An international study on the acceptability of a once-a-month pill
A.F. Glasier1,5,
K.B. Smith1,
L. Cheng2,
P.C. Ho3,
Z. van der Spuy4 and
D.T. Baird1
1 Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK
2 Shanghai Institute of Family Planning Technical Instruction, Shanghai, People's Republic of China,
3 Department of Obstetrics and Gynaecology, University of Hong Kong, Hong Kong, People's Republic of China, and
4 Department of Obstetrics and Gynaecology, University of Cape Town, South Africa
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Abstract
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Totals of 450 women attending family planning clinics in Hong Kong, Shanghai and Edinburgh, and 468 in Cape Town, completed a questionnaire designed to seek their views on a contraceptive pill which would be taken only once each month. At least two-thirds of the women in all centres liked the idea of a once-a-month pill. In Hong Kong, Cape Town and Edinburgh, women preferred a pill which inhibited ovulation to one which inhibited implantation, while in all centres a pill which worked after implantation (early menstrual inducer) was considered unacceptable by over half the women. A pill which was taken after a missed menstrual period was considered preferable in all centres, perhaps because it would not be used every month but rather only if pregnancy had occurred. No demographic characteristics, contraceptive experiences or beliefs were consistently correlated with attitudes towards a once-a-month pill, except that women who would not consider having an abortion were more likely to dislike a method that either prevented, or worked after, implantation. A once-a-month pill is now technically possible, although the major drawback is the need to determine when it should be taken. It is reassuring that many women from a variety of different cultures and with widely different experiences, would find this an attractive approach to contraception.
Key words:
contraception/contraceptive pill/mifepristone
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Introduction
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Contraceptive prevalence is increasing globally: 56% of couples in developing countries and 73% in the developed countries of the world were using contraception in 1995. With population growth, however, the number of contraceptive users will need to increase by 50% by the year 2025 even to maintain prevalence at the current level (World Health Organization, 1998
). In many countries, abortion rates are also rising. In developed countries, where contraception is easily available at minimal or no cost, roughly 50% of unwanted pregnancies arise from the failure of a method (usually less than perfect use), while 50% occur in women who have not used contraception (Griffiths, 1990
; Yimin et al., 1997
). Despite an apparently wide choice of contraceptive methods, many couples are either unable to find one that suits them, or they persevere with a method with which they are somewhat dissatisfied. Despite reassuring data on safety, many women are concerned about the long-term exposure to steroid hormones, believing the daily ingestion of hormones to be `unnatural' and unsafe (Oddens et al., 1994
). In 1991, a study was undertaken (Rimmer et al., 1992
) to assess the attitudes of women in three European countries (Scotland, Slovenia and Romania) to the concept of a pill which would be taken only once each month. Women were generally in favour, although the majority found the idea of a pill which acted after implantation to be unacceptable.
Since 1991, the development of a once-a-month pill has become feasible. In a pilot study (Gemzell-Danielsson et al., 1993
), it was reported that only one pregnancy occurred among 21 women who had taken a single dose of 200 mg mifepristone at midcycle during 124 cycles in which intercourse occurred during the fertile period.
In 1995, the UK Medical Research Council and Department for International Development jointly funded a programme of basic research in the development of new contraceptive methods in a network of centres in Shanghai and Hong Kong in China, Cape Town in South Africa, and Edinburgh in Scotland. Since one of the main areas of research was to be on the contraceptive effects of antigestagens, and recognizing that the acceptability of different methods of contraceptives varies widely in different cultural settings, it was decided to revisit the issue of the acceptability of a once-a-month pill in an international setting with widely disparate cultures and contraceptive practices.
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Materials and methods
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The questionnaire used in the previous study (Rimmer et al., 1992
) was revised to investigate the attitudes of women towards a once-a-month pill, the possible mechanism of action, and practicalities for use. A pilot version of the questionnaire was administered to 25 women at the Edinburgh centre, and the final version was prepared as a result of discussions with these women. The questionnaires were administered by trained interviewers who gave detailed explanations, with the aid of diagrams where appropriate. The questionnaire took approximately 1015 min to complete, and subjects remained anonymous. All questions were worded to allow a range of expression of opinions to be recorded, and a five-point Likert scale was used (Streiner and Norman, 1995
). The questionnaire was administered to 450 women attending clinics at a large family planning (FP) clinic in Edinburgh (The Dean Terrace Centre), to 450 women attending clinics of the Maternal and Child Health Centres in Hong Kong, and to 450 women attending clinics at the Shanghai Institute of Family Planning Technical Instruction. In Shanghai and Hong Kong, more than 97% of the respondents were Chinese, while in Edinburgh over 97% were of Caucasian origin. In Cape Town, a total of 468 women were interviewed at a variety of FP clinics selected to obtain equal numbers of the three main ethnic groups; black, coloured and white women (156 in each group). Within each setting all patients were invited to take part. The questionnaires were translated locally into Cantonese and Mandarin in Hong Kong and Shanghai respectively, and into Xhosa and Afrikaans for the Cape Town centre. During 1996, recruitment took place over 3 months in Edinburgh and Shanghai, and over 6 months in Hong Kong and Cape Town. Less than 10 women in Hong Kong and Shanghai declined to complete the questionnaire. In total, 162 women in Edinburgh, and 356 in Cape Town, declined to participate in the study. The over-riding reason was lack of time, but in Cape Town almost half the refusals were due to the patient speaking a different language from the interviewer.
Brief demographic data, details of previous contraceptive use and concerns about possible side effects of contraception were noted. The women were then advised that it was now technically possible to produce a pill to prevent pregnancy which need only be taken once monthly, and were askedin principlehow they felt about the idea. It was then explained that such a pill may act in one of three ways: by preventing ovulation; by preventing implantation; or by disrupting implantation. The acceptability of each method was recorded. The final question addressed how women would feel towards a pill which they would take only if their period was 23 days late. It was made clear that this pill would act by dislodging an early embryo, and that they would probably need to take such a pill only three or four times each year.
Statistical methods
The responses were coded and entered into databases at the individual centres and returned to Edinburgh for quality control checking and statistical analysis. The significance of associations between different variables was tested by
2, MannWhitney, KruskalWallis or Spearman rank correlation tests as appropriate. Multiple linear regression was used to test the effect on ordinal responses of several factors adjusted for one another, since the sample sizes were considered to be large enough to justify the normal approximations involved. The complete range of five-point Likert scales was used for significance testing, omitting those who did not know, but the percentages of women quoted as having `positive' attitudes in the results refer to the combined numbers of those who were positive or very positive as a percentage of all women, including those who responded as `don't know'.
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Results
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Demographics of sample
The demographic characteristics of the women who took part in the study are shown in Table I
.
Women in Edinburgh and Cape Town were similar in age, marital status and smoking habits. Some 65% of women in Edinburgh had never been pregnant, compared with 48% in Cape Town. In Hong Kong and Shanghai, where family planning clinics are used almost exclusively by married women, over 90% of women were parous. A history of induced abortion was most common in Shanghai (68%) and least likely (at least to be admitted to) in Cape Town (1%), where at the time of the study abortion, although officially legal, was extremely difficult to obtain. There were major differences in past contraceptive use between the centres (Table II
).
Attitudes towards the concept of a once-a-month pill
In all centres more than two-thirds of women were in favour of the concept of a once-a-month pill (Table III
). Womens' attitudes were independent of any of the demographic variables listed in Table I
or, in Edinburgh, by past use or beliefs about contraception. In Hong Kong, women who had used the oral contraceptive pill in the past were more likely to be positive (P < 0.05), while in Shanghai women under 25 years of age (P < 0.025), and in Cape Town women over 25 (P < 0.05), were more likely to be positive to the concept.
Mechanism of action of a once-a-month pill
Attitudes towards a once-a-month pill differed according to the mode of action (Table IV
). There were no consistent factors which correlated with womens' preferences. In Shanghai, women who were better educated (P < 0.025) and older (
30 years of age) (P < 0.001) were more likely to be positive about a pill which inhibited ovulation. In Cape Town, white women were more in favour of a pill which inhibited ovulation, regardless of their educational level (P < 0.001). Among black and coloured women there was a weaker correlation between educational achievement and preference for a pill which inhibited ovulation.
In Edinburgh, Cape Town and Hong Kong, acceptability of the method was much less if a pill was designed to inhibit implantation, with the greatest decline being in Edinburgh (Table IV
). In contrast, in Shanghai women found a pill which inhibited implantation more acceptable (78% positive) than one which inhibited ovulation (65% positive). In Edinburgh and in Hong Kong, the difference in acceptability of the method according to whether it inhibited implantation or ovulation was influenced by knowledge or beliefs about the mechanism of action of existing methods commonly believed to inhibit implantation, such as the intrauterine device (IUD). Women in Hong Kong who found an IUD an acceptable method were more likely to be positive towards a pill which prevented implantation (P < 0.001), while in Edinburgh women who said they were unaffected by the way in which contraceptive methods worked were more likely to be positive (P < 0.01), and women who disapproved of emergency contraception were more likely to be negative (P < 0.001). In South Africa, a pill which inhibited implantation was more likely to be favoured by black women (P < 0.05) than by white or coloured women.
Acceptability declined in all centres, especially Shanghai, if the pill was said to dislodge an embryo which had already implanted (Table IV
). Approval of this method was significantly related to approval of IUD use (P < 0.001 in Hong Kong and P < 0.001 in Cape Town) and neutrality about the mode of action of any method (P < 0.01) in Edinburgh. Attitudes towards abortion also correlated with attitudes towards the mode of action of a once-a-month pill which dislodged an embryo. In Hong Kong, women who would consider having an abortion if they had an unplanned pregnancy were more likely to be positive (P < 0.001), while women who would not consider an abortion were likely to have a negative attitude in Edinburgh (P < 0.001) and Cape Town (P < 0.05). In Shanghai, there was no effect of views on abortion. In Cape Town, white women (independently of their level of education) were least likely to approve of a method which dislodged an already implanted pregnancy (P < 0.001). Those coloured women who had received more years of education were also not in favour of this method (P < 0.01).
Missed-period pill
Women were asked how they felt about using, as a regular method of contraception, a pill which was taken only if a period was missed. No other contraception would be used and (based on estimates of fecundability) women were informed that their period was likely to be late only three or four times a year. In Hong Kong and Cape Town, 44% of women were positive towards this idea (Table III
). In Hong Kong, women were more positive if they were older (P < 0.05), less well educated (P < 0.001) and happy to use an IUD (P < 0.001). In Cape Town, in contrast, older women found the idea less acceptable (P < 0.05), but single women were more positive (P < 0.05), as were black women (P < 0.01). In Edinburgh, where only one-third of women found relying on an abortifacient acceptable, single women (P < 0.01) and those whose views were unaffected by the mechanism of action of any method (P < 0.05) were most likely to be positive. In Shanghai, where only 9% of women were positive, women who were separated were more likely to approve (P < 0.05) than those who were married or co-habiting.
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Discussion
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Despite vastly different cultures, beliefs and experience with contraception, women in China, South Africa and Scotland do not differ substantially in their attitudes towards a pill which needs to be taken only once a month. In all centres more than two-thirds of the women who were asked thought that the idea was a good one. Attitudes towards how such a pill might work were also surprisingly similar. In all centres except Shanghai, most women would prefer to use a method of contraception which inhibited ovulation rather than one that inhibited implantation. This preference is likely to reflect personal views about the niceties of the stage in development when conception is interrupted. Indeed, women who expressed prejudices about the mechanism of action of a contraceptive method were consistent in the pattern of approval and disapproval. In Shanghai, hormonal contraception is not widely used (only 16% of women in this study had ever taken the oral contraceptive pill). It is commonly held that interference with the menstrual cycle leads to `hormonal' side effects including obesity and hirsutism. It is possible that these beliefs explain the preference for a pill which inhibits implantation.
In all centres women expressed a strong dislike of a method which dislodged an already implanted embryo. Interestingly, on this issue the two Chinese centreswhere abortion was most commonheld the most extreme views, with over 90% of women in Shanghai disapproving of a pill acting after implantation compared with only 51% in Hong Kong. This observation is difficult to explain. While it may seem paradoxical that women might find a missed-period pill more acceptable than a pill which dislodged an embryo, it is possible that women might dislike a method which intentionally aimed to dislodge an embryo every month and may be more pragmatic or fatalistic about taking action after a pregnancy had actually occurred. These findings are in contrast to the suggestion that expected menses inducers (EMI) are more acceptable than missed menstrual inducers (MMI) (Harrison and Rosenfield, 1996
). There was some consistency in womens' attitudes, as those who would not consider an abortion under any circumstances were most positive about contraception which prevented ovulation, and were increasingly negative about intervening as the stage of pregnancy advanced (Table V
).
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Table V. Percentages of women positive towards different methods of contraception in each centre according to whether they would or would not consider an abortion. Results from Shanghai are excluded as only one woman would not consider abortion
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Despite overall similarities, demographic differences might be expected to cause some minor variations in views. Women in the two Chinese centres, almost all of whom were married, were much less likely to consider changing their current method of contraception than women in Scotland or South Africa. A similar degree of satisfaction with their current method was described among men in Shanghai and Hong Kong who took part in a questionnaire study about male contraception (C.W.Martin et al., personal communication). It is possible that contraceptive users in Shanghai have more faith in their doctors' advice than men and women in the West, where a tendency to question or actively disagree with figures in authority is more common.
Although different demographic characteristics correlated with different preferences in different cities, there was no one factor, or pattern of factors, which determined contraceptive choice. In general throughout their responses, women were consistent in the beliefs which they hold strongly, but even in South Africawhere ethnic differences might be expected to reveal marked contrasts in contraceptive preferencethere was no clear pattern of response (Table VI
). An individual's choice of contraceptive method is probably influenced by many factors, including past experience (of both contraception and reproductive events), technical or scientific knowledge, and beliefs about efficacy and side effects. Different methods suit different women at different times in their lives and given the choice, a once-a-month pill which acted before implantation would almost certainly be a well-used method of contraception. Our findings suggest that an EMI and MMI would probably be regarded as something of a last resort.
The results of this survey were not substantially different from those of the survey undertaken in 1991 which involved only European centres. Only in Edinburgh was the study repeated (in the same setting), and it is interesting to note that the percentage of women in favour of a once-a-month pill had increased from 72% in 1991 to 84% in 1996. There was also an increase in the number of women finding a missed-period pill an acceptable concept (24% in 1991 versus 32% in 1996). Perhaps this reflects a general liberalization of society's attitudes, and helps to explain the differences between Europe, Africa and Asia in the current survey.
If a once-a-month pill is to become available, it is likely that it will need to be taken at a precise time in the cycle. To do this, women will have to use a method of detecting ovulation, such as the measurement of luteinizing hormone (LH) in urine. It is likely that several tests will need to be done over a number of days, as accurate timing will be vital for the efficacy of the method. We asked the respondents whether they would be prepared to do this, and the results are shown in Table VII
. In all centres <15% of women would be prepared to test their urine as frequently as would almost certainly be required (56 days/month) if ovulation were to be detected reliably. A method of contraception is already available in the UK which requires urine testing for up to 10 days each month (Bonnar et al., 1999
). The methoda fertility regulation monitor known as Persona (Unipath, Ltd., Bedford, MK44 3UP, UK)is favoured by women who want to avoid using hormonal contraception. Given the option to use a method which exposes them to these drugs only 13 times a year, many more women may be prepared to endure the inconvenience of urine testing if the method were highly effective. With time, it may be possible to develop similar convenient monitors which measure indicators of ovulation in other, more acceptable fluids, such as saliva.
It is difficult to predict how many women would actually use a once-a-month pill were one to become available. Many other factors (e.g. related to compliance, cost, and provider acceptability) are involved in the process that leads to effective and safe use of a new contraceptive method. While it would be unwise to extrapolate precisely from the findings of this survey, the positive attitudes of so many women from such different cultures should nevertheless be reassuring to any pharmaceutical company interested in turning the concept into a reality.
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Acknowledgments
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The authors would like to thank the following staff for administering the questionnaires: in Edinburgh, Mrs Ann Mayo, Mrs Cathy Hall, Dr Fiona Grieve and Miss Wendy Smith; in Cape Town, Marion Heap, Nopasika Pinzi, Marianne Semenya, Marc Maurel, Steve Mussett, Miriam Velebayi and Anne Hoffman; in Hong Kong, Miss Sharon Lee; and in Shanghai, Dr Chuanliang Tong. We also thank Dr Rob Elton for statistical advice, Mrs Linda Lockerbie and Mrs Christine Maguire for data entry, and Mrs Audrey Duncan for typing the manuscript. The four centres in this study comprise the Contraceptive Development Network which is funded by the Medical Research Council and the Department for International Development (G9523250).
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Notes
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5 To whom correspondence should be addressed at: The Dean Terrace Centre, Edinburgh, Scotland 
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References
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Submitted on June 4, 1999;
accepted on September 20, 1999.