Acceptability of home use of mifepristone for medical abortion

doi:10.1016/j.contraception.2012.10.021

Contraception

Volume 88, Issue 1, July 2013, Pages 122-127

https://doi.org/10.1016/j.contraception.2012.10.021 Get rights and content

Abstract

Background

Most medical abortion protocols require women to take mifepristone in the doctor's office. We assessed the acceptability of home use of mifepristone among women and their providers.

Study Design

In this multicenter trial, eligible women requesting termination of early pregnancy (n= 301) chose whether to take mifepristone in the office or at home. Data on safety, efficacy, acceptability and disability were collected.

Results

One hundred thirty-nine women (46%) chose to take mifepristone at home, and 162 (54%) chose office administration. Ninety-five percent of home users said that they would take the mifepristone in the same place in the future. Home users were not more likely to call the doctor's office or make an unplanned visit, and providers would recommend home use again for 95% of patients who chose home use.

Conclusions

Home administration of mifepristone was safe and acceptable to women and providers in our study. Women should be offered this choice to allow more flexibility, comfort and privacy in their abortion experiences.

Introduction

Due to the politicized nature of abortion in the United States, mifepristone is distributed and dispensed in a highly unusual manner. Mifepristone is supplied only to physicians who sign an agreement with the distributor and is not available in pharmacies. In addition, mifepristone is generally administered under the direct observation of a physician or nurse. These conditions are specified in the manufacturer's label approved by the Food and Drug Administration [1]; however, there is a long history of off-label use in the US for other aspects of mifepristone provision where supportive data exist. Despite the fact that mifepristone has few to no side effects for most women, no data have been gathered on mifepristone use outside the constraints of office provision in the US. A descriptive study of women overseas who acquired both mifepristone and misoprostol from the Women on the Web website and self-administered the tablets reported a success rate similar to rates reported for other outpatient settings (93%) [2].

Women considering medical abortion may assume incorrectly that the abortion will occur on the day of their appointment and accordingly plan their visit around the demands of childcare, work and school. However, the most severe bleeding and cramping usually occur 1 to 3 days after the appointment, after the woman takes the misoprostol. Therefore, requiring women to take mifepristone in the doctor's office can interfere with patients' ability to plan how the abortion will fit into their lives because it forces them to initiate the bleeding process at a time when it may be costly or inconvenient. Appointments are often not available at the most convenient times for patients. By contrast, if a woman were sent home with both medications, she could plan to experience bleeding over the weekend or at another time that is suitable for her so that she can avoid schedule disruption or loss of income. Offering women the option to take mifepristone at home may also enhance patient choice for those women who come to the doctor's office intending to have a medical abortion but ultimately choose to have a surgical abortion because of scheduling issues. Lastly, home use of mifepristone has the potential to increase patient satisfaction for those women who wish to start the medical abortion process in the privacy of their homes, with their partners or families.

Many studies of medical abortion have sought to increase acceptability by giving women greater flexibility and autonomy [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21]. Similarly, the objective of this study was to assess the acceptability of home use of mifepristone for termination of pregnancy among women who choose it and their providers. We also aimed to compare the experiences of women using mifepristone at home to those of women taking mifepristone in the doctor's office and to estimate the proportion of women who might be interested in this new option.

Section snippets

Methods

Women presenting for termination of pregnancies up to 63 days of gestation were recruited for this prospective, nonrandomized multicenter trial. The study was conducted from May 2009 through November 2010 at four urban, demographically diverse clinical sites in New York City, Philadelphia and Atlanta. Ethical approval for the study was obtained from the Allendale Institutional Review Board, as well as the institutional review boards of the Montefiore Medical Center, the Institute for Family

Results

Between May 2009 and November 2010, the study sites enrolled 301 women, 139 (46.2%) who chose home use of mifepristone and 162 (53.8%) who chose office use. The proportion of women who chose home use ranged from 41%–54% among the four study sites. Thirteen women (9.4%) in the home-use group and 25 women (15.4%) in the office-use group were lost to follow up (p=.11). Outcome data were available for a total of 260 participants, and success rates did not differ between groups (96.7% for home users

Discussion

Our study shows that women are able to administer mifepristone safely and properly outside of the doctor's office and that administration under direct medical supervision is unnecessary. There were no differences in rates of efficacy or complications between participants who took the mifepristone at home or in the office. All women who opted for home use of mifepristone took it within 63 days' LMP, which is the current evidence-based gestational age limit for use, and all study participants

Acknowledgments

We thank Kathryn Conkling for data management and Molly Gaebe, Carrie Miller, Gloria Nesmith and Finn Schubert for study coordination.

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Cited by (41)

Client satisfaction and experience of telemedicine and home use of mifepristone and misoprostol for abortion up to 10 weeks’ gestation at British Pregnancy Advisory Service: A cross-sectional evaluation
2021, Contraception
Evaluate satisfaction and experience with telemedicine consultation and home use of mifepristone and misoprostol for abortion to 10 weeks’ gestation.
Cross-sectional evaluation of British Pregnancy Advisory Service (BPAS) clients who used mifepristone and misoprostol at home from 11 May to 10 July 2020. We sent a text message with a link to a web-survey 2 to 3 weeks postabortion. Questions assessed satisfaction and experiences with a service model including telephone consultation and provision of medicines by mail or collection from the clinic. We used bivariate and multivariate regression to explore associations between client characteristics and outcomes. Our primary outcomes were overall satisfaction (5-point Likert scale) and reported contact with a health care provider.
A total of 1,333 clients participated. Respondents described home use of medications as “straightforward” (75.8%) and most were “very satisfied” (78.3%) or “satisfied” (18.6%) overall. Being “very satisfied” was associated with parity (aOR 1.53, 95% CI 1.09−2.14) and pain control satisfaction (aOR 2.22, 95% CI 1.44−3.44). Health care provider contact was reported by 14.7%; mainly to BPAS’ telephone aftercare service (76.8%). Dissatisfaction with pain control (aOR 3.62, 95% CI 1.79−7.29) and waiting >1 week to use mifepristone (aOR3.71, 95% CI 1.48−9.28) were associated with health care provider contact. If needed in the future, most would prefer consultation by phone (74.3%) and home use of mifepristone and misoprostol (77.8%).
Satisfaction with telemedicine and home use of mifepristone and misoprostol is high. Most clients do not need health care provider support when administering medicines at home or post abortion.
Expanding access to medication abortion through pharmacy dispensing of mifepristone: Primary care perspectives from Illinois
2021, Contraception
Medication abortion is safe and effective, yet access is limited by a strict Risk Evaluation and Mitigation Strategy (REMS) that prohibits pharmacy dispensing of mifepristone. Given the ability of primary care providers (PCPs) to expand medication abortion access, we assessed PCP perspectives on how lifting the mifepristone REMS would affect the provision of medication abortion in primary care.
We conducted a qualitative study of PCPs and administrators in Illinois with experience or interest in providing medication abortion care at their practice. The final sample (N=19) consisted of seven family medicine physicians, three nurse practitioners, four certified nurse midwives, and five administrators. We queried participants on how removing the REMS to allow pharmacy dispensing of mifepristone would affect their ability to provide medication abortion. We conducted interviews via telephone and used ATLAS.ti to manage our transcripts; we analyzed these data for major themes regarding pharmacy dispensing.
Primary care providers expressed support for pharmacy dispensing due to its ability to help normalize medication abortion, reduce implementation barriers in primary care, and expand abortion access. Further challenges to address if the REMS restrictions are lifted include federal funding restrictions on abortion, concerns about unsupervised mifepristone use, and pharmacy cooperation.
Removing the mifepristone REMS to allow pharmacy dispensing could help normalize medication abortion care, facilitate provision in primary care, and address disparities in abortion access.
Our findings illuminate novel benefits of removing the mifepristone REMS and highlight methods to promote successful implementation of pharmacy dispensing. Combined with prior literature, these results support prompt reevaluation and removal of the REMS to align medication abortion care with evidence-based practices.
A Retrospective Cost-Effectiveness Analysis of Mifepristone–Misoprostol Medical Abortions in the First Year at the Regina General Hospital
2021, Journal of Obstetrics and Gynaecology Canada
Citation Excerpt :
Mife/miso is safe, effective, and generally considered acceptable by patients and providers.3,5–12 It is 95% to 98% effective up to 49 days after last menstrual period and 87% to 98% effective up to 63 days,3,6,8–11 and there is emerging evidence of safety and efficacy up to 77 days.3,12–15 The first Canadian retrospective case series of mife/miso implementation found 96.7% effectiveness at a GA of up to 63 days.16
In July 2017, mifepristone–misoprostol (mife/miso) became available for medical abortion at the Regina General Hospital's Women's Health Centre (RGH WHC). We investigated whether the proportion of abortions performed medically changed as a result of the introduction of mife/miso, whether using mife/miso instead of the surgical alternative would result in cost savings to the health care system, and whether abortion type differed between patients residing in and outside of Regina.
We conducted a retrospective chart review of all 306 medical abortions from the RGH WHC between July 1, 2017 and June 30, 2018. We obtained medical and surgical abortion information from that year and the preceding one from an administrative database. Statistical methods were used to calculate the costs of mife/miso, methotrexate-misoprostol (MTX/miso) and surgical abortion, as well as cost-effectiveness ratios.
The proportion of medical abortions increased from 15.4% in 2016/2017 to 28.7% in 2017/2018 (χ²₁ = 54.629; P < 0.001). Calculated costs for mife/miso, with and without complications were CAD $1173.70 and CAD $1708.90, respectively, versus CAD $871.10 and CAD $1204.10, respectively, for MTX/miso, and CAD $1445.95 and CAD $2261.95, respectively, for hospital-based vacuum aspiration. At a willingness-to-pay threshold of CAD $318 (the cost of mife/miso), statistical modelling showed a 61.3% chance that mife/miso was more cost-effective than surgical abortion and a 90.8% chance that it was more cost-effective than MTX/miso. Patients from Regina were significantly more likely (χ² ₁ = 29.406; P < 0.001) to receive a medical abortion (34.9% of abortions) than those living outside of Regina (19.6% of abortions).
The proportion of abortions completed medically increased significantly over the period studied. Patients from Regina were more likely to receive medical abortion during both time periods. Mife/miso had a >50% probability of cost-effectiveness over both surgical and MTX/miso options.
En juillet 2017, la combinaison mifépristone-misoprostol a été rendue disponible aux fins d'avortement médicamenteux au centre de santé des femmes du Regina General Hospital. Nous avons tenté de déterminer si l'arrivée de la mifépristone-misoprostol avait eu une incidence sur la proportion d'avortements médicamenteux, si le recours à la mifépristone-misoprostol plutôt qu’à l'avortement chirurgical allait engendrer des économies pour le système de santé, et si le type d'avortement pratiqué différait entre les patientes qui habitent à Regina et à l'extérieur.
Nous avons mené un examen rétrospectif des dossiers médicaux pour tous les avortements médicamenteux réalisés au centre de santé des femmes du Regina General Hospital entre le 1^er juillet 2017 et le 30 juin 2018. Nous avons obtenu les renseignements relatifs aux avortements médicamenteux et chirurgicaux réalisés pendant cette année et la précédente à partir d'une base de données administrative. Nous avons utilisé des méthodes statistiques pour calculer les coûts de la mifépristone-misoprostol, du méthotrexate-misoprostol et des avortements chirurgicaux, ainsi que les rapports coûts-efficacité.
La proportion d'avortements médicamenteux a augmenté, passant de 15,4 % en 2016-2017 à 28,7 % en 2017-2018 (χ²₁ = 54,629; P < 0,001). Les coûts calculés de la mifépristone-misprostol, avec et sans complication, étaient de 1173,70 $ CA et 1708,90 $ CA, respectivement, par rapport à 871,10 $ CA et 1204,10 $ CA, respectivement, pour le méthotrexate-misoprostol, et à 1445,95 $ CA et 2261,95 $ CA, respectivement, pour l'avortement par aspiration à l'hôpital. D'après un seuil de disposition à payer de 318 $ CA (le coût de la mifépristone-misprostol), le modèle statistique a révélé que la mifépristone-misprostol avait 61,3 % des chances d’être plus économique que l'avortement chirurgical et 90,8 % des chances d’être plus économique que le méthotrexate-misoprostol. Les patientes de Regina étaient significativement plus susceptibles (χ² ₁= 29,406; P < 0,001) de subir un avortement médicamenteux (34,9 % des avortements) que les patientes vivant à l'extérieur de Regina (19,6 % des avortements).
La proportion d'avortements médicamenteux a augmenté de manière significative au cours de la période à l’étude. Les patientes de Regina étaient plus susceptibles de subir un avortement médicamenteux au cours des deux périodes. La mifépristone-misoprostol présentait une probabilité de > 50 % de rapport coût-efficacité favorable par rapport à l'avortement chirurgical et l'avortement médicamenteux par méthotrextae-misoprostol.
Women's voices and medical abortions: A review of the literature
2020, European Journal of Obstetrics and Gynecology and Reproductive Biology
Globally, a growing proportion of induced abortions are medical abortions. The procedure has been hailed as a revolutionary technology, which, according to experts, has the potential to transform women’s experiences of abortion and the way abortion services are accessed. Noticeably absent in the discourse, however, are women’s voices. More specifically, there is a lack of understanding about what shapes women’s preferences for medical abortion and the challenges they experience in accessing the drugs for the procedure. We conducted a systematic review of the literature to draw attention to these important issues which exist, but are often embedded within research highlighting other dominating aspects of medical abortions. A comprehensive search of four databases - supplemented by searching reference sections of selected articles, tracking their citations, and hand searching special editions on medical abortion - was conducted. A total of 45 peer-reviewed studies met our inclusion criteria. The studies were assessed for quality and analyzed using a critical interpretive synthesis approach. The findings revealed significant variations in women’s preferences for surgical versus medical abortions. Country-specific abortion laws, implementing protocols, side-effects, rates of failures, and the need to verify the abortion shaped women’s preference for abortion methods. Overall, women who preferred medical abortions did so because they perceived it as a ‘natural’ and safe procedure that can be self-conducted at home, thereby reducing their dependency on the health system. However, women face significant barriers to medical abortion care. These include legal requirements around type of provider, site of service, need for follow-up, providers’ limited knowledge of the procedure, and preferences for surgical abortions. Borderless internet-based services have enabled some women to circumvent these barriers. Our review suggests that medical abortions are used by women either in countries where the health system is fully supportive or where the health system is completely disengaged, usually due to restricted abortion laws. In those countries where abortions are legal but often difficult to access due to health system barriers, women tend to prefer surgical abortions.
“We've got rights and yet we don't have access”: Exploring patient experiences accessing medication abortion in Australia
2020, Contraception
Across Australia, multiple strategies have emerged to decentralize abortion care and increase access to mifepristone, including incorporating medication abortion into primary care and offering the mifepristone and misoprostol regimen via telemedicine. We aimed to explore the experiences of patients accessing medication abortion care across these different health service delivery formats and different geographic areas.
We conducted in-depth interviews with 22 people from across Australia who had used mifepristone for abortion. We audio-recorded and transcribed all interviews and managed our data with ATLAS.ti. We used deductive and inductive techniques to analyze these data for content and themes.
Although participants were generally satisfied with the abortion care they received, many described medication abortion care in Australia as inaccessible and confusing to find. Our participants incurred variable and often significant financial costs when obtaining their abortion and many reported that their interactions with general practitioners when trying to locate an abortion provider were uninformative and stigmatizing. Participants were enthusiastic about obtaining medication abortion through a variety of service delivery modalities, including telemedicine, and believed these strategies could increase equitable and affordable access.
Barriers to finding and accessing abortion care persist across Australia. Efforts to challenge the over-regulation of mifepristone, increase the affordability of medication abortion, and enhance training opportunities to educate a variety of clinicians about medication abortion and support provision from a range of providers appear warranted.
The continued over regulation of mifepristone creates barriers for incorporating medication abortion into primary care settings and has significant implications for patient access and abortion stigma. Regulatory reform and provider education and training have the potential to improve abortion patients’ experiences with medication abortion.
Acceptability and feasibility of outpatient medical abortion with mifepristone and misoprostol up to 70 days gestation in Singapore
2018, European Journal of Obstetrics and Gynecology and Reproductive Biology
The aim of the study was to examine the acceptability and feasibility of using a combined regimen of 200 mg mifepristone and 800 μg buccal misoprostol in an outpatient abortion service in Singapore, where mifepristone is not currently registered.
The pilot prospective study enrolled 130 women who sought termination of pregnancies up to 70 days gestation at two public hospitals in Singapore. Women received 200 mg mifepristone to take at the clinic or at home, followed 24 h later by 800 μg buccal misoprostol administered at home. A follow-up visit was scheduled seven to ten days after mifepristone to confirm the outcome of the abortion. The primary outcome was rate of successful abortion and secondary outcomes were women’s preference for location of mifepristone administration and satisfaction with the method.
The large majority of women (96.8%) had successful abortions without recourse to surgical intervention. Most women (88.2%) chose to take mifepristone at the clinic. Most women reported the side effects as acceptable (68.3%) or neutral (26.0%). Almost all women (94.4%) were very satisfied or satisfied with the method.
Outpatient medical abortion with mifepristone and misoprostol up to 70 days gestation is acceptable and feasible and has the potential to expand available options in Singapore.

View all citing articles on Scopus

^☆: Funds to carry out this study were provided by an anonymous donor without financial interests in the outcome of this study.

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Original research articleAcceptability of home use of mifepristone for medical abortion☆

Abstract

Background

Study Design

Results

Conclusions

Introduction

Section snippets

Methods

Results

Discussion

Acknowledgments

Eur J Obstet Gynecol Reprod Biol

Wom Health Iss

Contraception

Contraception

Contraception

Int J Gynaecol Obstet

Contraception

Int J Gynaecol Obstet

Contraception

Contraception

Int J Obstet Gynecol

Original research article
Acceptability of home use of mifepristone for medical abortion☆