Patients’ satisfaction with first trimester
mifepristone - misoprostol medical abortion services
A literature review
Mihaela Zoe Poenariu, MD
Department of Research and Training
East European Institute of Reproductive Health
See also presentation
OBJECTIVES: To summarize the conclusions drawn and recommendations made by previous research with regard to medical abortion acceptability.
DATA SOURCES: search on the Internet in databases from the Ovid system (CDSR, ACP Journal Club, DARE, CCTR, CINAHL, HealthSTAR, Pre-MEDLINE, MEDLINE, Embase Psychiatry, Socio-File) Popline and journal collections hosted by HealthWire, PubMed and Scielo. Full text articles were selected and abstracts of relevant articles helped retrieving them from the printed editions of the journals.
METHODS OF STUDY SELECTION: Only studies describing in detail mifepristone-misoprostol acceptability were selected in the primary search. Safety and efficacy studies on the regimen containing little data on acceptability were excluded from the analysis, but were retained for the discussion section to prove the general acceptability trend on the topic and the need for additional adequate research, especially qualitative. Studies reporting on the use of mifepristone or misoprostol for second trimester abortion or for other indications were excluded. Studies with small sample sizes were also excluded. Only comparative studies (mifepristone-misoprostol regimen versus vacuum aspiration) were selected for the analysis. Five studies (4 cohort studies and a review) matched the research question and were included in the analysis.
RESULTS: Medical and surgical abortion acceptability was high in all studies. Patients (either surgical or medical) who have options to choose between a range of methods have generally a higher satisfaction with the abortion experience. Also, they are more likely to choose the same method in the future and to recommend it to a friend. Women chose medical or surgical abortion for variety of reasons, but subjects in both samples were interested in method safety, efficacy, pain avoidance, and convenience. Method failure was a major reason for dissatisfaction.
CONCLUSIONS: Both medical and surgical abortion was acceptable to women, especially to those who have exercised a choice of method. Safety, efficacy and pain control were major concerns influencing choice and the acceptability of the abortion experience in both surgical and medical samples. Method drawbacks (i.e. pain, bleeding, duration until expulsion) did not have major impact on acceptability. For many women, induced abortion (medical or surgical) is a stressful event and proper information prior to the procedure can help shape the expectations and overcome the experience.
KEYWORDS: acceptability, satisfaction, perspectives, mifepristone, misoprostol, drug-induced abortion
1.1. Abortion: definitions, prevalence
The term “abortion” refers to the termination of pregnancy for whatever cause before the fetus is capable of extrauterine life. “Induced abortion” refers to the termination of pregnancy through a deliberate intervention intended to end the pregnancy (1). The term “medical abortion” commonly refers to early pregnancy termination (usually before 9 weeks’ gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. Medical abortion is typically considered a failure when a surgical evacuation is performed to complete the abortion for any reason, including incomplete abortion, continuing (viable) pregnancy, hemorrhage, or patient request (2) .In contrast, surgical abortion is considered a failure only if a continuing pregnancy occurs; if a repeat aspiration is required for an incomplete abortion or hematometra, it is considered a complication, not a method failure (3).
The magnitude of unwanted pregnancies ending in induced (surgical) abortion rises to 36 to 53 million each year (4) Women who have unwanted pregnancies should have ready access to reliable information and compassionate counseling and in circumstances in which abortion is not against the law, such abortion should be safe (5). Estimates suggest that more than half of these abortions are performed under unsafe conditions and result in more than 70,000 deaths per year, almost all in developing countries. In some developing countries the complications of unsafe abortion, including incomplete abortion, sepsis, hemorrhage, and intra-abdominal injury, cause the majority of maternal deaths, and in a few countries they are the leading cause of death for women of reproductive age (6). Bearing in mind the severe medical, social, and economic consequences of unsafe (surgical) abortion in developing countries, there is a great need to develop safe, effective, and acceptable methods of medical abortion. Such methods may be particularly important in resource-poor conditions where inadequate surgical services for abortion may entail a very high risk of infection and reproductive tract injury (7).
1.2. Medical abortifacients: drugs, regimens
Historically, although the idea of using medications to induce late menses or cause abortion dates back centuries, medical proven regimens have been developed only during the last 50 years Various abortifacients have been developed and tested in clinical trials over the years: natural prostaglandins (PG E2, PG F2a.) prostaglandin analogues (gemeprost, sulprostone, misoprostol), antiprogesteronic agents (mifepristone) and cytotoxic drugs (methotrexate) (6, 8). Natural prostaglandins (administered intravaginally or transcervically) and injectable sulprostone although very effective in inducing abortion caused high rates of gastrointestinal side effects (6). PG E1 prostaglandin analogues currently used for medical abortion are gemeprost (available in vaginal suppositories of 1 mg) and misoprostol (available in tablets containing 0.2 mg). In contrast to gemeprost, misoprostol is stable at room temperature, is on the market in a large number of countries and is also considerably cheaper than gemeprost. Although it is meant for oral use, vaginal administration of the tablets is often used and found more effective in stimulating uterine contractility. The interval from start of treatment to a noticeable effect is significantly shorter following oral administration but more importantly the duration of stimulation is significantly longer following vaginal administration. Adding water to the tablets prior to the treatment increases the overall success rate in misoprostol administered alone, reaching a clinically acceptable efficacy for pregnancies less than 7 weeks (9). Methotrexate acts predominantly on the trophoblast and its abortifacient effect may take some days or weeks to occur (8).
Since it was observed that prostaglandin analogues increase the efficacy of mifepristone as an abortifacient, combined regimen of mifepristone (600 mcg orally) and prostaglandins, particularly oral misoprostol (400 mcg orally), (“the French regimen”) have been developed over the last decade and proved safe and efficient, with complete abortion rates over 90%, especially for pregnancies less than 49 days (10, 11, 12, 13). Administering misoprostol via vaginal route (800 mcg) further increased regiment efficacy and resulted in less gastrointestinal disturbances usually related to the prostaglandin component of the regimen (14, 15). Several randomized double-blind studies have demonstrated that the dose of mifepristone can be lowered to 200 mg, one-third of the original dose, without compromising efficacy (13, 16, 17, 18, 19). Vaginal misoprostol administration allowed for misoprostol doses to be reduced and given at different time (1, 2 or 3 days) after mifepristone intake, without compromising efficacy (20, 21 22). Other routes (i.e. sublingual) and take-home protocols for misoprostol administration are currently explored. Regimens with methotrexate (50 mg/m2 intramuscularly) and misoprostol have proven efficient (23) in the same range as mifepristone and misoprostol but they take longer to expel the pregnancy tissue (24).
To become widely used, a new method of abortion must be acceptable to its potential consumers and providers. Rather than being strictly an inherent quality of a method, acceptability is the result of an interaction among the values a person holds, the individual's perceptions of the attributes of particular products, and the service delivery system the consumer encounters. If a method's perceived attributes correspond to a consumer's values, that individual may consider the method desirable, preferable or acceptable. Anything affecting values or perceptions can therefore affect acceptability. Characteristics that may influence both values and perceptions include ethnicity, nationality, culture, class, education, personality and experience. Perceptions are also influenced by the inherent qualities of an item and the available alternatives (25). Previous research on abortion has identified some attributes that are important to acceptability. These attributes include efficacy, safety, freedom from side effects and pain, ease or convenience, gentleness and noninvasiveness, privacy, autonomy and affordability (26).
The acceptability literature is difficult to summarize, partly because medical abortion regimens have evolved rapidly over the last decade. These regimens may use antiprogestins or prostaglandin analogues, or some combination of the two. Mifepristone is an oral medication, but the prostaglandins may be administered orally, vaginally or intramuscularly. Reported side effects of the procedure have ranged from minimal to extremely serious. Service delivery has been no more uniform: Some women have been treated as inpatients, others as outpatients, and still others have taken the drugs at home. These differences may greatly affect the perception and acceptability of a method's characteristics. The characteristics of the surgical abortion techniques to which women may compare medical regimens also vary. For example, vacuum aspiration can be provided as an inpatient or outpatient procedure and can be carried out under general or local anesthesia. Individuals in comparative studies are thus assessing various medical abortion regimens against an alternative that varies from study to study.
Despite the variety of regimens and protocols, clinical research has shown that regardless of the drugs or procedures used, some characteristics appear to be intrinsic features of current methods of medical abortion. When compared to surgical abortion, medical abortion offers slightly lower efficacy, takes longer from initiation to completion, leaves the patient more conscious of bleeding and of expulsion of the products of conception, and hinders the provision of other procedures for fertility regulation (e.g., IUD insertion or sterilization). Patients who object strongly to one or more of these characteristics may reject medical methods. For these women, improvements in acceptability can come only with further advances in technology. Several other differences from surgical abortion that might at first appear intrinsic to medical methods actually depend on service delivery choices. These features include additional medical visits, pain (functions of the type of anesthesia used in surgery and the dose and type of prostaglandin used for medical abortion) and absence of the requirement for admission to the hospital, still a part of the surgical protocol in some cases. Cost cannot be evaluated because experimental techniques are often provided without charge. In most countries where the medical regimen is now offered, its price is sheltered from market forces so that the cost to patients is the same as surgical abortion (25).
2. Rationale and objectives
Many studies using mifepristone-misoprostol abortion are focused on method safety, and/or efficacy. Most of these studies are randomized controlled studies, some of which have a minor, if any, component on client or provider acceptability – using a quantitative research approach.
Medical abortion, using a qualitative approach, is less studied in depth.
Randomized controlled studies exploring the medical abortion safety, efficacy and the acceptability issue recommended that in depth acceptability studies should be carried out.
I have undertaken this endeavor to systematically search the literature available on mifepristone-misoprostol patient acceptability studies with the aim to provide a body of evidence and a comparison basis for the data collected at the East European Institute of Reproductive Health on this topic from 145 medical abortion clients and 178 surgical clients undergoing voluntary first trimester pregnancy termination at the abortion facility of the Targu - Mures University Teaching Hospital.
- To explore the extent to which medical abortion acceptability has been addressed by previous studies
- To assess the balance between quantitative and qualitative research studies addressing medical abortion acceptability
- To display the body of evidence that previous research has provided on medical abortion acceptability to clients
- To summarize the conclusions drawn and recommendations made by previous research with regard to medical abortion acceptability
- To provide a comparison basis for the qualitative research on acceptability among surgical and medical abortion clients and providers carried out by the East European Institute of Reproductive Health
3.1. Search strategy
I have performed a search on the Internet in several large databases, such as those provided by the Ovid system (including CDSR, ACP Journal Club, DARE, CCTR, CINAHL, HealthSTAR, Pre-MEDLINE, MEDLINE, Embase Psychiatry, Socio-File), Popline. Also, I searched the relevant journal collections hosted by HealthWire, PubMed and Scielo. Full text articles were downloaded in PDF or HTML format from the Internet or extracted from printed editions of journals available at the WHO library and the Geneva Medical University library.
The keywords were: acceptability, satisfaction, perspectives, mifepristone, misoprostol, drug-induced abortion. The main problem encountered was the fact that medical abortion is not a MeSH term, and therefore I had to perform a secondary search using MeSH terms closed to medical abortion listed in the system (drug induced abortion, induced abortion, abortifacients); The limited length of search expression for some databases, i.e. “first trimester” could not be included as a keyword in the search expression and some articles regarding the use of misoprostol during the second trimester had to be excluded from the search results list.
3.2. Selection criteria
- Experience of medical / surgical abortion respectively
- First trimester pregnancy
- Technical procedures
- For medical abortion: a combination of mifepristone + misoprostol (various dosages and routes)
- For surgical abortion: electric vacuum aspiration or sharp curettage
- Full text articles
- Language: no limitation
- Opinion polls (collected either in focus group discussions or in interviews) expressing women’s/providers’ views about medical abortion with no prior experience of medical abortion
- Gestational age over 9 weeks
- Findings from centers participating in multicenter research studies already reported by the multicenter report
Studies providing comparisons between the mifepristone and misoprostol method and other medical regimens (including methotrexate and other prostaglandin analogues than misoprostol) were also retained from the list to be used in the discussions section of this paper. Also, studies reflecting the dynamics of medical abortion acceptability triggered by various regimen developments over the last decade, in the effort to provide women with a medical alternative to surgical abortion were used as resources for discussions.
Articles’ lists emerged from searching the above-mentioned databases were compared and overlapping articles were included in the final list of screened articles. Articles specifically identified in either of the databases were added to the final list. A total list of 160 articles was developed. Applying the inclusion and exclusion criteria, 5 articles matched the research question. As a main feature, I noted that the acceptability issue was not approached at all in some studies identified by the electronic search or was very little discussed, usually in one or two phrases. These articles were still retrieved from the databases, depending on the text words “mifepristone” and “misoprostol”.
3.3. Description of studies
1. Winikoff B. Acceptability of medical abortion in early pregnancy (25)
The study is a review summarizing data on acceptability of medical abortion collected by 12 different studies between 1979 and 1993. Among the reviewed studies, there are differences in study designs in terms of comparison groups (3 studies do not have a surgical group), patient recruitment methods (random allocation or patient voluntary choice of method), medical regimen protocols (either mifepristone alone, or mifepristone with a different prostaglandin), number of visits required by the study protocol (between 2 to 7 from one study to another), and the gestational age (up to 7, 8 or 9 weeks, but the surgical arm of one study included pregnancies up to 12 weeks). The author included in the review a small study of menstrual regulation with mifepristone. (see Table 1).
As a general observation, most of the comparative studies reviewed by Winikoff comprised small sample sizes (less than 100 cases per medical and surgical samples, respectively). The methods used to measure patients’ acceptability/ satisfaction was not reported in the review.
|Study||Sample size||Interventions||Treatment allocation method||Gestational age||Number of visits|
|Rose et al, 1979, Sweden||60||VA or
|randomization||< 56 days||≥3|
|Rose et al, 1984, Sweden||53||VA or
|randomization||< 49 days||≥ 2|
|Hill, 1990, England||100||mifepristone + gemeprost supp||patient choice||< 63 days||5|
|Tang, 1991, Hong Kong||42||VA or
mifepristone + prostaglandin supp
|patient choice||< 49 days||2
|Urquhart, 1991, Scotland||91||VA or
mifepristone + gemeprost supp
|patient choice||< 63 days||3
|Legarth, 1991, Denmark||50||VA or
|randomization||< 42 days||3|
|Holmgren, 1992, Sweden||128||VA or
mifepristone + gemeprost supp
|patient choice||VA 9-12 wks, 5-8 wks
|Bachelot, 1992, France||391||VA or
mifepristone + sulprostone inj
|patient choice||< 49 days||3-4
|Grimes, 1992, USA||16||mifepristone or placebo, without pregnancy test||randomization||< 42 days||4|
|Thong, 1992, Scotland||180||mifepristone + gemeprost supp or oral misoprostol||treatment allocation not reported BUT randomization to hospital or home treatment||< 63 days||5|
|Tang, 1993, Hong Kong||144||VA or
mifepristone + prostaglandin supp
|patient choice||< 49 days||2
|Henshaw, 1993, Scotland||99
mifepristone + gemeprost supp
|< 63 days||2
2. Winikoff B et al. Safety, efficacy and acceptability of medical abortion in China, Cuba and India: a comparative trial of mifepristone-misoprostol versus surgical abortion (27)
The study aim was to assess how acceptable is medical abortion in a trial that allows a woman to select her method (medical or surgical) and if the mifepristone-misoprostol regimen would work well and be acceptable in a developing country. Arguing that randomized controlled trials do not allow formal inferences to a population that has a choice of methods in the real service setting, and considering that an abortion patient must be prepared and willing to undergo an entirely different treatment if she wishes to avoid surgery, the study design chosen by the authors permitted eligible women for either method – as would be necessary for random design – to choose their own method. Inclusion and exclusion criteria are mentioned in the article. In all three-study sites, a total number of 799 eligible women chose to be enrolled in the medical arm of the study and a total of 574 eligible women selected the surgical method. Medical protocol consisted of 600 mg mifepristone at the first visit, followed by 400-mcg oral misoprostol 48 hours later, and a follow up visit scheduled after 14 days. Study staff ensured patient return to the clinic with home visits. Follow up for patients failing to present themselves at the clinic for the protocol-required visit included surgical abortion when required. Patient enrolled in the surgical arm of the study received the standard protocol procedure according to local practices in each of the three countries. Study data collection instruments were standardized questionnaires applied at every visit to the hospital (questions covered the procedure received, medication administered and side-effects and problems occurred during visits) and patient diaries (recording blood loss, cramps, fever, nausea and passage of tissue). Data was collected for any event outside the recommended protocol (unscheduled visits, additional abortion procedures). Exit interviews at the discharge visit recorded woman’s assessment of the abortion experience.
3. Slade P et al. A comparison of medical and surgical termination of pregnancy: choice, emotional impact and satisfaction with care (28)
The study investigated whether medical and surgical abortion patients differ before and after the abortion in terms of emotional distress. Also, evaluation included issues as whether genuine choices of method were available to women, what motivates different choices and whether choice was associated with differences in pre- or post abortion emotional state, satisfaction with care, and future preference for an abortion method. Inclusion and exclusion criteria are mentioned in the article. Women included in this study were offered or recommended (by medical staff) the choice of abortion method for fetal abnormalities. Although the medical abortion protocol is not specifically nominated in the article, reference is made to prostaglandins when mentioning the timing of the subject recruitment and pre-abortion assessment. Study intervention comprised the pre abortion assessment through an interview and the post- abortion assessment carried out four weeks after the termination through a questionnaire mailed to study participants. The pre-abortion interview explored the patient characteristics, the issue of choice between the abortion methods, the factors determining and the strength of preference for the choice, the symptoms of anxiety and depression (using the Hospital Anxiety and Depression scale, a 14 points scale measuring anxiety and depression, and the Positive And Negative Affect Scale, a 20 points scale measuring wellbeing through positive emotions and negative emotions experienced). The post- abortion assessment included the same emotional measures for anxiety and depression administered before the procedure and the Impact of Event Scale (a 15 points scale measuring subjective distress relating to a specific event) and the Satisfaction with Care Scale (a 8 points scale assessing whether needs were met during clinical services received and whether they would recommend the services to a friend). Qualitative information regarding choice was analyzed by the categorical approach.
4. Ngoc NTN et al. Safety, efficacy and acceptability of mifepristone-misoprostol medical abortion in Vietnam (29)
Given the few mifepristone-misoprostol acceptability studies conducted in developing countries, and considering women’s perceptions of the method critical to its acceptability, the authors explored the acceptability of the mifepristone-misoprostol regimen in women attending two clinics in Vietnam. Study design was selected to allow women to choose the medical or surgical abortion method. Study eligibility criteria are presented in the article. 260 women chose the medical abortion and 133 chose the surgical procedure. Medical protocol consisted of 600 mg mifepristone at the first visit, followed by 400-mcg oral misoprostol 48 hours later, and a follow up visit scheduled after 14 days. Backup surgical abortion was provided to women experiencing medical method failure. Women in the surgical arm of the study received the standard procedure according to local clinical protocols (nearly all vacuum aspiration with local anesthesia in one clinic and with no anesthesia in the other clinic). Follow up visit for surgical clients were scheduled 14 days after the procedure.
Study data was collected through exit interviews at the follow up visit. Questionnaires included data on procedures, medications, side effects or problems and reactions to the abortion experience. Data on side effects and timing of possible pregnancy expulsion was collected also through patients’ dairies. Women having previously had surgical abortions were asked to compare the current abortion experience with the previous one.
5. Jensen JT et al. Acceptability of suction curettage and mifepristone abortion in the United States: a prospective comparison study (30)
In the context of lack of evidence on the acceptability of mifepristone-misoprostol abortion in the United States (mifepristone being at that time under registration with the Food and Drug Administration Agency) and the particular political environment regarding abortion, the authors attempted to better understand the relative acceptability of medical abortion. The study compared outcomes of a subset of the Population Council’s U.S. mifepristone trial with the outcomes in a group of subjects undergoing surgical abortion managed at the same site. Eligibility criteria and subject recruitment are referred to the larger Population Council’s U.S. mifepristone trial. There were 178 women undergoing medical and 199 surgical abortion. The study protocol is described as follows: vacuum aspiration for the surgical arm and 600 mg mifepristone followed by 400 mcg oral misoprostol 48 hours later for the medical arm. Follow up visits were scheduled for both medical and surgical clients 3 weeks after the procedure. Pain relieve was provided to all women. Study data were collected through self-administered questionnaires at the first visit prior to the procedures and at the follow up visit. Data collected at the first visit referred to demographic characteristics, reasons for having the abortion and expectations for the abortion experience. Follow up questionnaire assessed data on actual abortion experience (overall satisfaction, future choice of an abortion method, recommendations of the method to a friend). Comparisons between expectations and experience were elicited on discomfort, anxiety and bleeding (on a 5 points scale). Management of continuous bleeding, retained tissue and ongoing pregnancy, as well as the definition of the medical method failure are presented. Statistical data analysis and comparisons made are presented in the article.
An overview on study type, sample sizes, study interventions, methods and timing of measuring the acceptability/satisfaction and intervention outcome are presented in Table 2.
|Author(s)||Study type||Sample size||Interventions||Methods for acceptability/satisfaction measurement||Timing of
acceptability / satisfaction measurement
incl. 12 studies
|see table 1||see table 1||VA1 vs mifepristone or mifepristone +prostaglandin/ gemeprost/ sulprostone/ oral misoprostol||not reported||treatment visit(s)
follow up visit(s) (variable number of visits between studies)
|medical abortion acceptability|
|Winikoff et al, 1997||Cohort||299 China
600 mg mifepristone + 400 mcg oral misoprostol
|3 point scale for satisfaction
future choice of method
follow up visit (2 wks)
|medical abortion safety, efficacy and acceptability|
|Slade et al, 1998||Cohort||132||143||Medical vs surgical abortion||5 point scale for preference for the procedure
HAD2 and PANAS3 scales for anxiety and depression prior to and after abortion experience
IES4 and SCS5 scales after abortion
4 point scale for stress
visual analogue scale for pain, bleeding, activity disruption
future choice of method
|treatment visit(s) preabortion interview
follow up visit (4 wks)
|choice, emotional impact and satisfaction with care|
|Ngoc et al, 1999||Cohort||260||133||VA1 vs
600 mg mifepristone + 400 mcg oral misoprostol
|3 point scale for satisfaction
future choice of method
recommendation of method
comparison with previous abortion
best and worst characteristics of the method
|Follow up visit (2 wks)||medical abortion safety, efficacy and acceptability|
|Jensen et al, 2000||Cohort||152||174||VA1 vs
600 mg mifepristone + 400 mcg oral misoprostol
|5 point scale for discomfort, anxiety, bleeding (expectations, experience, overall satisfaction)||treatment visit(s) preabortion interview
follow up visit (3 wks)
|acceptability of suction curettage and medical abortion|
Legend: 1 – Vacuum aspiration 2 – Hospital Anxiety and Depression 3 – Positive And Negative Affect Scale 4 – Impact of Event Scale 5 – Satisfaction with Care Scale
3.4. Methodological quality of included studies
1. Winikoff, 1995
The author points out the limited direct evidence on medical abortion due to the lack of trials conducted in the USA and addresses acceptability research for abortion methods in general. General introduction to acceptability is given and previous research attempts to identify acceptability attributes are referred to. Factors influencing medical abortion acceptability are discussed (i.e. medical regimens developed over the previous decade, techniques’ intrinsic characteristics, service delivery environment). Subject enrollment and randomization in a study are commented with a specific approach to acceptability studies, with an emphasis on generalization of study findings to broader population. Comparisons are considered somehow limited in terms of choice and acceptability of a new method against an established one. 12 published acceptability studies are presented and sample sizes, subject allocation, eligibility criteria and medical abortion regimens are critically assessed, pointing out the differences in study methodology. Despite the great variations in protocols, the author concludes the reviewed studies provide clear general conclusions about factors affecting the acceptability of medical abortion services because of the strong consistency in their findings.
2. Winikoff et al, 1997
The authors argue that randomized controlled trials are not a suitable design for acceptability studies and present the rationale of selecting a study design based on patient choice between the two abortion methods. Enrollment and method selection differences between the three sites are described. Sample sizes in both study groups included approximately 250 subjects, except for the surgical arm of the study in India (57 subjects). Eligibility criteria for study subjects are presented. Medical and surgical abortion protocols are described. Data collection instruments and data analysis are described. There is a possibility that selection bias had occurred in China and Cuba for women assigned automatically by the providers to the surgical arm because they could not decide which procedure to choose. Method failures were defined for both methods (acceptability failures, medical failures and erroneous diagnoses of incomplete abortion or ongoing pregnancy followed by unnecessary surgical interventions). Acceptability was assessed by a 3 points scale for overall satisfaction and by future method choice. Data analysis was performed with appropriate methods. Statistical significance of study data is emphasized.
3. Slade et al
Inclusion criteria were confined to fetal abnormalities as a reason for terminating a first trimester pregnancy, which are presumably infrequently found in the general population, as well as exclusion criteria represented by a small number of reasons (age less than 16, assaults resulting in pregnancy). Sample sizes in both groups are over 100 women (132 for the medical and 143 for the surgical arm). Acceptability and satisfaction measurements included appropriate scales for pain, bleeding, activity disruption, stress, preference for the procedure, anxiety and depression prior to and after abortion experience, impact of the event and satisfaction with care, including future choice of method. Data analysis was performed with appropriate methods. Statistical significant differences between the two methods are shown.
4. Ngoc et al
Subject recruitment and allocation are based on women’s choice, authors arguing on the little relevance of the randomization in the case of acceptability studies, but admitting that drawbacks of this design is that safety and efficacy data can be generalized only to women who choose between the methods. Sample size comprised 260 medical subjects and 133 surgical subjects. Eligibility criteria, surgical and medical abortion protocols are described in the article, including management of medical abortion failure. Patient satisfaction, including future choice of abortion method and recommendation of method to a friend are evaluated. Comparisons between the current and previous abortion experiences are provided.
5. Jensen et al
Subject recruitment for the medical arm was voluntary, potentially in connection with the novelty effect (since they decided to seek out a generally unavailable method and enroll in the study as research subjects). Presumably, all medical subjects rejected the surgical method to participate in the mifepristone trial. However, women enrolled in the surgical arm were not offered a choice (they were prospectively enrolled in the study as they were receiving the standard surgical procedure while the medical method was no longer available in the clinic). The authors acknowledge the lack of choice for the surgical group and may have biased the results of acceptability in favor of medical abortion. Sample size included 178 medical clients and 199 surgical clients. Women in this study complied with the eligibility criteria described in the larger Population Council mifepristone trial. Medical and surgical protocols are described, including procedures and pain medication received management of prolonged bleeding and abortion failures. Women were asked to rate their discomfort, anxiety, bleeding (expectations, experience) and overall satisfaction on a 5 point scale. Data were adequately analyzed and statistical significance of the differences between the two methods was underlined.
1. Winikoff, 1995
Studies reviewed by the author that had no surgical comparison group, those with very small sample sizes (i.e. total sample size of 42 subjects) were excluded from this review (4 studies). Furthermore, a study in which the design allowed medical clients to choose the method but surgical clients were not offered this choice was excluded. A study on menstrual regulation with mifepristone was also excluded as it did not meet the inclusion criteria for this review.
a. Rose et al, 1979
Only patients with complete abortion were evaluated. Failure as a reason for method dissatisfaction was not registered and differentials in success rates were not analyzed as reasons for preferring one method to another. Prostaglandin method was preferred by far before the abortion (numbers not reported) and received higher ratings after the procedure completion. Method ‘naturalness’ and privacy were appreciated, while pain, bleeding and treatment duration were disliked. Surgical patients showed a sharp increase in acceptability after treatment.
b. Rose et al, 1984
Medical abortion was chosen by 84% of the study subjects. Success rates were 100% for surgical and 97% for medical abortion. Medical patients did not change their positive attitudes toward medical abortion after receiving the procedure (even if 45% of the cases needed analgesic injections), and vacuum aspiration clients were much more positive about surgical abortion after treatment.
Future preference for the same abortion method used was slightly stronger in the medical clients as compared to surgical clients (75% vs. 68%), as was the preference for the method not used (16% vs 13%). Reason for switching the preference after treatment included pain, amount or duration of bleeding, length of the procedure. 31% of the surgical clients preferred medical method after surgical treatment for naturalness, fewer infection risks, and no hospitalisation. Surgical clients preferring surgical method did so because it is quick, simple and painless.
c. Tang et al
Sixty-nine percent of the study subjects chose medical abortion for reasons of fear of surgery (81%), fear of general anesthesia (11%), fewer traumas (21%), and convenience for work (41%).
31% of women chose surgical abortion, mostly because it was quick and convenient (82%), to avoid the number of visits or the length of medical abortion (69%) or because they were worried about drug efficacy and side effects (11%). Medical clients stated their future preference for a medical abortion (85%), including 12 women in whom the method failed. Medical clients with previous surgical abortion experience said they preferred medical abortion. Lengthy procedure (11%) and too much bleeding (10%) were complaints about the medical method.
d. Legarth et al
Mifepristone patients reported more persistent and intense pain and more prolonged bleeding than surgical clients (no numbers reported). Both groups rated their method as acceptable, with a “more positive evaluation” in the medical group (no numbers reported). Pelvic infection rates were unusually high in the surgical group (3 in 25 patients) and 3 out of 6 medical clients undergoing vacuum aspiration for medical method failure. Even with such high complication and failure rates, the method was found “acceptable” (no numbers reported).
The great majority of women both in medical and in surgical group (87% and (88% respectively) found the experience of their chosen abortion method positive. Medical clients reported more pain and bleeding than surgical clients (no numbers reported). Most women in both groups expressed a future choice for the same abortion method received (70-80%).
f. Bachelot et al
Medical abortion was the most frequently method chosen (59%), followed by vacuum aspiration with local anesthesia (31%) and vacuum aspiration with general anesthesia (11%). Women’s characteristics per method chosen seemed to be related to educational level, socioeconomic status and ethnicity (although no numbers were reported in the review). For choosing the medical method, the reasoning was as follows: method newness, efficacy and less invasiveness, visualization of the expulsion, naturalness (no numbers reported). The choice for surgical method was motivated by guarantees of precautions and method proven reliability (no numbers reported). Possibility of failure was less important among those who chose the medical method and avoidance of physical trauma was less important among those who chose vacuum aspiration under local anesthesia. The majority of women were satisfied with the chosen method, but medical clients were more likely to be dissatisfied than surgical clients (12% vs. 4%) because the abortion was not so “easy and quick” as it was expected to be.
g. Henshaw et al
40 % of the women who chose surgical abortion believed medical abortion was “too slow”, 39% preferred to be unconscious during the procedure and 23% were afraid of the medical procedure side effects. Women choosing medical abortion were afraid of surgery or anaesthesia (59%), felt medical abortion was more natural (21%) and believed that surgery was “too fast” (21%). Future choice of method was high for the same method received (95% for medical abortion and 90% for surgical abortion). Patients who were randomised expressed preference for the same method (74% for medical clients and 87% for surgical clients), but less than those who had a choice for the respective method. Acceptability was lower in the medical group with pregnancies over 50 days.
2. Winikoff et al, 1997
Patient characteristics are presented in Table 3.
|Mean height (cm)||162.3*||161.5*|
|Mean education (yrs)||12.8*||12.4*|
|Mean gestational age (wk)||5.5**||6.2**|
|Previously aborted (%)||70.6**||56.7**|
|Mean height (cm)||162.8*||162.0*|
|Mean education (yrs)||13.6**||12.6**|
|Mean gestational age (wk)||6.5**||7.1**|
|Mean education (yrs)||10.4*||9.1*|
|Mean gestational age (wk)||6.6*||6.8*|
* p ≤ 0.05
** p ≤ 0.001
Medical abortion acceptability failures rated 4.3% in China, 2.0% in Cuba, and 2.4% in India.
The overwhelming majority of all women, regardless of the method, were either satisfied or highly satisfied with the experience (China 94.3% medical vs 95.9% surgical –not significant- , Cuba 83.5% vs 93.5% - p £ 0.001 – India 95.2% vs 100% - not significant.
Women who chose medical abortion were significantly more often highly satisfied than were women who chose surgical procedures. (see Table 4).
When asked if they would choose the same method again if they needed another abortion the majority of them answered yes. In all countries, however a higher percentage of medical clients would do so, comparing to surgical clients. This difference was significant in China and India (see Table 4).
|Highly satisfied (%)||42.8*||23.1*|
|Not satisfied (%)||5.7*||4.1*|
|Highly satisfied (%)||59.0*||39.4*|
|Not satisfied (%)||16.5*||6.5*|
|Highly satisfied (%)||68.5**||54.4**|
|Not satisfied (%)||4.8**||0.0**|
|Would choose method again|
|India (%)||96.0 §||89.5 §|
* p ≤ 0.001
** p ≤ 0.01
§ p ≤ 0.05
3. Slade et al
Comparisons of demographic characteristics between the two groups indicated that those women undergoing medical termination had higher education and were more likely to be in a relationship that continues after the abortion (see Table 5).
There was a difference in gestation between the medical and the surgical groups with means of 6.9 and 9.9 weeks respectively (p < 0.001). Comparisons made among the surgical group between those over 9 weeks and those less than 9 weeks of gestation showed no statistical significant difference on any measure. No statistically significant associations were found between duration of gestation and any pre- or post-termination emotional or satisfaction measure for the surgical group.
Waiting time from the decision to terminate de pregnancy and the actual procedure was significantly longer in the surgical group compared to the medical group (means of 18 and 8.4 days respectively, p < 0.001).
|GCSE or equivalent||47||55|
|A levels or equivalent||35||31|
|In a relationship continuing after TOP||0.02|
|Weeks of gestation at TOP||6.9 weeks||9.9 weeks||0.001|
|Presence of previous TOT||36||43|
|No. of living children||2.0||2.2|
Emotional measures comparisons
Before termination there were no differences in the initial levels of anxiety or depressive symptoms (HAD scale) or patients affected (PANAS scale) (see Table 6).
|Negative affect (PANAS)||29.5||29.8||0.79|
|Positive affect (PANAS)||21.0||21.3||0.72|
At follow up there were no differences on the emotional measures (see Table 7).
Table 7. Emotional measures for the medical and surgical samples four weeks after TOP (mean SD)
(HAD = Hospital Anxiety and Depression, PANAS = Positive And Negative Affect Scale, IES = impact on event scale)
|Negative affect (PANAS)||23.1||23.6||0.68|
|Positive affect (PANAS)||27.3||27.3||0.95|
|Impact on events (intrusions, IES)||14.1||15.0||0.43|
|Impact on events (avoidance, IES)||15.9||18.1||0.10|
|Satisfaction with care||25.8||25.8||0.95|
Satisfaction with care
There was no significant difference between the groups in satisfaction with care (see Table 7). However, there were a considerable number of differences in how the termination was experienced (see Table 8). The medical group rated the termination process as more stressful and painful and they bled more. A greater proportion in the medical group (44%) than the surgical group (15%) reported that normal daily activities were significantly disrupted.
|Stressfulness of experience||2.4||2.2||0.05|
|Pain on the day||5.1||3.6||0.0001|
|Distress form pain||4.4||3.4||0.018|
|Days of bleeding||3.4||2.6||0.0001|
|Heaviness at worst||3.3||2.5||0.0001|
|Heaviness on average||2.4||1.9||0.01|
|Distress from bleeding||2.1||1.8||0.019|
|Bleeding more than expected||2.5||2.2||0.02|
|Disruption of activities||45||16||0.001|
Choice of method
In general, for those having a choice, being provided with this choice of methods was seen as “extremely important” by the majority of both of these samples (medical “quite important” 29% and “extremely important” 63%; surgical “quite important” 13% and “extremely important” 79%).
There were no significant differences in the emotional variables either before of after the abortion or in overall satisfaction with care between those who could choose and those who could not.
Reasons for choosing the medical abortion were to avoid anesthesia (61%) simplicity and ‘naturalness’ of the method (32%). Surgical procedure was chosen to avoid awareness and involvement in the abortion process (49%) pain-related concerns (16%) and emotional impact (16%) of the medical termination. Advice or reports from doctors or friends contributed to method choice for 11% of medical clients and 14% for surgical clients respectively.
As for future choice of methods, 92% in the surgical group opted for the same procedure, while only 53% in the medical group would make the same choice. The main reasons for changing from medical to surgical abortion under general anesthesia were stressful, shocking or unpleasant experience (1/3 of medical clients), less pain during or after the abortion (1/4 of medical clients) and the wish to avoid seeing the fetus (18%). The other reasons mentioned were that surgical abortion under local anesthesia would avoid seeing the fetus (18%), take a shorter time (41%), would be less distressing (24%) and would involve fewer chemicals (18%).
4. Ngoc et al
Demographic characteristics showed differences between the medical and the surgical group in terms of age, height, education, gestational age, marital status and contraceptive use (see Table 9).
|Mean height (cm)||155.8||154.5**|
|Mean education (yrs.)||11.6||10.6**|
|Mean gestational age (wks.)||5.9||6.1*|
|% married/in union||73.1||84.2*|
|% who had used contraceptives||37.7||58.6***|
* Difference between medical and surgical abortion patients is significant at p=<.05
** Difference between medical and surgical abortion patients is significant at p=<.01
*** Difference between medical and surgical abortion patients is significant at p=<.001
Reasons for method choice
Women who selected the medical method did so to avoid pain (59%) or surgery/anesthesia (43.4%), because they believed it was safer (40%) and less traumatic (30%). Women could name up to 3 reasons for method choice.
Women chose surgical abortion because they perceived it as simpler and faster (68%), more effective (64%) than medical abortion, safe (47%), convenient (26%) and involved fewer visits to the hospital (28%).
According to participants' diaries, 82% of medically induced abortions took place on the day the women received misoprostol, and 8% took place throughout the next two weeks. However, 10% of medical abortion patients did not recognize when their abortions occurred.
Most medical patients could identify where they were when the abortion occurred (even if they could not pinpoint the time of the abortion). Nearly three-quarters (72%) reported that their abortions occurred at the clinic and (20%) said theirs occurred at home. About 1% reported other locations, and the rest was unsure.
The vast majority of women were satisfied with their abortion experience--97% of those who had medical procedures and 95% who had surgical abortions. Of the 13 women who were not satisfied with the experience, five had method failures. Nevertheless, about half of the women who had failures remained satisfied with their abortions. A patient who had undergone a surgical intervention after the medical procedure failed, concluded that there was nothing wrong with the medical method, but that she was simply "unlucky”.
When asked about their experience during the study compared to their previous abortion experience, women who had medical abortions were significantly more likely than those who had surgical procedures to say that their study experience was more satisfactory (32% vs. 4%). Medical clients were less likely than surgical clients to report that the study abortion was not as satisfactory as their previous abortion (3% vs. 11%).
In the medical group, 95.7% and 51.6% in the surgical group would choose the same method again; 48.4% in the surgical group opted for medical abortion and 37.1% of them would also recommend it to a friend compared to 95.2% in the medical group that would recommend the method to a friend.
At their final visit, women were asked to describe the best and worst aspects of their abortion method. Each woman was permitted to give up to three answers. For medical abortion, the features most frequently cited were that the method is less painful than surgical abortion (35%), is safer (30%), does not involve surgery (20%) and is effective (14%). The emphasis on less pain is not surprising, given that surgical abortion is delivered with minimal anesthesia in Vietnam.
Prolonged heavy bleeding was most commonly reported as the worst feature of medical abortion (mentioned by 39% of women). A substantial proportion in the medical group (17%) also reported that the method involved too many visits and has a too lengthy follow-up. Some 30% of women who had medical abortions, however, were unable to offer any negative features of the method.
Women who chose surgical abortion clearly appreciated the method's effectiveness (46%), as well as the ease and simplicity of the procedure (23%). Yet 23% were unable to name any good characteristics of the method. Although women in the surgical group reported far less pain during the study compared to women in the medical group, 57% considered pain the method's worst feature. Surgical clients also included fear of surgery and mental stress among the worst features of the method.
5. Jensen et al
No significant differences existed between the medical and the surgical group with respect to age, mean gestational age, primigravity or prior pregnancy outcomes.
The experience with abortion related discomfort or anxiety tended to be less than expected in both groups, although there were no significant differences between the two groups. The medical group expected and experienced heavier and longer bleeding than did the surgical group. The mean experience for bleeding length exceeded the expectations in both groups, but there was no significant difference between these discrepancies.
Both methods of abortion were highly acceptable, but overall satisfaction with the procedure was higher in the medical group (mean satisfaction 1.42 vs 1.77, p < 0.01).
Regarding future choice of methods, medical abortion was preferred by 41.7% of surgical patients, while only 8.6% of medical clients preferred surgical abortion.
In the medical group, 97% and 93.3% in the surgical group would recommend the method experienced to a friend.
In the medical group, differences between expectations and experience with discomfort, anxiety or bleeding length did not influence satisfaction with the method or the likelihood of recommending either method. Only heavier bleeding than expected correlated with a significant reduction in satisfaction in women receiving the medical method.
Failure of the procedure decreased mean satisfaction among the medical group. No significant association with acceptability and failure was seen in the surgical cohort.
Many factors play a role in assessing the acceptability of medical abortion methods. Acceptability is an interaction among inherent quality of a method, the consumer’s personal values and perceptions of the attributes of particular products, and the service delivery system for the consumer.
While there are many studies (randomized clinical trials) researching mifepristone-misoprostol regimen safety and efficacy, acceptability issues are addressed very little. Some of these studies do not tackle at all women’s acceptability of the regimen under study, reporting only the technical acceptability from a scientific point of view, and some of them only state that the regimen “is acceptable to women”. Other studies investigate regimen acceptability on the basis of three questions, namely: “Where you satisfied with the abortion method?”, “Which method would you choose should you need another abortion in the future?”, and “Would you recommend the method to a friend?” With this limited approach, many studies reported the medical abortion acceptance as high (31, 32, 33, 34, 35, 36). A few studies dedicated to mifepristone-misoprostol acceptability from a woman’s perspective (37, 38) showed this method was highly acceptable to women and some other studies reported that women were confident enough to use the method at home (39, 40, 41).
The articles selected for this review looked more into detail to medical and acceptability issues, but none of them used in depth, qualitative approaches to explore patient expectations and experiences with the abortion method. The research methods and data collection instruments used were different. However some conclusions emerge form the study results published by the articles reviewed.
Acceptability of both medical and surgical abortion methods was high in all studies. All the studies showed that method choice is important to patients, and 4 out of 5 studies stated that patients who can choose between different methods have higher acceptance of the abortion experience. Method failure was a major reason for dissatisfaction in the medical group.
Specific reasons for selecting the medical method included naturalness, privacy, less invasiveness, desire to avoid surgery/anesthesia, and control over the abortion process. Specific reasons for choosing the surgical procedure most frequently mentioned were time considerations (the method was perceived as quick), easiness and simplicity, and the small number of visits to the hospital. Reasons cited by women in both samples were safety, efficacy, pain avoidance, and convenience.
The most frequent unpleasant experiences (pain, bleeding, duration until tissue expulsion) experienced by women in the medical group were overcome and did not adversely affect medical abortion acceptability.
The need for women’s counseling and education regarding medical and surgical abortion was emphasized in all articles as a means to facilitate informed choices and better prepare women for the actual abortion experience. Also, provider’s technical skills are important, since clinicians inexperienced with the medical abortion technique may be more likely to intervene surgically and add to “acceptability failures”.
- Acceptability is difficult to measure and standardize, because it depends on the values a person holds, the individual's perceptions of the attributes of particular products, and the service delivery system the consumer encounters.
- Both medical and surgical induced abortion is acceptable to women, especially to those who have exercised a choice of method.
- Safety, efficacy and pain control are major concerns influencing choice and the acceptability of the abortion experience in both surgical and medical clients.
- Method failure can result in dissatisfaction with the abortion procedure and can be a reason for not choosing the same method in the future or not recommend the method to a friend.
- For many women, induced abortion (medical or surgical) is an emotionally stressful event and proper information prior to the procedure can help to shape the expectations and overcome the experience.
- Method drawbacks (i.e. pain, bleeding, duration until expulsion) do not have a major impact on method acceptability, provided adequate information and medication is given to clients.
- Medical abortion regimens and protocols developed over the last decade have different drug combinations, dosages and routes, and administration schedules. This makes patient acceptability assessment even more difficult, since different clinical protocols may have an impact on patients’ attitudes and compliance with the method.
6.1. Implications for practice
Current literature review provides a body of evidence on acceptability studies carried out worldwide and a comparison basis for the study conducted at the East European Institute of Reproductive Health on this topic were 145 women underwent medical abortion and 178 women surgical abortion.
6.2. Implications for research
Given the limited number of studies addressing the mifepristone-misoprostol medical abortion regimen acceptability as compared to vacuum aspiration acceptability, future research efforts would need to assess more in detail and with a qualitative approach women’s needs, expectations and actual experiences, with a view to improve the quality of currently available technologies and service delivery.
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