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Evidence-based guidelines on the management of pain associated with first-trimester medical abortion are lacking. Most published clinical trials have failed to report on this important aspect of the procedure. The aim of this comprehensive work was to provide clinical advice based on a comprehensive literature review, supplemented by the clinical experience of a group of European experts in case no evidence is available. Pain level ranged from 5 to 8 in 80% of studies where pain was measured on a 0-10 visual analogue scale; severe pain was reported by 20-80% of women. Pain assessment was rarely reported in studies. Pain treatment should be preventive and avoidance of unnecessary uterine contractions should be considered. Analgesic treatment should follow the WHO three-step ladder, starting with the use of NSAIDs and allowing for easily available back-up treatment with weak opioids. [ABSTRACT FROM AUTHOR]

Competing Interests: Competing interests: The authors declare no competing interests.

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.)

Objective: The Parliamentary Assembly invited the member states of the Council of Europe to 'guarantee women's effective exercise of their right of access to a safe and legal abortion'. While abortion legislation and statistics give an impression of the legislative, cultural, and religious views of the societies and the socio-economic health of the female population, only one study conducted in 2011 looked into the current legislation and trends in terminations of pregnancy in the European Union. Materials and Methods: From January 2017 to December 2018, a group of experts, the authors of the present article, liaised with colleagues practising in 32 European countries to collect data on abortion legislation and statistics using three different questionnaires. Results: The article presents the results of this initiative and compares the status quo and recent trends in abortion legislation and statistics across Europe. Conclusions: The European legislations are still very heterogenous and abortion rates vary widely between countries, confirming that laws do not correlate with abortion rates. This compilation of data, also available on a website (www.abort-report.eu), may help to change laws to better meet the needs of women who decided to have an abortion as a solution to the underlying problem of an unwanted pregnancy.

Objective: To record the definition and management of Very Early Medical Abortion (VEMA) in different countries., Study Design: An Internet survey was circulated internationally among providers of medical abortion via a website. The questionnaire focused on reasons for performing or delaying medical abortion at a very early gestational age and the perceived advantages and disadvantages of VEMA., Results: Out of 220 completed questionnaires, 50 % came from European abortion providers (n = 110). Most respondents (72 %) defined VEMA as abortion performed in the presence of a positive hCG pregnancy test but with an empty uterine cavity or a gestational sac-like structure, and no signs or symptoms of ectopic pregnancy. A total of 74 % of respondents thought it was not necessary to wait for a diagnosis of intrauterine pregnancy before starting medical abortion. Equally, 74 % were aware of the possibility of an ectopic pregnancy., Conclusion: According to European providers of medical abortion, waiting for the diagnosis of an intrauterine pregnancy is not necessary and does not improve treatment of ectopic pregnancy. Providers should know that medical abortion can be performed effectively and safely as soon as the woman has decided. There is no lower gestational age limit., Competing Interests: Declaration of Competing Interest The authors were all members of the external scientific advisory board of Exelgyn at the time of this study. Christian Fiala has served on an ad hoc basis as an invited lecturer for Exelgyn. Aubert Agostini is a board member at Nordic Pharma and MSD, and an investigator for some Nordic Pharma studies. Teresa Bombas is a member of advisory boards for Merck and HRA, has an occasional consultancy relationship with Exelgyn and Nordic, and is a speaker at conferences/symposiums organized by Bayer, Merck, HRA, Gedeon, and Exelgyn. Roberto Lertxundi has a financial relationship (member of advisory boards, lecturer, and/or consultant) with Exelgyn, Nordic-Pharma, Exeltis, Bayer-Pharma, and Teva. Marek Lubusky has an occasional consultancy relationship with Exelgyn and Nordic. Mirella Parachini has an occasional consultancy relationship with Exelgyn and Nordic. Kristina Gemzell-Danielsson has served on an ad hoc basis as an invited lecturer for Exelgyn, Line Pharma, and Gynuity, and as an investigator in clinical trials conducted by Concept Foundation/SunPharma. Laurence Saya is an employee of Altius Pharma CS, and as such was indirectly paid by Exelgyn for help in medical writing., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objective: Medical termination of pregnancy (MToP, or medical abortion) is a highly effective method with a reported efficacy of 95-98%. However, different criteria are currently used to define success, and there are different recommendations for the treatment of what is considered a failure of MToP. This work was undertaken to develop a consensus around a set of well-defined MToP outcomes, as recommended by the Core Outcomes in Women's and Newborn Health initiative., Methods: A literature search was made of national and international guidelines and of recommendations of expert groups for various outcomes of MToP and subsequent management. Based on a review of the findings, a group of European experts in MToP undertook a consensus process to agree on a set of core MToP outcomes., Results: The following core MToP outcomes were defined: success, failure (ongoing pregnancy), need for additional treatment (medical or surgical) to complete MToP (missed abortion, incomplete abortion), complications and the woman's request for additional treatment (medical or surgical). Recommendations for the management of unsuccessful outcomes were also formulated., Conclusion: New definitions of MToP outcomes that are more focused on objective criteria and consequently less dependent on provider interpretation are proposed. This should allow better comparison of the efficacy of different regimens and improve the management of failed or incomplete abortion.

Objectives: although some degree of pain is inevitable with first trimester medical abortion, little information is available regarding its management in daily practice. The aim of the work was to determine the current regimens in use for managing pain associated with medical abortion., Study Design: a self-administered internet survey, developed by a group of European experts on medical abortion, was circulated internationally among medical abortion providers., Results: A total of 283 valid questionnaires were completed, mainly from European providers (59% of respondents, n = 167). Most respondents (n = 267, 94%) reported analgesic prescription/provision for all women, either prophylaxic for 82% (n = 233) or upon request for 12% (n = 34). WHO Step I analgesics (NSAIDs, paracetamol) were the most often used in both cases. A total of 16 (6%) respondents indicated that they never provided analgesics (or prescriptions for them). Female providers of abortion care were significantly more likely to prescribe systematic analgesia for patients than male providers (85% vs 74%, p < 0.04). The majority of respondents (69%, n = 195) did not conduct formal assessments of women's pain., Conclusion: Most providers do provide analgesia routinely to women undergoing medical abortion up to 9 weeks gestation. There were widespread variations in analgesic regimens used. There is a clear need for standardised evidence based regimens for management of pain associated with first trimester medical abortion., (Copyright © 2018 Elsevier B.V. All rights reserved.)

After an analysis of the history of the introduction of the so called "abortion pill" in various countries included Italy, it is analyzed the substantial differences between the two procedures of medical abortion comparing with surgical abortion.

Introduction: Misoprostol (Cytotec) is recognised to be effective for many gynaecological indications including termination of pregnancy, management of miscarriage and postpartum haemorrhage. Although not licensed for such indications, it has been used for these purposes by millions of women throughout the world. Misoprostol tablets are most often packaged as multiple tablets within an aluminium strip, each within an individual alveolus. When an alveolus is opened, tablets will be exposed to atmospheric conditions., Objective: To compare the pharmaco technical characteristics (weight, friability), water content, misoprostol content and decomposition product content (type A misoprostol, type B misoprostol and 8-epi misoprostol) of misoprostol tablets Cytotec (Pfizer) exposed to air for periods of 1 hour to 720 hours (30 days), to those of identical non exposed tablets., Methods: Four hundred and twenty (420) tablets of Cytotec (Pfizer) were removed from their alveoli blister and stored at 25°C/60% relative humidity. Water content, and misoprostol degradation products were assayed in tablets exposed from 1 to 720 hours (30 days). Comparison was made with control tablets (N=60) from the same batch stored in non-damaged blisters. Statistical analyses were carried out using Fisher's exact test for small sample sizes., Results: By 48 hours, exposed tablets demonstrated increased weight (+4.5%), friability (+1 300%), and water content (+80%) compared to controls. Exposed tablets also exhibited a decrease in Cytotec active ingredient dosage (-5.1% after 48 hours) and an increase in the inactive degradation products (+25% for type B, +50% for type A and +11% for 8-epi misoprostol after 48 hours) compared to controls., Conclusion: Exposure of Cytotec tablets to 'typical' European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets.

Objectives: To evaluate pain and other early adverse events associated with different regimens of medical abortion up to nine weeks of amenorrhoea., Methods: The literature was searched for comparative studies of medical abortion using mifepristone followed by the prostaglandin analogue misoprostol. Publications, which included pain assessment were further analysed., Results: Of the 1459 publications on medical abortion identified, only 23 comparative, prospective trials corresponded to the inclusion criteria. Patients in these studies received different dosages of mifepristone in combination with different dosages of misoprostol administered via diverse routes or at various intervals. Information on pain level was reported in 12/23 papers (52%), information regarding systematic administration of analgesics in 12/23 articles (52%) and information concerning analgesia used was available for only 10/23 studies (43%)., Conclusions: Neither pain nor its treatment are systematically reported in clinical trials of medical abortion; this shortcoming reflects a neglect of the individual pain perception. When data are mentioned, they are too inconsistent to allow for any comparison between different treatment protocols. Standardised evaluation of pain is needed and the correlation between the dosage of misoprostol and the intensity of pain must be assessed in future studies.

Objective: Demand for second-trimester induced abortions (STIAs) increases in Italy. For these procedures, prostaglandins alone were used until 2010, when mifepristone became available. The present study compares the two modalities, and investigates the reasons for STIAs., Methods: The records of all such procedures performed at the Department of Gynaecology, Obstetrics and Urology of the 'Sapienza' University (Rome), between January 2004 and December 2012, and of all those done at the 'San Filippo' Hospital (Rome), between January 2010 and December 2012, were analysed. Data gathered included women's age, obstetric history, reasons for requesting the STIA, gestational age, mode of intervention, and complications if any., Results: During the study period, 353 women requested a STIA. Karyotype or genetic anomalies were the reason for the request in 187 cases (53%), while structural anomalies, both single and multiple, were given as the reason in 158 (45%). In most cases, these anomalies were assessed by ultrasound scan., Conclusion: Few studies have investigated reasons for requesting STIAs. Of all chromosome abnormalities diagnosed in this study, trisomy 21 was the most common (59%) and it was the most frequent reason for requesting pregnancy termination.