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

<p dir="ltr">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.</p><p dir="ltr">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.</p><p dir="ltr">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.</p><p dir="ltr">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.</p><p dir="ltr">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.</p><h3>List of scientific papers</h3><p dir="ltr">I. Randomized Trial of Very Early Medication Abortion. <b>Brandell K,</b> 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. <a href="https://doi.org/10.1056/nejmoa2401646" rel="noreferrer" target="_blank">https://doi.org/10.1056/nejmoa2401646</a></p><p dir="ltr">II. Telemedicine as an alternative way to access abortion in Italy and characteristics of requests during the COVID-19 pandemic. <b>Brandell K,</b> Vanbenschoten H, Parachini M, Gomperts R, Gemzell- Danielsson K. BMJ Sexual & Reproductive Health. 2022 Oct;48(4):252-258. <a href="https://doi.org/10.1136/bmjsrh-2021-201281" rel="noreferrer" target="_blank">https://doi.org/10.1136/bmjsrh-2021-201281</a></p><p dir="ltr">III. A Randomized Trial on Efficacy of Telemedicine Abortion. Isabella Bizjak*, Karin Brandell*, Ninni Mannerberg, Anette Aronsson, Amanda Cleeve & Kristina Gemzell Danielsson. [Manuscript]</p><p dir="ltr">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, <b>Brandell K,</b> Romell J, Zetterström K, Teleman P, Gemzell-Danielsson K. Lancet. 2024 Aug; 404(10455):864-873. <a href="https://doi.org/10.1016/s0140-6736(24)01079-1" rel="noreferrer" target="_blank">https://doi.org/10.1016/s0140-6736(24)01079-1</a></p><p dir="ltr">*Shared first author</p>

Commentary: No-test medication abortion: A sample protocol for increasing access during a pandemic and beyond

Medical abortion reporting of efficacy: the MARE guidelines

<p dir="ltr">Introduction: Contraceptive prevention is a key factor to avoid an unintended pregnancy. Several studies have shown that an increased uptake of Long-Acting Reversible Contraceptive methods (LARCs) reduce unintended pregnancies and abortions. LARCs are the most effective methods, as they are not user- dependent, compared to short-acting methods. Surveys show that women in Sweden consider effectiveness as the most important factor when choosing a contraceptive. However, use of less effective methods is often seen. In comparison to similar European countries, abortion rates in Sweden are among the highest and the unmet need of contraception in Sweden 17.2%.</p><p dir="ltr">Contraceptive counselling can facilitate prevention, although consistent and clear recommendations on how to provide counselling is lacking. Medical treatment with mifepristone and misoprostol for medical abortion is effective and safe. Treatment can be self-managed at home in the first trimester. However, clear evidence is lacking on very early medical abortion (VEMA) before a pregnancy is confirmed on ultrasound. Abortion providers may therefore delay care until a pregnancy is visualized. Telemedicine abortion provides a way to reduce barriers and expand access to safe abortion care, however there are no randomized trials from high income settings.</p><p dir="ltr">Aim: The overall aim of this thesis is to provide evidence on models that can contribute to expanded access to medical abortion in very early gestation (before confirmed intrauterine pregnancy) and following telemedicine consultation. In addition we aimed to evaluate if a structured contraceptive counselling model can increase women's use of highly effective contraceptive methods.</p><p dir="ltr">Method: We conducted one retrospective cohort study and two randomized trials. In study I the efficacy of abortion was retrospectively evaluated in patients seeking medical abortion with an unconfirmed intra-uterine pregnancy (IUP) compared to women with confirmed IUP. In study II women seeking care at abortion clinics, youth or maternal health clinics were randomized to structured contraceptive counselling (SCC) or contraceptive counselling according to routine (i.e no clear/specified structure) to evaluate the effect on LARC uptake and continuation. In study III patients seeking early medical abortion (<9weeks) were randomized at the phone booking to an online consultation or standard in- clinic care.</p><p dir="ltr">Results: Study I showed no significant difference in abortion efficacy after VEMA compared to standard care (efficacy 98.2 vs 97.1%) No difference was seen in ongoing pregnancies, and interventions (additional misoprostol and surgical aspiration) for incomplete abortion was significantly less after VEMA. In Study II LARC uptake increased after SCC and LARC use was higher at 12 months follow- up compared to those who received routine counselling. At abortion clinics, at 12 months, pregnancy rates were significantly lower after receiving SCC. Among women initiating a LARC method no effect on continuation rates could be seen between groups at the 12 month follow-up. In study III telemedicine consultation was non-inferior to standard medical abortion care (98.2 vs 98.2%). Conclusion:</p><p dir="ltr">Medical abortion treatment before confirmed IUP is effective and safe and should be offered to patients seeking abortion in very early gestation. The risk for ectopic pregnancy needs to be acknowledged, therefore a structured clinical protocol should be implemented if VEMA is offered. Structured contraceptive counselling provides a valuable tool in increasing the uptake of LARC methods and reduce unintended pregnancies. Telemedicine abortion is an effective and safe alternative to standard in-clinic care.</p><h3>List of scientific papers</h3><p dir="ltr">I. Efficacy and safety of very early medical termination of pregnancy: a cohort study <b>Bizjak I,</b> Fiala C, Berggren L, Hognert H, Sääv I, Bring J, Gemzell- Danielsson K. BJOG. 2017 Dec;124(13):1993-1999<br><a href="https://doi.org/10.1111/1471-0528.14904" rel="noreferrer" target="_blank">https://doi.org/10.1111/1471-0528.14904<br><br></a></p><p dir="ltr">II. Increasing uptake of long-acting reversible contraception with structured contraceptive counselling: cluster randomized controlled trial (the LOWE trial) Emtell Iwarsson K*, Envall N*, <b>Bizjak I,</b> Bring J, Kopp Kallner H, Gemzell-Danielsson K. BJOG. 2021 Aug;128(9):1546-1554<br><a href="https://doi.org/10.1111/1471-0528.16754" rel="noreferrer" target="_blank">https://doi.org/10.1111/1471-0528.16754<br><br></a></p><p dir="ltr">III. Contraceptive uptake and compliance after structured contraceptive counselling - secondary outcomes of the LOWE trial <b>Bizjak I,</b> Envall N, Emtell Iwarsson K, Kopp Kallner H, Gemzell- Danielsson K. Acta Obstet Gynecol Scand. 2024 May;103(5):873-883.<br><a href="https://doi.org/10.1111/aogs.14792" rel="noreferrer" target="_blank">https://doi.org/10.1111/aogs.14792<br><br></a></p><p dir="ltr">IV. A Randomized Trial on Efficacy of Telemedicine Abortion <b>Isabella Bizjak</b>*, Karin Brandell*, Ninni Mannerberg, Anette Aronsson, Amanda Cleeve & Kristina Gemzell Danielsson. [Manuscript]</p><p dir="ltr">*Shared first author</p>

<p dir="ltr">Introduction: Contraceptive prevention is a key factor to avoid an unintended pregnancy. Several studies have shown that an increased uptake of Long-Acting Reversible Contraceptive methods (LARCs) reduce unintended pregnancies and abortions. LARCs are the most effective methods, as they are not user- dependent, compared to short-acting methods. Surveys show that women in Sweden consider effectiveness as the most important factor when choosing a contraceptive. However, use of less effective methods is often seen. In comparison to similar European countries, abortion rates in Sweden are among the highest and the unmet need of contraception in Sweden 17.2%.</p><p dir="ltr">Contraceptive counselling can facilitate prevention, although consistent and clear recommendations on how to provide counselling is lacking. Medical treatment with mifepristone and misoprostol for medical abortion is effective and safe. Treatment can be self-managed at home in the first trimester. However, clear evidence is lacking on very early medical abortion (VEMA) before a pregnancy is confirmed on ultrasound. Abortion providers may therefore delay care until a pregnancy is visualized. Telemedicine abortion provides a way to reduce barriers and expand access to safe abortion care, however there are no randomized trials from high income settings.</p><p dir="ltr">Aim: The overall aim of this thesis is to provide evidence on models that can contribute to expanded access to medical abortion in very early gestation (before confirmed intrauterine pregnancy) and following telemedicine consultation. In addition we aimed to evaluate if a structured contraceptive counselling model can increase women's use of highly effective contraceptive methods.</p><p dir="ltr">Method: We conducted one retrospective cohort study and two randomized trials. In study I the efficacy of abortion was retrospectively evaluated in patients seeking medical abortion with an unconfirmed intra-uterine pregnancy (IUP) compared to women with confirmed IUP. In study II women seeking care at abortion clinics, youth or maternal health clinics were randomized to structured contraceptive counselling (SCC) or contraceptive counselling according to routine (i.e no clear/specified structure) to evaluate the effect on LARC uptake and continuation. In study III patients seeking early medical abortion (<9weeks) were randomized at the phone booking to an online consultation or standard in- clinic care.</p><p dir="ltr">Results: Study I showed no significant difference in abortion efficacy after VEMA compared to standard care (efficacy 98.2 vs 97.1%) No difference was seen in ongoing pregnancies, and interventions (additional misoprostol and surgical aspiration) for incomplete abortion was significantly less after VEMA. In Study II LARC uptake increased after SCC and LARC use was higher at 12 months follow- up compared to those who received routine counselling. At abortion clinics, at 12 months, pregnancy rates were significantly lower after receiving SCC. Among women initiating a LARC method no effect on continuation rates could be seen between groups at the 12 month follow-up. In study III telemedicine consultation was non-inferior to standard medical abortion care (98.2 vs 98.2%). Conclusion:</p><p dir="ltr">Medical abortion treatment before confirmed IUP is effective and safe and should be offered to patients seeking abortion in very early gestation. The risk for ectopic pregnancy needs to be acknowledged, therefore a structured clinical protocol should be implemented if VEMA is offered. Structured contraceptive counselling provides a valuable tool in increasing the uptake of LARC methods and reduce unintended pregnancies. Telemedicine abortion is an effective and safe alternative to standard in-clinic care.</p><h3>List of scientific papers</h3><p dir="ltr">I. Efficacy and safety of very early medical termination of pregnancy: a cohort study <b>Bizjak I,</b> Fiala C, Berggren L, Hognert H, Sääv I, Bring J, Gemzell- Danielsson K. BJOG. 2017 Dec;124(13):1993-1999<br><a href="https://doi.org/10.1111/1471-0528.14904" rel="noreferrer" target="_blank">https://doi.org/10.1111/1471-0528.14904<br><br></a></p><p dir="ltr">II. Increasing uptake of long-acting reversible contraception with structured contraceptive counselling: cluster randomized controlled trial (the LOWE trial) Emtell Iwarsson K*, Envall N*, <b>Bizjak I,</b> Bring J, Kopp Kallner H, Gemzell-Danielsson K. BJOG. 2021 Aug;128(9):1546-1554<br><a href="https://doi.org/10.1111/1471-0528.16754" rel="noreferrer" target="_blank">https://doi.org/10.1111/1471-0528.16754<br><br></a></p><p dir="ltr">III. Contraceptive uptake and compliance after structured contraceptive counselling - secondary outcomes of the LOWE trial <b>Bizjak I,</b> Envall N, Emtell Iwarsson K, Kopp Kallner H, Gemzell- Danielsson K. Acta Obstet Gynecol Scand. 2024 May;103(5):873-883.<br><a href="https://doi.org/10.1111/aogs.14792" rel="noreferrer" target="_blank">https://doi.org/10.1111/aogs.14792<br><br></a></p><p dir="ltr">IV. A Randomized Trial on Efficacy of Telemedicine Abortion <b>Isabella Bizjak</b>*, Karin Brandell*, Ninni Mannerberg, Anette Aronsson, Amanda Cleeve & Kristina Gemzell Danielsson. [Manuscript]</p><p dir="ltr">*Shared first author</p>

Federal, state, and institutional barriers to the expansion of medication and telemedicine abortion services in Ohio, Kentucky, and West Virginia during the COVID-19 pandemic

In this chapter, we consider the wider context of abortion care from a medical perspective. To do so, we explain various commonly practiced abortion methods. This is to situate early medical abortion within the range of available options—particularly in relation to surgical methods—and to aid in an understanding of how early medical abortion might map onto a telemedical care pathway. In discussing early medical abortion, we also detail the distinction between medical abortion and early medical abortion. We also examine the evidence regarding the safety, effectiveness, and acceptability of early medical abortion. Aside from clinical indications, we highlight why a person may prefer one method of abortion over another, particularly in terms of convenience and side effects. We demonstrate that whilst (early) medical abortion is preferable to many, there are important reasons why surgical methods might be chosen by some, and we must not disregard the value of these preferences.

Introduction: The D Antigen is a specific red blood cell surface protein. Its presence (RhD pos) or absence (RhD neg) is genetically predetermined. In regard to the field of obstetrics, the antigen absence on the mother`s red blood cells is a matter of concern once such a woman becomes pregnant with an RhD pos. fetus as rhesus incompatibility would take place. Once an RhD neg. woman gives birth or undergoes an invasive procedure such as abortion, post-sensitization could happen because D Antigen development takes 35 to 45 days after conception. Even early abortion that takes place up to the 8th week of the pregnancy, involves the risk of unpredictable onset of an alloimmunization process leading to complications in future pregnancies. Materials and Methods: We have conducted a literature review using database sources including AccessMedicine, PubMed and ScienceDirect. Conflicting evidences were found among a limited number of researches. Consultation with the British Pregnancy Advisory Service took place in order to learn about present practices. Results: From 2 up to 5 percent of RhD neg. women could produce antibodies as a response to fetal RhD pos. cells entering maternal circulation and not develop alloimmunization reaction in early medical abortion. Small number of studies support that administration of anti-D immunoglobulin (Ig) after abortion leads to decreased alloimmunization development with few side effects. So far, there are no longitudinal studies that would prove the beneficial effect of anti-D Ig administration after early medical abortion. Conclusion: The administration of anti-D Ig in RhD neg. women undergoing abortion with RhD pos. fetus is still a subject of debate and demands further investigation. Therefore, doctors have to follow their country guidelines, which vary substantially. For example, the United States suggest prophylactic anti-D administration after 12 weeks of gestation whereas in the United Kingdom it is recommended to give anti-D antigen to every non-sensitized RhD neg. woman after medical abortion regardless of the duration of gestation.

Medical abortion is fundamental to women's health care. It provides a safe and effective alternative to early surgical abortion and can occur in the privacy of a woman's home. Compared to European countries and the United States (US), access to medical abortion in Australia has been a recent development, as prior to 2013 use of mifepristone was severely restricted and only available under the Authorised Prescriber provisions of the Therapeutic Goods Act 1989 to the few clinicians who applied for it.1 In 2015 a composite pack of mifepristone and misoprostol, sponsored by MS Health, a subsidiary of Marie Stopes International (MSI), became available for use up to 63 days gestation. The study by Goldstone et al.2 in this issue of ANZJOG, documents the recent clinical experience of 15 008 Australian women who sought abortion up to a gestation of 63 days and received the regimen of 200 mg of oral mifepristone followed 24–48 h later by 800 μg misoprostol self-administered buccally at home. This followed a previous study by the same lead author which detailed the outcomes of 13 345 early medical abortions between 2009 and 2011.3 The combined regimen of mifepristone, followed 36–48 h later by the prostaglandin E1 analogue misoprostol, is now well established as both safe and effective for gestations up to 63 days and the Goldstone paper adds to the extensive international evidence. Studies on the use of mifepristone in over 400 000 women have reported that the rates of serious adverse events, including hospital admission, blood transfusion, or significant infection, range from 0.01 to 0.7%, and that these events are almost always treatable without long-term sequelae.4, 5 Common side effects such as bleeding, cramping, fever and chills are generally minor and transitory.5 There have been a small number of deaths worldwide attributable to the use of mifepristone related to post-abortion sepsis with a rare organism, Clostridium sordellii.6 While not diminishing the significance of these deaths, the mortality risk for both medical and surgical abortion is substantially lower than continuing a pregnancy to term.7 The Goldstone study is one of the largest published cohorts and confirms previous findings with high method success (95.16%), low rates of infection (0.11%) or haemorrhage requiring transfusion (0.13%). No link could be confirmed between the one death that occurred as a result of Streptococcal pyogenes-related necrotising pneumonia and mifepristone administration. In countries where mifepristone has been available for some time, around half of all women choose medical over surgical abortion and the few randomised trials that have been undertaken show comparable acceptability of both methods.8 Irrespective of whether misoprostol (following mifespristone administration) is administered in a public hospital/clinic or in a private setting,9 most international studies report that around 90% of women who undergo medical abortion would, if required, choose the method again or would recommend it to a friend.10 Overall acceptability varies with parity (lower in nulliparous than in parous women), gestational age (reduces as gestational age increases) and according to the amount of pain and bleeding experienced.11, 12 Despite the fact that abortion is one of the most commonly performed gynaecological procedures in Australia and that approximately one in four women will have an abortion in their lifetime,13 the availability of medical abortion in Australia, however positive a development, has not reduced some of the barriers to access faced by many women. As a result of law reform in six of eight Australian jurisdictions, abortion can be performed lawfully subject to various conditions in these jurisdictions but it has been fully decriminalised only in the Australian Capital Territory. Abortion remains a crime in New South Wales (NSW) and Queensland and can only be performed lawfully at all as a result of case law permitting abortion where it is necessary to prevent serious risk to the life or health of the woman. Australian research has consistently indicated that 70–80% of the public support a woman's right to access abortion and believe it should be lawful.14, 15 Practitioners report that the current complex and varied legal status of abortion across Australia has a significant impact on service provision and compromises patient care.16, 17 Regardless of legal status and public opinion, access in most states and territories is complicated by the costs of largely private provision and lack of access for women in rural regions where few private services operate. Women are often required to pay for the costs of an abortion ‘upfront’ and if they live at a distance which necessitates extensive travel and an overnight stay near the abortion clinic, costs can be prohibitive.18 Of the 80 000 estimated abortions in Australia each year, most occur in the private sector.18-20 In several states, including the most populous state of NSW, public access to abortion is extremely limited. Public hospitals have abrogated responsibility for abortion service provision, leaving the private sector, including independent abortion clinics and a small number of motivated general practitioners (GPs), to fill the need. Although private services provide high-quality medical care, they can be costly and out of financial reach for some women. While costs vary, particularly with the introduction of newer services, a recent study of women attending a service provider reported the median out of pocket cost for a medical abortion as $560 and more than two-thirds (68.1%) of women had to rely on financial assistance from two or more sources.18 Compared to women from urban areas, women who had to travel for four or more hours to a city-based clinic were significantly more likely to present later than nine weeks gestation which made them more often ineligible to choose medical abortion. This group of women were also more likely to identify as Aboriginal and/or Torres Strait Islander, report less knowledge of medical abortion and have greater difficulty paying for the procedure. These results indicate that the potential for medical abortion to improve equitable access to abortion services will remain limited unless geographical, knowledge and financial impediments to obtaining early care are reduced.18 Many of these barriers that leave some women without the means to terminate an unwanted pregnancy could be addressed through medicare funded access to both medical and surgical abortion through the public hospital system. Nevertheless, other service delivery models within the Australian setting need consideration. Private provision through dedicated clinics can remain an option, but primary care services delivered through general practice, family planning clinics and sexual health services ought to be enhanced. It was hoped that with subsidy of mifepristone and misoprostol through the Pharmaceutical Benefits Scheme in 2013, coupled with the provision of accredited online training for GPs in the delivery of medical abortion, that improvements in access, especially for women in rural areas, would occur through GP provision. However, uptake in general practice appears to be low with a recent NSW-based qualitative study suggesting reasons for this ranging from from the belief that medical abortion is beyond the scope of general practice, to fears of community stigma and the perception that provision is complicated.21 While medical abortion will not be within the scope of all GP practices, support by local gynaecologists and hospital services for those who do want to provide this service is imperative in the event that specialist back-up is required. Other innovations include the availability in most states and territories of telemedicine medical abortion services. One of the first, The Tabbot Foundation, underwent a recent independent review. The results presented at the 15th World Congress on Public Health in Melbourne found it to be a safe and effective service.22 Since its establishment in 2015, mifepristone and misoprostol have been sent through the post to over 1800 women following a referral for an ultrasound and blood tests and a telephone assessment consultation. Follow-up to confirm abortion completion involves a blood test but, as mentioned in the paper by Goldstone et al., the use of a home-based semi-quantitative urine pregnancy test shows promise in reducing the need for women to return to the clinic to confirm successful treatment. This, together with the use of remote access communication technologies, is ideally suited to the Australian context where repeat clinic visits can be challenging but follow-up is required. While implementation of evidence-based clinical and service delivery innovations are imperative, promoting a workforce that is competent and willing to provide abortion is even more fundamental.23 Early exposure to each component necessary to support women in controlling their fertility should begin in medical school and continue through to specialist gynaecology training, as well as general practice and other relevant disciplines. All gynaecologists and GPs, regardless of whether they personally choose to provide abortion services, should have skills in supporting informed decision-making about pregnancy options, knowledge about medical and surgical abortion and skills or rapid referral pathways for the provision of effective contraception, including post-abortion long acting reversible contraception (LARC) to prevent repeat unwanted conceptions. Only then will abortion service provision become normalised as an essential component of women's health care in Australia.24 Globally, many would be aware that the Trump administration in the United States has issued an executive order that restricts funding to international organisations that provide women in low and middle income countries with information about their reproductive health rights and options. The policy requires non-governmental organisations receiving federal funding to agree to ‘neither perform nor actively promote abortion as a method of family planning in other nations’. This will potentially see many organisations forfeiting federal funding from the US, the largest contributor to global health funds, for crucial reproductive health care as well as non-abortion-related health initiatives.25 Within the US, the Trump government is also planning to defund Planned Parenthood which provides contraceptive advice and abortion to millions of women across the country. In Australia threats to severely restrict access to abortion are unlikely in the current climate, but as a nation we continue to fail to address the issue of equity of access to one of the most common procedures women will require in their lifetime. The public health system in a number of states has neglected management of unintended pregnancy and provision of abortion procedures. In countries where women can elect either medical or surgical abortion, around 50% choose the former, whereas currently only a third of Australian women take up this option. This may be due to several reasons, including the relative recency of its introduction, a lack of community or even medical practitioner awareness and knowledge about medical abortion and current clinical guidelines for follow-up care requiring a repeat clinic visit. Studies such as the one by Goldstone et al. have been essential in documenting the uptake, safety and efficacy of medical abortion in Australia and are crucial in helping women make informed choices when faced with an unintended pregnancy, and in equipping healthcare providers to support women in their choice. But more needs to be done to ensure that our health system does not fail to provide the basic services which every woman has a right to access, regardless of her financial circumstances or where she lives.

In most countries anti-D immunoglobulin G (anti-D IgG) is given to rhesus (Rh)-negative women, although evidence is lacking for the need of this intervention after abortion in early pregnancy. This is especially true for medical abortion, which has been used increasingly in recent years. Mifepristone was approved for medical abortion in France in 1988 under the brand name of Mifegyne. The UK and Sweden followed in 1991 and 1992, respectively, and most other European countries in 2000. So far more than one million women have used this method in Europe alone, and the use is still increasing. The need for the application of immunoglobulin in medical abortion has never been evaluated. The necessity seems questionable when the intervention is performed in early pregnancy and in many cases even before a fetal heart rate can be demonstrated by ultrasound. The Swedish Board of Health and Welfare gave a recommendation against the use of anti-D IgG in early spontaneous or medical abortions in 1997. However, there is still no evidence-based analysis for or against prophylaxis. This leads to regional variations in the treatment of early abortion. This paper reviews publications on this subject with the particular aim of providing a background for recommendations or further research initiatives. A review of this kind could not be found in the literature, and has probably not been done recently. This article is based on: a review of the literature in MedLine on the Rh blood group system, fetomaternal hemorrhage (FMH) and Rh (D)-immunization in relation to spontaneous or induced surgical and medical abortion; further articles found as reference in the above-mentioned publications and recommendations from specialists working in the field; recommendations and references from health authorities, abortion providers and manufacturers of Rh immunoglobulins; personal communication with specialists in gynecology and obstetrics, haematology and embryology. The origin of the hematopoietic stem cells (HSCs) that can be found in the hematopoietic organs of the embryo have long been the subject of controversy. The first recognizable blood cells appear within the wall of the yolk sac at about day 17 postconception. The numbers of erythroid burst-forming units (and granulomacrophage progenitors) within the yolk sac decline between the fourth and fifth week after conception, or 6–7 weeks after the last menstrual period (LMP), as they increase reciprocally in the liver. This suggests that HSCs of the yolk sac migrate to the liver, where they establish nests of proliferating cells that may eventually seed other hematopoietic organs of the embryo, including spleen, lymph nodes, thymus and bone marrow. There is a concomitant switching from embryonic to fetal hemoglobin (Hb F) isoforms (1). The role of the yolk sac as the primary source of blood cells is short lived. Its hematopoietic activity decreases rapidly until 10 weeks postconception (12 weeks LMP), when it finally ceases to produce blood cells. At around the fifth week postconception (7 weeks LMP) the hematopoietic activity of the liver quickly becomes the primary source of red blood cells, a position it holds until the 30th week of gestation. The majority of hemoglobin synthesized during the hepatic phase is Hb F. The fetal spleen also commences production of red blood cells at about 10 weeks LMP and continues throughout the second trimester of pregnancy. Bone cavities begin to form red blood cells at about 20 weeks LMP and rapidly become the sole source of hematopoiesis in humans. Additionally, Hb F is gradually replaced after delivery by adult hemoglobin (Hb A), the latter being produced only in the bone marrow. By the end of the first year after birth, Hb A is the only type of hemoglobin that can be found, although some individuals continue to produce a low level of Hb F (1–3). The Rh blood group system consists of a number of inherited antigens. It is the commonest cause of hemolytic disease of the fetus and the newborn. The presence of anti-D antibodies in an Rh (D)-negative woman causes hemolytic disease in an Rh-positive fetus/newborn. The Rh blood group system is also of major importance for hemolytic transfusion reactions. The Fisher–Race nomenclature assumes the presence of three genetic loci for the antigens, each with possible alleles. Today more than 45 antigens in the Rh system are known. The most important are D, c, C, e and E. There are two Rh genes, RhD and RhCE, located on the short arm of chromosome 1. The genes that control their synthesis are not clearly known. There are three codominant alleles; D, d, C, c, E and e. The entire gene complex is inherited as a unit (haplotype). The resulting antigens are named D, C, c, E and e and are inherited in two sets of three; one set from each parent. The most common sets of antigens are Cde (42%), cde (38%) and cDE (14%). Many variations of the D-antigen expression form a heterogeneous group called weak D (previously Du). All weak D forms are considered to be D-positive because of their ability to produce an antibody response. Rh-antigens are proteins (nonsugar containing, like other antigens) that are associated with large membrane complexes on the red blood cell surface. The number of antigenic sites for a specific red cell depends on the genotype (3–5). About 40–50% of all Rh-positive individuals are homozygous for D, having inherited D from both parents. The others (50–60%) are heterozygous for D, having inherited a D-containing set from one parent and a non-D set from the other parent. A child from homozygous Rh-positive parents can only be Rh-positive. A child from a heterozygous Rh-positive couple on the other side can be Rh-positive or Rh-negative. Only an Rh-positive fetus or a blood transfusion of Rh-positive blood is able to cause Rh-immunization in an Rh-negative woman. The antibodies produced by a woman affect only an Rh-positive fetus (3). The presence or absence of the D-antigen denotes an Rh-positive or an Rh-negative individual and for most clinical purposes, people are classified as Rh-positive or Rh-negative by testing their red cells with anti-D antiserum. Because no antiserum specific for d has been found, d in the blood group classification signifies the absence of a discernible allelic product (the d-antigen does not exist) (3,6). On the first antenatal visit, every pregnant woman has her blood group and Rh determined, in case there is no previous record of her blood group. In addition, all Rh-negative women are tested for the presence of anti-D Igs. This is easily done by the indirect (Coombs' test) antiglobulin test for the detection of IgG antibodies. A positive antiglobulin test indicates the presence of antibodies capable of reacting with Rh-positive red cells, and capable of hemolysing them (3). In case of an induced abortion antibodies are not tested. Rh-negativity is a Caucasian trait and its prevalence is around 15%, ranging from 12% in Finns to 35% in Basques. Other populations were probably entirely Rh-positive at one time, but by intermingling genes with Caucasian genes, Rh-negativity appeared. As a result, 8% of American blacks are now Rh-negative, as well as 5% of West Africans and 1% of American Indians. Among Indo-Eurasians 4% are Rh-negative. Less than 1% of indigenous Chinese and Japanese are Rh-negative. Caucasian Rh-negative women have a 60% risk of being pregnant with an Rh-positive fetus. Consequently Rh-incompatibility between an Rh-negative mother and an Rh-positive fetus can be found in 10% of all pregnancies in Europe (5,7,8). The D-antigen is highly immunogenic. The other Rh-antigens are less immunogenic (less risk for sensitization) than D but are of significance. Rh-negative people develop circulating antibodies of anti-D Ig following exposure to Rh-positive red cells (3). Small amounts of Rh-positive blood may be sufficient to produce Rh-immunization. In one study 50% of cases were immunized with 10 mL of Rh-positive blood (3). In other experiments 80% of cases were immunized after one injection of 0.5 mL Rh-positive red cells and 30% were immunized with repeated injections of 0.1 mL of Rh-positive red cells (3). A secondary immune response may occur after exposure to much smaller volumes (0.03 mL) of Rh-positive red cells. About 30% (range 25–50%) of Rh-negative people are never sensitized (nonresponders), even when exposed to large volumes of Rh-positive blood (reviewed in 3). When the fetus is AB0 incompatible to the mother, fetal red cells are less frequently detected in the woman's circulation, and then only in small numbers. Caucasians have a high prevalence of Rh-negativity (15%) and the blood group A (40–50%). It has been estimated that group A incompatibility between mother and infant gives 90% protection against Rh-immunization. Incompatibility of the blood group B gives 55% protection. Consequently AB0 incompatibility confers very significant protection against primary Rh-immune response, but it confers no protection against the secondary immune response (3,7). Studies have also shown that an Rh-positive fetus/infant that initiates an Rh-immunization in the mother is more frequently male than female. The sex ratio of male to female was found to be 1.44–1.74 to 1 (6,7). The primary immune response. The primary immune response develops slowly. In experimental Rh-immunization of male volunteers, the first antibodies develop as early as 4 weeks after injection but it usually takes 8 to 9 weeks before a response appears. The primary response is usually weak and often IgM in nature. IgM does not cross the placenta. IgG appears between 6 weeks to 6 months after antigen exposure. IgG anti-D crosses the placenta and leads to hemolysis of Rh-positive fetal red cells (8). The secondary immune response. Once the primary response has developed, a new exposure to Rh-positive red cells leads to a rapid increase in antibodies, which are mostly IgG in nature. All further exposures thereafter may produce even higher levels of antibodies. If the intervals between antigen exposures are long, both antibody titer and avidity of the antibody for the Rh-antigen will be markedly increased, and the severity of Rh erythroblastosis greater. The antibody titer decreases over time without a new booster. Because of the slow immune response only later pregnancies are at risk for hemolytic disease of the newborn and the fetus (3,8). The transfer of IgG is an active process and takes place only from the mother to the fetus and only via the placenta. IgG is the only immunoglobulin able to cross the placental barrier, via Fc receptors on the plasma membrane of the placenta (7). The heterogeneity of the IgG subclasses produced and the differences in transplacental transfer may explain the differences in the severity of fetal symptoms. The reaction of anti-D antibody with D-antigens leads to the destruction of Rh-positive red cells. This is not a complement-fixing reaction, and most IgG-coated red blood cells are hemolysed extravascularly in the splenic reticuloendothelial system. Antibody-dependent cellular cytotoxicity mechanisms may also contribute (mononuclear phagocytes, lymphoid cells) (6). Immunization to the D-antigen can be prevented by administration of anti-D IgG either before or shortly after exposure to Rh-positive red cells. From an immunological point of view, there are three potential mechanisms of action for the anti-D Ig, antigen blocking, clearance and antigen deviation and central inhibition by generation of antigen-specific suppressor cells near the time of exposure to Rh-positive red cells (6). Rh-immunoglobulin was first released for general use in 1968 and its introduction has very successfully reduced immunization to D-antigen (9,10). Rh-immunoglobulin is very effective if given in adequate amounts at the right time before sensitization has occurred (9). However, it should be noted that anti-D IgG does not protect against development of other antibodies, which may also cause hemolytic disease of the fetus and the newborn. Anti-D IgG is extracted by cold alcohol fractionation from plasma donated by male or female persons with high levels of anti-D IgG antibodies. The donated plasma is pooled and fractionated by commercial manufacturers. Anti-D IgG is prepared in different dosages and is administered as an intramuscular injection (in the deltoid muscle or in the gluteal region). The half-life of this exogenous anti-D IgG is 24 days, but titers decrease over time (11). Studies have shown that the postpartum administration of a single dose of anti-D IgG to Rh-negative women within 72 h of delivery reduces the risk for Rh-immunization by about 85–90%, provided the woman has not already been immunized. The longer the delay between anti-D IgG administration and delivery, the less likely it will be effective (6). The rate of Rh-immunization at 6 months after delivery with subsequent application of anti-D IgG is less than 1% compared to an estimated 16% (range 5–16% in the literature) of Rh-immunization in untreated women after the first Rh-positive and AB0 compatible pregnancy (3,9,10,12). The general recommendation and practice for delivery at term is to administer 250–300 µg anti-D IgG to the mother, provided she is Rh-negative and the fetus is found to be Rh-positive or in case the Rh-status of the fetus is unknown. This routine has been under discussion for many years. An amount of 300 µg of anti-D IgG is considered sufficient to protect against the transfusion of 30 mL fetal blood or 15 mL packed blood cells. However, 99% of women have an FMH of less than 4 mL at delivery (10,13). A potential problem is the development of nonspecific anti-globulin in mothers who receive anti-D IgG. The incidence of this is estimated to be between 5% and 25%. It is unknown if this is of any clinical significance. However, polyclonal IgG will pass from the mother to the fetus (9). There is also increasing concern about the future supplies of anti-D IgG and there is already a shortage in some parts of the world. Subsequently, some physicians in Australia proposed reducing the indications during the first trimester, unless transplacental hemorrhage (TPH) could be documented. The USA might reduce the first-trimester indications and recommend using lower doses of anti-D IgG. In developing countries anti-D IgG is generally not available. However, the number of Rh-negative women is smaller in most parts of the world outside Europe and North America (11), although those few women are at higher risk of beings pregnant with a Rh-positive fetus. The risk of transmission of viral infections [human immunodeficiency virus (HIV), hepatitis B Virus (HBV) and hepatitis C virus (HCV)] via the administration of anti-D IgG is regarded as minimal to absent. No side-effects are known today. Concern about the theoretical risk of contracting Creutzfeldt–Jacob disease from blood products has led to the advice that no plasma products from the UK should be used for the preparation of blood products including anti-D IgG (11). Anti-D IgG has to be stored cold (2–8 °C), which must be considered as a practical problem in some parts of the world. The cost for one dose of anti-D IgG is 560 Skr (61 €). Termination of pregnancy involves trauma to the choriodecidual space, favoring TPH. It has been estimated that more than half of the circulating fetal blood volume is in the placenta. If its selective permeability is lost, this amount of blood might enter the maternal circulation, with the potential risk for sensitization (14). The volume of fetal blood at 8 weeks LMP is estimated to be 0.33 mL. This figure is based on a report that fetal blood represents 30% of placental weight, or approximately 4.2 mL, at 12 weeks. Assuming an exponential growth, the blood volume at 6 weeks would be less than 0.25 mL (15). However, the total blood volume in a fetus younger than 12 weeks has not been verified. No study or information could be found on this subject. It is known that Rh-immunization in an Rh-negative woman is related to previous pregnancies with an Rh-positive baby or transfusions with Rh-positive blood. It has been presumed that early and possibly unrecognized abortion can cause an Rh-immunization, as fetal red blood cells or Rh-antigens from degraded red cells might enter the maternal circulation through defects in the placental barrier during abortion. In this regard it is important to establish the earliest stage of fetal development at which blood group antigens are developed. Bergström et al. found Rh-antigens on the red blood cells of a 10-mm fetus, obtained approximately 38 days after conception or 52 days after LMP (16). The embryo was found in a 47-year-old woman, with systemic lupus erythematosus (SLE), who was undergoing hysterectomy because of a cervical myoma. The embryo had a yolk sac and was obtained within intact membranes. Microscopic examination of the suspension showed almost exclusively nucleated megaloblasts of fetal type. The Rh-antigen was found to be Rh-positive (identified by Löw's method). This is the only report of such an early fetus and the morphology of the blood cells may during the earliest of fetal Rh-antigens in a fetus as as approximately 38 days after conception suggests that early abortion could Rh-immunization in the woman. can be used for fetal in maternal blood. of the most used is the or the This method can one fetal red cell in 20 adult red cells but it has of and is considered as The method considered most is this analysis the maternal blood is first with anti-D and then with cell are found in very small numbers in maternal blood during early and this very method has a risk for the When the method was used for analysis of the have been about as The different used it to the of pregnancy. can occur as early as at 4 weeks following weeks This is the time when fetal and maternal circulation in the placenta has been and when the of the and the action of the fetal heart as low as mL has been detected at this stage of pregnancy the method Hb F cells are found in small numbers in of In about of pregnant women, the level of maternal Hb F the of at about 8 weeks and may (7). This can be considered as a and the of fetal cells by the In one study a majority of pregnant women were found to have an increase in Hb during the first trimester, in the second trimester and at delivery (7). showed that in 80% of pregnancies was very small and that most of the pregnant women were as a of small or TPH. was during a pregnancy. In less than 1% of the cases more than mL and in less than of the cases more than 20 mL of could be In to Hb F was using the method in women in the second and The from 12% at 6 months to at 9 The and amount of Hb F red cells were found to be of and the of the there was a significant increase in Hb F red cells women with Anti-D are by few Rh-negative women during their first pregnancy. The rate for this is The risk of Rh-immunization for an Rh-negative women is considered to be during a pregnancy with an Rh-positive fetus, in case they are AB0 The risk is to be during delivery (3). At delivery after a there is a 99% risk for less than 4 mL and risk for more than 15 mL. It is estimated that µg anti-D IgG would successfully protect against 1 mL of fetal blood cells or approximately mL of fetal blood In spontaneous abortion. that spontaneous abortion in the first trimester can cause primary Rh-immunization could not be found in the There is some evidence that significant only after but does not occur after either or spontaneous et al. were the first to that all women undergoing spontaneous or should receive found Hb F red cells in 35% of women with spontaneous abortion in the first and second trimester weeks LMP) of the women had a for abortion. were higher compared to Hb F in women with a pregnancy of the The of Hb F red cells was found to be of the of the pregnancy in which the abortion In all cases the amount of red cells to a of less than 0.1 mL. It can be that a of less than 0.1 mL will occur during spontaneous abortion or without during the first No immunization was the women undergoing spontaneous abortion. The suggests that there might be no between the amount of and the risk for Rh-immunization after abortion. However, the recommendation for anti-D IgG to all Rh-negative women undergoing abortion is no Hb F is found or et al. women with spontaneous abortion had a incidence of compared to a control group for women with a of 9 weeks less than 20 with abortion as without cervical or of the were and control were were used to the pregnancy and the method was used for fetal red cells. The of the study were not although women with abortion had a higher incidence of In women with a pregnancy had a 4% incidence of during the first and early second control was found to have 4% Hb probably to a of Hb F. if this study not a result, the recommend for all women with abortion. In the Swedish Board of Health and Welfare a recommendation to anti-D IgG to women after early spontaneous or medical abortion The immunization rate in women with early spontaneous abortion was during the following by who could no evidence for an increase in Rh-immunization However, there is a risk that only a few year would not the The recommendation to was later to no general the absence of a in different in In surgical abortion. The of placental and fetal during surgical abortion and probably fetal red blood cells the maternal The under general may the of fetal red blood cells the maternal to anti-D to all Rh-negative women undergoing any kind of abortion often to a study by et al. (15). This is a study to or not in pregnant women undergoing induced abortions less than 8 weeks LMP (15). The of the pregnancies was from LMP and examination were used and were used as a were before and after the to test for fetal cells and were with the cells were found in two women before the abortion and in 12 after the red blood cells could be found in a significant number of women with a pregnancy than 6 weeks No fetal red blood cells could be found in women at less than 6 weeks The that all Rh-negative women at 6 weeks LMP or more should be given anti-D IgG following induced surgical abortion (15). The with this study is the method used to and the of the pregnancy as no was This is a problem found in compared blood before and after surgical of pregnancy (and other abortion medical in the first and second An increase in the number of Hb F cells was found in of the women after the abortion. In 5% the of the was more than 0.1 mL and 1 mL in of the No are given about of pregnancy was et al. the risk of Rh-immunization to be during the first and at but at months and The risk of immunization was to increase with the at abortion. Rh-negative were followed during 9 years. had positive antibody titers in the early phase of their term pregnancy. It was that the after abortion at LMP less than 8 weeks is and all Rh-negative women who have an abortion at months or should receive anti-D IgG and The method for as well as of abortion were not In a frequently et al. Rh-negative women first pregnancy in induced abortion and who were not given anti-D IgG at the time of abortion The was that a secondary immune response never at the of the second pregnancy in In all cases more than 6 months between the abortion and the second pregnancy. The estimated rate of immunization to be about It was also that risk is related to Rh-negative women of the Rh group of the fetus. However, in a in which the rate of Rh-positive is and with it can be that of the of Rh-negative mothers will be Rh-negative because of the of Rh-negative or heterozygous Consequently only 60% of the mothers are at risk of Rh-immunization. on this the risk of immunization in Rh-negative women after abortion amounts not to but to of first pregnancy and of the pregnancy not well in the and the rate of immunization by the end of the first pregnancy was not well known. Because of the smaller blood volume of the fetus during the first trimester it could be that less anti-D IgG should be during this period (in pregnancies 300 µg anti-D IgG is generally considered to protect the women for being et al. Rh-negative pregnant women who for surgical abortion at weeks LMP The women were given doses of anti-D IgG and tested 6 months later for A control group was given 300 µg anti-D IgG. There was no group of untreated of the showed evidence of The was that µg will Rh-immunization in women to 12 weeks of after surgical abortion. The treatment rate was to be about are only in or in most This it to the recommendation of a reduced in early abortion. In medical abortion In and as by and a in could be between surgical and medical abortion and possibly be to of blood at the of fetal blood the maternal circulation, medical abortion and of blood reducing the for fetal cells to enter the maternal circulation performed a small study where they estimated in women before a single dose of of was h before and at the end of the following were compared to a control group with before and after surgical abortion. In the medical abortion group maternal not increase in any of the 20 during the between

BackgroundDuring 2019 NICE and the RCOG introduced UK guidelines normalising the early medical abortion (EMA) protocol for pregnancies prior to 10 weeks gestation. Mifepristone is taken at the abortion clinic,...

Little is known regarding the impact of gestation on pain, bleeding duration, and satisfaction in early medical abortion (termination of pregnancy). This study aimed to determine if pain experience, bleeding duration, and overall satisfaction with medical abortion differed across four ultrasound-defined categories of early pregnancy. This is a secondary analysis of the multicenter VEMA-trial, a randomized clinical trial on the efficacy and safety of very early medical abortion before confirming pregnancy location (the VEMA-trial, EudraCT 2018-003675-35, ClinicalTrials.gov NCT03989869). The present study included participants with normally developing pregnancies and known abortion outcomes, including complete abortion, incomplete abortion, and ongoing pregnancy, that is, pregnancy still progressing after medical abortion. Participants were grouped by ultrasound findings at the time of abortion into pregnancy of unknown location, early, normally sited pregnancy (empty sac), and normally sited pregnancy with visible yolk sac or visible embryo. Pain experience was measured on the 0-10 numeric rating scale (higher values for more pain), duration of bleeding in days, and satisfaction on a 0-6 scale (higher values indicating greater satisfaction). Altogether 1253 participants were included: 18% (224 participants) with pregnancy of unknown location, 38% (476) with early, normally sited pregnancy, 24% (301) with visible yolk sac, and 20% (252) with visible embryo. Pain scores were lowest in the pregnancy of unknown location group (mean 5.2 ± SD 2.3) and highest in the pregnancy with visible embryo group (6.2 ± 2.4). Bleeding duration was shortest for pregnancies of unknown location (4.9 ± 3.2) and longest for those with visible embryo (7.5 ± 5.3). Mean satisfaction was over 5 in all groups, highest in early, normally sited pregnancies (5.7 ± 0.7). In regression analyses, both pain scores and bleeding duration increased with advancing ultrasound findings. The pregnancy of unknown location group reported the least pain (1.02 points lower, 95% Confidence Interval [CI] -1.46 to -0.57) and the shortest bleeding duration (34% shorter, incidence rate ratio 0.66, 95% CI 0.61 to 0.71) compared to pregnancies with visible embryo. More advanced ultrasound findings are associated with higher pain scores and longer bleeding duration in very early medical abortion, whereas satisfaction is high across ultrasound-defined categories.

Early abortion services in the United States: a provider survey

Objective: To explore factors that can influence implementation of a nurse-led model of care for early medication abortion provision in the primary healthcare setting of regional and rural Victoria, Australia. Background: Global research indicates that an increased involvement of primary healthcare nurses in the delivery of early medication abortion provision has the potential to improve abortion access. In Victoria, access in regional and rural areas is restricted despite abortion being legal. A nurse-led early medication abortion provision model is feasible and can potentially improve the current situation. Study design and methods: An online threeround classic Delphi method was used. This paper reports the qualitative findings. Non-probability sampling techniques were used to recruit a panel of professional experts. Data from the three questionnaires were collected and analysed using thematic analysis. Factors influencing model implementation were categorised into the Capability, Opportunity, Motivation-Behaviour framework. Results: A total of 24 medical and other health professionals participated. They identified a range of factors that can hinder model implementation, including a lack of affordable medication abortion education, no remuneration for nurse-led early medication abortion provision, and concerns related to stigma and support. Discussion and conclusion: Understanding and addressing barriers to model implementation may enable the development of primary healthcare nurses’ role in the delivery of early medication abortion provision to improve abortion access. Impact: To improve abortion access in Victoria’s under-served regions, the potential of nurse-led early medication abortion provision was explored. Barriers to model implementation relate to a lack of medication abortion education and funding, professional support and stigma concerns. The study identified a range of support elements that would enable primary healthcare nurses to develop new roles and responsibilities in the delivery of medication abortion services. What is already known about the topic? Evidence indicates that appropriately trained primary healthcare nurses can provide early medication abortion and associated tasks as effectively, safely and satisfactorily as physicians. Nurse-led early medication abortion provision is a worldwide recognised strategy to overcome the shortage of early medication abortion providers and to improve equity in access to abortion services. The legal climate of Victoria allows qualified registered nurses to independently administer physician-prescribed early medication abortion drugs to women. What this paper adds: The Delphi panellists of this study all endorsed nurse-led early medication abortion provision in regional and rural Victoria and beyond. The study provides a range of model implementation barriers, which are categorised into the components of the Capability, Opportunity, and Motivation Model of Behaviour. Those barriers need to be challenged and addressed to improve abortion access in underserved regions.

ObjectivesTo compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to...