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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. [ABSTRACT FROM AUTHOR]

"Very early medical abortion" (VEMA) refers to medical abortion (with mifepristone and misoprostol) before intrauterine pregnancy is visualized on ultrasound. Our aim is to present the current evidence on efficacy, safety (focused on ectopic pregnancies), and how to assess treatment success of VEMA. We conducted a systematic review of studies reporting outcomes of VEMA. The field is small and so our objective was to map all relevant literature, without conducting meta-analysis. We searched PubMed, Medline, and Embase on April 19, 2022. We conducted a narrative synthesis of the evidence. A total of 373 articles were identified. Six articles (representing four observational and one pilot trial) were included in the final review. Across all included studies, treatment efficacy ranged between 91 and 100%. Prevalence of ectopic pregnancy was low and very few cases (n = 2) of ruptures were reported. Most studies used serial serum human chorionic gonadotrophin (s-hCG) levels to determine success of abortion; one study used low sensitivity urine hCG. From the available evidence, VEMA appears to be efficacious and does not appear to cause harm to ectopic pregnancies. Treatment can be assessed with pre- and postabortion s-hCG. Good quality, randomized controlled trial evidence is needed to best inform practice. [ABSTRACT FROM AUTHOR]

Introduction: Induced abortion is legal in Italy but with restrictions. The online abortion provider Women on Web (WoW) serves as an alternative way to access abortion. The COVID-19 pandemic has affected sexual and reproductive health worldwide. Italy was one of the first countries hit by the pandemic and imposed strict lockdown measures. We aimed to understand why women requested WoW abortion in Italy and how this was affected by the pandemic., Methods: We conducted an observational study analysing requests made to WoW before and during the pandemic. We analysed 778 requests for medical abortion from Italy between 1 March 2019 to 30 November 2020 and compared the characteristics of requests submitted before and during the pandemic. We also performed subgroup analysis on teenagers and COVID-19-specific requests., Results: There was an increase in requests during the COVID-19 pandemic compared with the previous year (12% in the first 9 months). The most common reasons for requesting a telemedicine abortion through WoW were privacy-related (40.9%); however, this shifted to COVID-19-specific (50.3%) reasons during the pandemic. Requests from teenagers (n=61) were more frequently made at later gestational stages (p=0.003), had a higher prevalence of rape (p=0.003) as the cause of unwanted pregnancies, and exhibited less access to healthcare services compared with adult women., Conclusions: There was an increase in total demand for self-managed abortion during the pandemic and reasons for requesting an abortion changed, shifting from privacy-related to COVID-19-specific reasons. This study also highlighted the uniquely vulnerable situation of teenagers with unwanted pregnancies seeking self-managed abortion., Competing Interests: Competing interests: HV has received grants/contracts from Fulbright Sweden and University of Washington. MP has received support for attending meetings/travelling from ExcelGyn and is on the International Advisory Board for ExcelGyn. KG-D has received consulting fess from Bayer, MSD, Gedeon Richter, Mithra, Exeltis, MedinCell, Cirqle, Natural Cycles, Exelgyn, Campus Pharma and HRA-Pharma. KG-D has received payments or honoraria for lectures etc. from Bayer, MSD, Gedeon Richter, Mithra, Exeltis, Exelgyn and Campus Pharma. KG-D participates in advisory boards/data and safety monitoring boards (DSMB) for Gedeon Richter and Bayer. KG-D has unpaid board memberships and similar for the International Federation of Gynecology and Obstetrics (FIGO), the World Health Organization (WHO) Department of Sexual and Reproductive Health and Research (SRH) and Human Reproduction Programme (HRP), the European Society of Contraception and Reproductive Health (ESC), the International Federation for Professionals in Abortion and Contraception (FIAPAC) and the Faculty of Sexual & Reproductive Healthcare (FSRH)/Royal College of Obstetricians & Gynaecologists in the UK. RG is the founder of Women on Web (WoW)., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)