OBJECTIVE: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov (NCT03727308).

OBJECTIVE: 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.
CONCLUSIONS: 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).

BACKGROUND: Effective pain management during labor induction for pregnancy termination is essential. However, to date, no effective treatment has been identified. The primary aim of this study was to measure the analgesic efficacy of a sufentanil sublingual tablet system during pregnancy termination and patient satisfaction by comparing nulliparous and multiparous women. The secondary aims were to characterize the safety profile by reporting any side effects or adverse events and to determine the need for rescue therapy.
METHODS: We conducted an observational, retrospective, single-center study involving 48 women. The data retrieved for analysis included the total and hourly doses of sublingual sufentanil, evaluations of pain management satisfaction using a 5-point rating scale (ranging from 1, indicating \"not satisfied\" to 5, denoting \"completely satisfied\"), occurrence of side effects and adverse events, and the rate of rescue analgesic use. Categorical and numerical variables were compared between the two groups, and a correlation analysis was performed.
RESULTS: The median total dose of sufentanil required was 60 mcg. Nulliparous women required a higher dose of sufentanil compared with multiparous women (105 mcg vs. 45 mcg; P = 0.01). Additionally, they underwent a longer labor, indirectly measured by the time of device usage (625 min vs. 165 min; P = 0.05). Regarding satisfaction, 40 patients (83.4%) were satisfied or completely satisfied, whereas only 8 patients (16.6%) reported dissatisfaction. Multiparous women exhibited higher satisfaction levels than did nulliparous women (P = 0.03). No adverse events were reported, and the most common side effects were nausea and vomiting (31.2%). Four patients (12%) required acetaminophen due to insufficient analgesia, with only one patient necessitating a switch to intravenous morphine.
CONCLUSIONS: Sublingual sufentanil was effective in both nulliparous and multiparous women with minimal side effects. Therefore, sublingual sufentanil can be considered a valid strategy for analgesia during labor induction for pregnancy termination.

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.
CONCLUSIONS: Telemedicine medical abortion using the no-test protocol is safe, feasible and acceptable for women in Ukraine, Uzbekistan, and Azerbaijan.

BACKGROUND: In 2019, the World Health Organization identified improving access to safe abortion as an important priority toward improving sexual and reproductive health and rights and achieving Sustainable Development Goals. One strategy for addressing this priority is strengthening access to medicines for medical abortion. All 11 countries in the South-East Asia Region have some indications for legal abortion and permit post-abortion care. Therefore, strengthening access to medical abortion medicines is a reasonable strategy for improving access to safe abortion for the Region.
METHODS: We applied an adapted version of an existing World Health Organization landscape assessment protocol for the availability of medical abortion medicines at the country-level in the South-East Asia Region. We collected publicly available data on the existence of national health laws, policies, and standard treatment guidelines; inclusion of medical abortion medicines in the national essential medicines list; and marketing authorization status for medical abortion medicines for each country and verified by Ministries of health. The findings were once more presented, discussed and recommendations were formulated during regional technical consultation workshop. Each country teams participated in the process, and subsequently, the suggestions were validated by representatives from Ministries of Health..
RESULTS: Few countries in the Region currently have national policies and guidelines for comprehensive safe abortion. However, either mifepristone-misoprostol in combination or misoprostol alone (for other indications) is included in national essential medicines lists in all countries except Indonesia and Sri Lanka. Few countries earmark specific public funds for procuring and distributing medical abortion commodities. In countries where abortion is legal, the private sector and NGOs support access to medical abortion information and medicines. Several countries only allow registered medical practitioners or specialists to administer medical abortion.
CONCLUSIONS: Following this rapid participatory assessment and technical consultation workshop, the World Health Organization South-East Asia Regional Technical Advisory and Sexual and Reproductive Health and Rights technical committee recommended priority actions for policy and advocacy, service delivery, and monitoring and evaluation, and indicated areas for support.

Abortion (also known as termination of pregnancy) is an essential element of women\'s reproductive health care. Feedback from women who underwent medical termination of pregnancy about their experience is crucial to help practitioners identify women\'s needs and develop necessary tools to improve the abortion care process. However, the collection of this feedback is quite challenging. Social media offer anonymity for women who share their abortion experience.
This exploratory infodemiology study aimed to analyze, through French social media posts, personal medical symptoms and the different experiences and information dynamics associated with the medical abortion process.
A retrospective study was performed by analyzing posts geolocated in France and published from January 1, 2017, to November 30, 2021. Posts were extracted from all French-language general and specialized publicly available web forums using specific keywords. Extracted messages were cleaned and pseudonymized. Automatic natural language processing methods were used to identify posts from women having experienced medical abortion. Biterm topic modeling was used to identify the main discussion themes and the Medical Dictionary for Regulatory Activities was used to identify medical terms. Encountered difficulties were explored using qualitative research methods until the saturation of concepts was reached.
Analysis of 5398 identified posts (3409 users) led to the identification of 9 major topics: personal experience (n=2413 posts, 44.7%), community support (n=1058, 19.6%), pain and bleeding (n=797, 14.8%), psychological experience (n=760, 14.1%), questioned efficacy (n=410, 7.6%), social pressure (n=373, 6.9%), positive experiences (n=257, 4.8%), menstrual cycle disorders (n=107, 2%), and reported inefficacy (n=104, 1.9%). Pain, which was mentioned in 1627 (30.1%) of the 5398 posts by 1024 (30.0%) of the 3409 users, was the most frequently reported medical term. Pain was considered severe to unbearable in 24.5% of the cases (399 of the 1627 posts). Lack of information was the most frequently reported difficulty during and after the process.
Our findings suggest that French women used social media to share their experiences, offer and find support, and provide and receive information regarding medical abortion. Infodemiology appears to be a useful tool to obtain women\'s feedback, therefore offering the opportunity to enhance care in women undergoing medical abortion.

OBJECTIVE: To determine whether clinical outcomes among clients undergoing medical abortion after 12 weeks\' gestation differ by provider cadre.
METHODS: Randomized controlled trial conducted among eligible clients seeking abortion between 13 and 20 weeks\' gestation. Participants seeking in-facility abortion were randomized to receive care from a mid-level provider (nurse/midwife) or physician. The primary outcome was median time to expulsion with non-inferiority margin of -1.5 h between provider groups. Quantile median regression models assessed non-inferiority. Secondary outcomes included retained placenta, complications, and patient acceptability.
RESULTS: After randomization and eligibility assessment by the provider, 171 women participated in the study: 81 in the physician group and 90 in the mid-level provider group. Their average age was 24 years, the mean gestational age was 16 weeks, and 65% were nulliparous in both groups. The median time to expulsion did not differ significantly, being 8.1 h for the mid-level group and 6.6 h for the physician group. The adjusted median difference was 0.8 h (95% confidence interval [CI] -1.15 to 2.66), within the non-inferiority margin. Retained placenta occurred similarly: 30.0% (n = 24) of the physician group and 20.5% (n = 18) of the mid-level provider group (adjusted risk difference [ARD] 7.6%, 95% CI -2.81 to 18.06). Complications occurred in 7% of cases, including 5.0% (n = 4) of patients in the physician group and 8.9% (n = 8) in the mid-level provider group (ARD -4.7%, 95% CI -12.43 to 3.12). Patient acceptability did not differ by group.
CONCLUSIONS: Training mid-level providers to provide abortion services after 12 weeks\' gestation independently of physicians is feasible and may result in comparable clinical outcomes.

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.
METHODS: 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.
METHODS: The control group was medical abortion with mifepristone and misoprostol, and the experimental group was medical abortion assisted by TCM.
METHODS: 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.
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.

OBJECTIVE: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC).
METHODS: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone.
RESULTS: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found.
CONCLUSIONS: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues.

The COVID-19 pandemic impacted comprehensive abortion care provision. To maintain access to services while keeping individuals safe from infection, many organisations adapted their programmes. We conducted a programme evaluation to examine service adaptations implemented in Bolivia, Mali, Nepal, and the occupied Palestinian territory. Our programme evaluation used a case study approach to explore four programme adaptations through 14 group and individual interviews among 16 service providers, facility managers and representatives from supporting organisations. Data collection took place between October 2021 and January 2022. We identified adaptations to comprehensive abortion care services in relation to provision, health information systems and counselling, and referrals. Four overarching strategies emerged: (1) the use of digital technologies, (2) home and community outreach, (3) health worker optimisation, and (4) further consideration of groups in vulnerable situations. In Bolivia, the use of a messaging application increased access to confidential gender-based violence support and comprehensive abortion care. In Mali, the adoption of digital approaches created timely and complete data reporting and trained members of the community served as \"interlocutors\" between the communities and providers. In Nepal, an interim law expanded medical abortion provision to pharmacies, and home visits complemented facility-based services. In the occupied Palestinian territory, the use of a hotline and social media expanded access to quick and reliable information, counselling, referrals, and post-abortion care. Adaptations to comprehensive abortion care service delivery to mitigate disruptions to services during the COVID-19 pandemic may continue to benefit service quality of care, access to care, routine monitoring, as well as inclusivity and communication in the longer term.