Medical abortion : improving access and care from very early pregnancy to the second trimester

INTRODUCTION: Medical abortion with mifepristone and misoprostol is a safe and effective treatment. Removing unnecessary barriers to treatment increases access and improves health and wellbeing. Since the introduction of medical abortion, treatment has been simplified, allowing women to self-manage the treatment at home in the first trimester. Telemedicine provision can further increase access to safe abortion, but randomized trials from high income settings are lacking. Additionally, there is insufficient evidence on efficacy of medical abortion in very early gestation, before a pregnancy can be visualized on ultrasound. This leads to inconsistencies in treatment recommendations, and for some women abortion is delayed. For women seeking abortion in the second trimester, it is recommended that the procedure is performed in a health care facility, due to the increased risk of complications. This can create a barrier to treatment. Optimizing the protocol to include administration of misoprostol at home before hospital admission, could shorten the time spent in hospital. This can improve access by increasing number of patients managed with a day-care procedure.

AIM: The overall aim of this thesis is to improve access to medical abortion by finding evidence for further de-medicalizing of treatment in first and second trimester and expanding access to treatment in very early gestation.

METHOD: We conducted 3 randomized trials and 1 observational, cross-sectional study. In study I patients seeking abortion before 6 weeks of gestation with an unconfirmed intra-uterine pregnancy (IUP) was randomized to immediate or standard delayed care after 7-14 days (at confirmed IUP). In study III women seeking abortion up to 9 weeks of gestation, were randomized at the telephone booking to an online consultation or standard in-clinic provision of abortion. In study IV patients seeking abortion in the second trimester were randomized to home initiation of misoprostol before hospital admission or hospital administration. In study II we analyzed requests for telemedicine abortion (using the same online consultation from Study III) in Italy before and during the pandemic.

RESULTS: We could show a non-inferiority of efficacy compared to standard care for both very early medical abortion (95.2% vs 95.3%) (study I) and after telemedicine consultation (98.2% vs 98.1%) (study III). We could also show that home initiation of misoprostol in second trimester abortion resulted in more patients being completed as day-care patients (71% vs 46%)(study IV). All interventions had similar safety outcomes as standard care. In study II we could show a 12% increase in requests for telemedicine abortion during the pandemic and that reasons for seeking an abortion were mainly related to need for privacy and due to the pandemic.

CONCLUSION: Offering treatment in very early gestation before confirmed IUP is effective and safe. Telemedicine abortion is effective and safe, and there is a need for alternative provision also in settings with legal abortion. Home initiation of misoprostol in seconds trimester abortion is safe and increases number of patients being treated with a day-care procedure.

List of scientific papers

I. Randomized Trial of Very Early Medication Abortion. Brandell K, Jar-Allah T, Reynolds-Wright J, Kopp Kallner H, Hognert H, Gyllenberg F, Kaislasuo J, Tamang A, Tuladhar H, Boerma C, Schimanski K, Gibson G, Løkeland M, Teleman P, Bixo M, Mandrup Kjaer M, Kallfa E, Bring J, Heikinheimo O, Cameron S, Gemzell- Danielsson K; VEMA (Very Early Medication Abortion) Study Group. New England Journal of Medicine. 2024 Nov 7;391(18):1685-1695. https://doi.org/10.1056/nejmoa2401646

II. Telemedicine as an alternative way to access abortion in Italy and characteristics of requests during the COVID-19 pandemic. Brandell K, Vanbenschoten H, Parachini M, Gomperts R, Gemzell- Danielsson K. BMJ Sexual & Reproductive Health. 2022 Oct;48(4):252-258. https://doi.org/10.1136/bmjsrh-2021-201281

III. A Randomized Trial on Efficacy of Telemedicine Abortion. Isabella Bizjak*, Karin Brandell*, Ninni Mannerberg, Anette Aronsson, Amanda Cleeve & Kristina Gemzell Danielsson. [Manuscript]

IV. First dose of misoprostol administration at home or in hospital for medical abortion between 12-22 gestational weeks in Sweden (PRIMA): a multicentre, open-label, randomised controlled trial. Rydelius J, Hognert H, Kopp-Kallner H, Brandell K, Romell J, Zetterström K, Teleman P, Gemzell-Danielsson K. Lancet. 2024 Aug; 404(10455):864-873. https://doi.org/10.1016/s0140-6736(24)01079-1

*Shared first author