacists in abortion provision has changed rapidly. We sought to identify the factors that influenced the initiation and provision of medical abortion from the perspectives of Canadian pharmacists, bridging two frameworks - Diffusion of Innovation in Health Service Organizations and integrated knowledge translation., Methods: We conducted one-on-one semi-structured interviews with pharmacists residing in Canada who intended to stock and dispense mifepristone within the first year of availability. Our data collection, analysis, and interpretation were guided by reflexive thematic analysis and supported by an integrated knowledge translation partnership with pharmacy stakeholders., Results: We completed interviews with 24 participants from across Canada: 33% had stocked and 21% had dispensed mifepristone. We found that pharmacists were willing and able to integrate medical abortion care into their practice and that those who had initiated practice were satisfied with their dispensing experience. Our analysis indicated that several key Diffusion of Innovation constructs impacted the uptake of mifepristone, including: innovation (relative advantage, complexity and compatibility, technical support), system readiness (innovation-system fit, dedicated time, resources), diffusion and dissemination (expert opinion, boundary spanners, champions, social networks, peer opinions), implementation (external collaboration), and linkage. Participants' experiences suggest that integrated knowledge translation facilitated evidence-based changes to mifepristone dispensing restrictions, and communication of those changes to front line pharmacists., Conclusions: We illustrate how Diffusion of Innovation and integrated knowledge translation may work together as complimentary frameworks for implementation science research. Unlike in the USA, UK, and other highly regulated settings globally, pharmacists in Canada are permitted to dispense mifepristone for medical abortion. We contribute to literature that shows that mifepristone dispensed outside of hospitals, clinics, and medical offices is safe and acceptable to both patients and prescribers. This finding is of particular importance to the current COVID-19 pandemic response and calls for continued and equitable access to abortion care in primary practice., (© 2021. The Author(s).)

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., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)