International Journal of Epidemiology, 2017, 643–651 doi: 10.1093/ije/dyw270 Advance Access Publication Date: 19 December 2016 Original article Women’s Health Implementing medical abortion with mifepristone and misoprostol in Norway 1998–2013 Mette Løkeland,1,2,3* Tone Bjørge,4,5 Ole-Erik Iversen,1,2 Rupali Akerkar3 and Line Bjørge1,2 1Department of Clinical Medicine, University of Bergen, Bergen, Norway, 2Department of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Norway, 3Department of Health Registries, Norwegian Institute of Public Health, Bergen, Norway, 4Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway and 5Cancer Registry of Norway, Oslo, Norway *Corresponding author. Department of Health Registries, Norwegian Institute of Public Health, Zander Kaaes gt 7, 5015 Bergen, Norway. E-mail: [email protected] Accepted 1 September 2016 Abstract Background: Medical abortion with mifepristone and misoprostol was introduced in Norway in 1998, and since then there has been an almost complete change from pre- dominantly surgical to medical abortions. We aimed to describe the medical abortion im- plementation process, and to compare characteristics of women obtaining medical and surgical abortion. Methods: Information from all departments of obstetrics and gynaecology in Norway on the time of implementation of medical abortion and abortion procedures in use up to 12 weeks of gestation was assessed by surveys in 2008 and 2012. We also analysed data from the National Abortion Registry comprising 223 692 women requesting abortion up to 12 weeks of gestation during 1998–2013. Results: In 2012, all hospitals offered medical abortion, 84.4% offered medical abortion at 9–12 weeks of gestation and 92.1% offered home administration of misoprostol. The use of medical abortion increased from 5.9% of all abortions in 1998 to 82.1% in 2013. Compared with women having a surgical abortion, women obtaining medical abortion had higher odds for undergoing an abortion at 4–6 weeks (adjusted OR 2.33; 95% confi- dence interval 2.28-2.38). Waiting time between registered request for an abortion until termination was reduced from 11.3 days in 1998 to 7.3 days in 2013. Conclusions: Norwegian women have gained access to more treatment modalities and simplified protocols for medical abortion. At the same time they obtained abortions at an earlier gestational age and the waiting time has been reduced. Key words: Medical abortion, mifepristone, misoprostol, Norway, registry VC The Author 2016. Published by Oxford University Press on behalf of the International Epidemiological Association 643 This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by- nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work properly cited. For commercial re-use, please contact [email protected] 644 International Journal of Epidemiology, 2017, Vol. 46, No. 2 Key messages • There has been an almost complete change in abortion treatment in Norway from predominantly surgical abortion in 1998 to medical abortion in 2013. • Norwegian hospitals follow national and international guidelines. • After the introduction of medical abortion, women access abortion at an earlier gestational age and waiting time from the request of an abortion to termination has been reduced. Introduction fewer human and economic resources and can be more cost- Termination of pregnancy is one of the most common proced- effective than surgical abortion, especially if the number of 12,13 ures in reproductive health. At the same time it is one of the visits for treatment and follow-up are reduced. Medical more controversial and politically contentious procedures in abortion was included in the Norwegian national guidelines medicine.1 The abortion rate in the world is declining, but for abortion treatment up to 9 weeks of gestation in 2004. the proportion of unsafe abortions is increasing.2 In Norway The recommended treatment protocol was 200–600 mg the abortion rate has been relatively stable, ranging from mifepristone, admission to hospital and administration of 14 12.5–14.5 per 1000 women aged 15–49 between 1995 and 800 mg misoprostol after 42–48 h. In 2009, the guidelines 2013 (14).3 Misoprostol used for clandestine abortions is were altered to recommend self-administration of misopros- associated with lower risk of maternal mortality and morbid- tol vaginally at home and to extend the gestational limit of 15 ity than unsafe surgical abortions, but there is a lack of know- medical abortion from 9 to 12 weeks of gestation. ledge about the correct use for pregnancy termination.2 Some critics have feared that increased access to med- 4 Increased knowledge and the combined use of mifepristone ical abortion would increase the number of abortions. and misoprostol could help reduce maternal deaths, particu- From the introduction of medical abortion with mife- larly in areas with limited numbers of health professionals and pristone and misoprostol in Norway, there has been an al- low access to health services in both legal and illegal settings. most complete change in abortion procedures from close Norway began offering medical abortion with mifepris- to 100% surgical abortions in 1997 to 82.1% of all abor- 3 tone and misoprostol in 1998. Due to a dispute in tions being performed medically in 2013. Approximately Parliament over a planned clinical trial of mifepristone in 95% of all abortions are performed within 12 weeks of 3 1989 (Figure 1), the pharmaceutical company producing gestation. There is some knowledge on why some women mifepristone withdrew their application to register mifepris- prefer medical abortion whereas others opt for surgical 16 tone in Norway.4 In 1998, mifepristone was introduced in abortion, but little is known about possible differences in Norway as a drug with exemption from registration. characteristics between these two populations in Norway. 5 This study describes the implementation process of med- Mifepristone was registered for use in Norway in 2001. ical abortion in Norway over the first 15 years after the intro- Norway has a public health system and every department of duction in 1998 (Figure 1) and the current abortion practice obstetrics and gynaecology in the country is obliged to per- at Norwegian hospitals based on a facility survey sent to all form abortions completely free of charge. Only physicians hospitals providing abortion services at the two time points, are entitled to perform abortions, but delegation to other 6 2008 and 2012. Data from the Abortion Registry are used to health professionals under supervision is not prohibited. describe the proportion of abortions that were undertaken Doctors always undertake surgical abortions, whereas med- medically or surgically from 1998 to 2013 and to compare ical abortions very often are allocated to nurses. No abor- the characteristics of women who chose medical versus surgi- tions are performed outside the public health system. Since the registration of mifepristone in France in 1988, cal abortions. We also evaluated if the almost complete medical abortion with mifepristone and misoprostol has change in abortion practices influenced the waiting time from been available, is thoroughly documented for use up to 9 request for an abortion until termination. weeks of gestation and was in 2016 approved for use up to 7,8 70 days by the US Food and Drug Administration. Over Methods the past 25 years, the treatment procedures have been modi- fied and introduced for use in both late first trimester and Study design and material second trimester abortions, and it has become available in a First, this is a review of the practice and implementation of growing number of countries.9–11 Medical abortion requires medical abortion in Norway through a survey sent to all International Journal of Epidemiology, 2017, Vol. 46, No. 2 645 hospitals offering termination of pregnancy at two time points, in 2008 and 2012. Second, it is a study of 223 692 women in the Abortion Registry who requested abortion and terminated a pregnancy up to 12 weeks of gestation in the years 1998 to 2013. Hospital surveys In 2008, a questionnaire was elaborated by the research group and sent by mail to all 40 departments of obstet- rics and gynaecology performing abortions in Norway [helseadresser.no] with the purpose of mapping the preva- lence and distribution of medical abortion and treatment protocols. The survey was repeated in 2012 after a rapid increase in medical abortion was reported by the Abortion Registry.3 Due to merging of closely located clinics, the number of hospitals was reduced to 38. Information about the existing treatment portfolio was obtained through the questions: do you offer medical abortion up to 9 weeks of gestation, medical abortion with home administration of misoprostol, and medical abortion between 9 to 12 weeks of gestation; and in which years were the different treatment options introduced. In addition, dosages of mife- pristone (200 mg, 400 mg, or 600 mg), route of adminis- tration of misoprostol (oral or vaginal), and follow-up regimen used ([serum-human chorionic gonadotropin (s-hCG); urine-hCG; ultrasound/clinical or no control] were requested. Abortion Registry The Abortion Registry was established in 1979 and is a population-based,