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Acceptability of a nonsurgical method to terminate very early pregnancy in comparison to vacuum aspiration
CONTRACEPTION
ACCEPTABILITY OF A NONSURGICAL METHOD TO TERMINATE VERY EARLY PREGNANCY IN COMPARISON TO VACUUM ASPIRATION Anne-Sofie Ros~n I , Lars Nystedt I, Marc Bygdemau 2 and Viveca Lundstr8m 2 IDepartment of Psychology, University of Stockholm, 2Department of Obstetrics and Gynecology, Karolinska Hospital, Stockholm, Sweden.
ABSTRACT Seventy-seven patients applying for abortion during early pregnancy consented to be treated by prostaglandin vaginal suppositories or vacuum aspiration by Kahrman catheter in a random design. They also consented to participate in an acceptability study of the two procedures. Attitude and preference measures were obtained by interviewing and rating scales on three occasions: before assignment to abortion procedure, immediately after treatment, and two weeks later. The first 50 patients with complete abortion by either procedure participated in the acceptability study. Both treatments were positively evaluated but perceived to have very different characteristics. The preference for the method used for own treatment increased iu both groups. Before treatment 1/3 of the patients in each group had a positive attitude to a selfadministered method to induce abortion outside clinics. This proportion increased significantly after treatment but only in the group that received prostaglandin by the vaginal route.
Accepted
for p u b l i c a t i o n
January
FEBRUARY 1979 VOL. 19 NO. 2
3, 1979
107
CONTRACEPTION
INTRODUCTION An increasing number of the therapeutic abortions are performed during early pregnancy. The methods mainly used at present are vacuum aspiration with Kahrmau catheter during the first weeks following the first missed menstrual period and with metal catheter during the later part of the first trimester. These procedures are very satisfactory in many respects but a nousurgical method could be an attractive alternative in some situations. A pharmacological method offers the obvious advantage of selfadministration on a day off at home and avoids the publicity in an abortion clinic. Some women may also prefer a treatment resulting in a menstrual-like bleeding instead of au operative procedure. The administration of prostaglaudin analogues seems to be useful for this purpose. Recently the results were published from a study of a randomized comparison between repeated vaginal administration of 16,16dimethyl-PGE9 and vacuum aspiration for termination of early pregnancy in'women with up to 56 days of amenorrhea (I). It was concluded in this report that both methods were equally effective but that vacuum aspiration was superior with regard to time, duration of bleeding and frequency of gastrointestinal side effects. An advantage of the vaginal treatment was its simplicity of administration and the possibility of self-administration. Such features of the uonsurgical method may for some women have outweighed the disadvantages noted in the comparison with the operative procedure. The present study was undertaken to explore the acceptability of the new uousurgical method iu comparison with vacuum aspiration to patients admitted to the hospital for termination of au early pregnancy. Acceptability refers to how the attributes of a method are evaluated by a person (2). The degree of acceptability can be assumed to influence his or her willingness or intention to use it. METHODS Patients Altogether 77 women in the 5th to 8th week of pregnancy (up to 56 days of amenorrhea) consented to be treated with prostaglandiu vaginal suppositories or vacuum aspiration in a randomized design. The patients had been admitted to the clinic by the regular procedure for abortion applicants. They were asked to participate in an acceptability study for evaluating treatment and only one patient refused. The patients were similar in background variables to others who apply for a termination of an early pregnancy at the hospital. Thirty-six women had one to three children (M=1.7). Six
108
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women were housewives, one was unemployed, 40 worked outside home and 13 studied. Nineteen women had had one or more therapeutic abortions earlier. The previous education varied among the patients, from 9 years compulsQry school to university degree. The data from the first 30 patients with complete abortion by either of the two methods were used for the acceptability study. Procedure for abortion treatment S e r u m HCG (human chorionic gonadotrophin) had been measured to ensure pregnancy in all cases before treatment. The efficacy of the treatment was judged by weekly measurements of haemoglobin (Hb) and HCG and by gynecological examination performed after two weeks or when clinically indicated. Prosta~landin treatment. Vaginal suppositories containing 16,16dimethyl PGE^ were given on four occasions at 3-hour intervals. The first tw~ suppositories contained 0.8 mg and were followed by two doses of I mg. The first three suppositories were inserted in the ward. The forth suppository was generally administered by the woman herself in the afternoon after returning home. The patients stayed in bed for one hour after the insertion but were permitted to ambulate freely for the two following hours. The patients were nursed and supervised by the nurses engaged by the WHO Clinical Research Unit at the Karolinska Hospital. Vacuum aspiration. Vacuum aspiration was performed with a Kahrman catheter, size 5 or 6, following an intravenous injection of diazepam and paracervical block with 20 ml 0.5 mg/ml prilocaiu chloride. Normally the patient stayed in the hospital for four hours. The operation was performed by one of two surgeons and the patients nursed by the regular operation ward staff at the Department of Obstetrics and Gynecology at the Karoliuska Hospital. Procedure for acceptability study: Observations were obtained for each patient on three occasions: I) immediately prior to t h e ~ r s t appointment with the gynecologist, who later assigned the patient to a treatment when pregnancy had been confirmed; 2) on the day of abortion before the patient went home after treatment; and 3) two weeks after treatment when the patient came back for the gynecological examination. Table I presents the plan for collecting observations by use of interview schedules and various rating scales. A female trained psychologist with considerable experience from clinical ana nonclinical interviewing was engaged for the data collection.
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1979 VOL. 19 NO. 2
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CONTRACEPTION
Table I. Schedule for the acceptability study. An X marks when an observation was made. The occasions were: I. before assignment to treatment; 2. after treatment, before going home; 3. two weeks after treatment. Observations
Occasions I 2 3
Knowledge of methods of abortion Preference of methods Reasons for preferences Attitude to self-administration Side-effects: expected ,' experienced Semantic ratings: of different methods of own treatment of personnel
X X X X X
X X X X
X
X
X X
X
On occasion I the interviewer asked the patient to report in her own words what she knew about clinical methods for inducing abortion. Ten questions were asked for each method named or described and the responses later used to assess knowledge of methods. The interviewer presented a typed, noutechnical description of abortion by prostaglandin suppositories, vacuum aspiration and dilation with curettage and read it aloud to the patient. Her preferences among the three methods, pairwise presented, were recorded and again on occasion 3. Her reasons for a preference were also recorded. The attitude towards performing a self-administered abortion by a pharmacological method with or without a previous contact with a clinic was assessed from interview questicus on occasion I and 3. The interview schedule contained questions about seven side-effects from the abortion methods: Pain, Bleeding, Infection, Fever, Tiredness, Nausea, and Diarrhea. The interviewer categorized the responses to questions about expected and experienced side-effects as Not at all, A little, Moderate, Very much. The patient rated amount of pain and bleeding from treatment as compared to normal menstruatiou. A five-point scale was used with a midpoint defined as 'the same as my usual menstrual pain' (or bleeding). Semantic ratings of abortion methods were made by the patient on 12 bipolar adjective scales with 7 points, e.g. the scale Good Bad. The general procedure for the semantic differential technique was followed (3). A set of semantic rating scales was also used by the patient to evaluate the personnel and the way she had been treated by them.
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RESULTS Clinical findings Vacuum aspiration and vaginal administration of 16,16-dimethyl PGE 2 were equally effective in the group of 77 patients. All patients with the exception of one woman in the surgically treated group aborted as result of the treatment. Abortion was complete in 95 per cent of cases for vacuum aspiration and 93 per cent for vaginal administration of prostaglandin. Bleeding generally started 2 to 8 hours from the start of the prcstaglandin treatment and continued for 10 to 14 days in most patients. The duration of bleeding was slightly shorter following the operative procedure. The means of the groups were 9.3 and 11.9 days. Occasional episodes of vomiting and/or diarrhea occurred in 9 of the prostaglandin treated patients. Injections of either peutazocine or mepiridine hydrochloride were given to 9 patients during prostaglandin treatment. Acceptability study No difference between the groups could be detected in background variables as age, number of childbirths and abortions, in educational and professional level. Nor were there any differences in their knowledge of how abortion is performed. In both groups vacuum aspiration was the least known procedure. Totally, 53 patients mentioned and/or described dilation with curettage, prostaglandin was mentioned 39 times, saline injection 26 and vacuum aspiration 24 times. The patients" preferences for methods before and after treatment were obtained from paired comparisons and scales (4). The scale values for three abortion methods were linearly transformed and referred to a common, arbitrary origin, defined as the value of the least preferred method in one group. Figure I illustrates the position of the three methods on a subjective continuum of preference, Rj, for the two groups. Two facts are evident from Figure I. Firstly, prostaglandin treatment was the most preferred method before abortion in both groups followed by vacuum aspiration and dilation with curettage. The preference was slightly more pronounced in the prostaglaudin group Secondly, after abortion this group was even more favorable to prostaglandin treatment than to the other methods. The other group changed their preference order and after abortion preferred vacuum aspiration over the other methods.
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1979 VOL. 19 NO.2
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CONTRACEPTION
Group PVS
( ~ =PVS (~=VA (~) = Cur
J
-o.
,Io
2'o
. Rj
Scale values by paired comparisons abortion
Group VA
D
Ri
After abortion
Fig. I. Subjective scales for three abortion methods in the two groups of patients. PVS denotes prostaglaudin suppositories, VA vacuum aspiration and Cur dilation with curettage. Positions of the methods before and after abortion on subjective continua of preference are indicated. Origin is arbitrary. The attitude to self-administered abortion without or with contact with physician or clinic chauged significantly in the prostaglandin group. Before treatment 10 women in each group affirmed that they would, without contacting a physician first, try a self-administered procedure at home if something like the prostaglandin suppositories was available. This figure increased to 17 in the prostaglandin group after abortion ( ~ for change = 4.00, df = I, P ~ 0 . 5 ) . In the other group there was no change in this attitude ( ~ for change = 0.33, df = I). The patients in the latter group who before treatment were favorable to a self-administrative procedure remained so. The pre- and posttreatmeut ratings of own treatment ou the semau±ic scales were analyzed by analysis of variance for repeated measures, separately for each scale, in order to explore how the abortion procedure was perceived by each group and how the evalus~ tions may have changed from treatment. Between group comparisons revealed that the ratings were significantly higher over the three occasions for the scales Easy and Fast in the group treated by the operative procedure and for Painful and Active in the prostaglandin group (Fig. 2). The prostaglandin vaginal administration had been positively evaluated by the patiauts before they had been assigned to be treated by this procedure. The mean ratings were above 5 on 7-point s c a l e ~ e.g. for Bad vs. Good, and Negative vs. Positive. The positive evaluations did not change from treatment experiences in this group. The only change noted was that posttreatmeut the patients rated the procedure as significantly more Calm aud Warm (Fig. 2). Before treatment the other group had rated vacuum aspiration in
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the midregion of each bipolar scale with the exception of a high rating for Fast. Posttreatment the ratings of vacuum aspiration had changed significantly in the positive direction on all scales except those referring to the swiftness of the procedure aud the level of activity and pain involved. These patients still perceived the procedure as very quick but rather passive and painless.
Dreadful- Calm P a i n f u l - Painles~
B a d - Good
i
Unpleasant - Plea:ant Negative - Positive F r i g h t e n i n g - Harmle:~s Unattractive
- Attractive
Cold - W a r m D i s a g r e e a b l e - Agreeable PaJslve - Active
Hard - Easy S I ow - Fa$ t Significant •
difference
Nonsignificant I
-3
I
-2
difference
i
i
i
i
i
-1
O
1
2
3
Difference scores
Fig. 2. Difference scores in ratings on semantic scales pre- and posttreatment. Each point of a profile indicates the mean difference on the scale in the prostaglaudin (PVS) and vacuum aspiration (VA) groups. Significant differences are indicated. All scales have the positive poles to the right. The interviewer scored the patieuts" responses to questions conceruing each side-effect as Not at all (=I) to Very much (=4). A three-way analysis of variance for repeated measures was performed of these ratiugs, one for ~a~h s ~ e - e f f e c t , aud some results are preseuted in Figure 3. The prostaglaudiu group had expected and experienced mere pain from treatment ~nan the vacuum aspiration group. In the two weeks following treatment there was no difference between the groups (Fig. 3). The groups differed significantly iu their reports of bleediug, subjectively reported to be much larger from prostaglaudin treatment. The interviewer's scoriug of the patients" responses to interview questious were consisteut with the p~tients" ewu ratings on five-point scales of pain and bleediug as compared to owu regular menstruation. Prostaglaudiu treatmeut was rated to give more pain aud bleeding on the day of treatment and more bleeding than normal menstruation two weeks later (Table II).
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CONTRACEPTION
PAIN
.c
----
PVS VA
3
Foroups = ?. 45, p < .01 2
Finteractio n = 2.97, p < . 0 5 i l h r , ~ t sign., p<.Ol and .05 I
I
I
t
2
3
Occasions
4
PVS
BLEEDING
~ - -
r-
ilg
~A
Foccasion s = 24.64, p < .000
&
Fgroup s = 83.00, p<.O00
2
~'~'~..L/I
Finteractio n = 3.90, p<..05 ~tr~r~¢,~¢~¢ t sign., p<.OOl and.O
1 I 1
| 2
I 3
Occasions
Fig. 3. Reported side-effects of pain and bleeding iu the prostaglaudiu (PVS) and vacuum aspiration (VA) groups. Interviewer rated patients" responses I = No pain (bleeding), 2 = A little, 3 = Moderate, 4 = Very much. Significant out-comes from three-way analysis of variance and t-test are given. The subjective reports indicated a significantly longer duration and amount of bleeding iu patients treated with prostaglaudiu (Fig. 3, Table II). Clinical observations confirmed longer duration for the uousurgical method. But Hb analyses made I and 2 weeks after treatment resulted in normal values for both groups. Table II. Patients" ratings of pain and bleeding on 5-point scales with 3 defined as own regular menstruation. Ratings
of BLEEDING
pAIN PVS
VA
t
PV8
VA
After treatmerit
M SD
4.07
2.63
4.41"**
3.77
1.97
1.12
1.43
1.15
.98
Two weeks later
M SD
3.77 1.38
3.07 1.50
3.90 1.19
3.10 1.54
1.88
t 6.52***
2.25*
***p~.O01, *p~.05
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FEBRUARY 1979 VOL. 19 NO. 2
CONTRACEPTION
Gastrointestinal side-effects from vaginal administration of prostaglaudiu have been reported but can be effectively mastered by medication (5,6). In the present study the patients both expected and experienced some disturbance on the day of treatment but ratings of Diarrhea and Nausea were low with means around 2 (A little). Ratings of Infection and Fever were higher pre- than posttreatment and significantly higher for the operative p r o c e d u r ~ After treatment the ratings'were low for both groups. Ratings of Tiredness followed the same trend iu both groups, and there were uo significant differences between the groups. The ratings peaked on the day of treatment, when the level of fatigue was rated as moderately high. The same doctors but different groups of personnel were responsible for the treatment and nursing of the prostaglandin and vact~m aspiration patients. They rated the personnel they had interacted with during treatment equally positively, however. The ratings were made on the set of semantic scales presented iu Figure 4. The means of each group were in the positive end of all scales and the profiles drawn were closely parallell. The means differed only on one scale.
The w a y t h e y t r e a t e d m e w a s B a d - Good Interested-Uninterested
PV5 Relaxed -Stressed
VA
$Tmpathettc - U n s y m ~ t h e f l ¢ Disagreeable
-
Agreeable
Cold - Warm
Pleasant-Unpleasant Unsnvolved -/nvolved Kind - Unkind 5Oft - Hard Authorltartan-Unauthorttarlan
t s i g n . p = .05 I
I
I
t
i
i
t
1
2
3
~
5
6
7
Ratings
Fig. 4. Profiles of ratings on semantic scales indicating how the prostaglaudiu (PVS) and vacuum aspiration (VA) patients perceived the clinical personnel engaged in treatment. DISCUSSION There is a present interest in developing uonsurgical methods for terminating pregnancy as a complement to other means. In judging the success of any method various aspects become important, e.g. efficiency, safety and cost. An equally important aspect is how
FEBRUARY
1979 VOL. 19 NO. 2
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CONTRACEPTION acceptable a method is to a user, potential or actual. The acceptability to the individual user may eventually become the crucial factor for success of a new method related to fertility regulation if it is implemented into a program in family planning. Some conclusions based on the findings of attitudinal changes in the present study may be useful iu assessing how acceptable to patients two new methods for therapeutic abortions are. Before the patients were randomly assigned to treatment they clearly distinguished between methods for inducing abortion and their potential side-effects and held different attitudes to them. Vacuum aspiration was less known than prostaglandin treatment and was e f f e c t i v e l y e v a l u a t e d in the indifference region on the semantic scales. One reason for this finding may be the reputation of the Department to use prostaglandin vaginal suppositories for termination of early pregnancy. The significant changes in ratings and preferences in the group treated by vacuum aspiration may be explained both by a better perception after treatment of the characteristics of the method and an appreciation of the quick and painless procedure. Two weeks after treatment most of the patients in this group preferred vacuum aspiration to other methods should they have another abortion at a clinic and 6 chose the pharmacological procedure. Further, 12 patients were positive to using a self-administered method outside a clini% if it were possible. This attitude had not changed from treatment. The conclusion is that vacuum aspiration as a method to induce abortion was highly acceptable to the group but that several a m ~ the patients also had a positive ~titude to a hypothetical, nonsurgical and self-administered method. The pharmacological procedure was highly acceptable to the patients given prostaglandin suppositories. The main finding for this method was the increased preference for it and the significant change into a still more positive attitude to self-administration outside a clinic. Despite the fact that this treatment was more negatively evaluated with regard to pain and duration of treatment, such characteristics were obviously outweighed by other, more important ones. Most frequent reasons for choices were related to the perceived naturalness of the method and the privacy during treatment and, potentially, also for the decision to abort. Patients treated at a modern clinic and relieved from a health problem, e.g. by a therapeutic abortion, will probably in general evaluate treatment positively. The attitude of patients to use a new method provides complementary and useful information in research on methods in family planning. From this point of view the most important finding from the present study was the evidence for an intention to use a pharmacological method in self-administration. This attitude was sufficiently strong to be a great encouragement to further research on vaginally administered prostaglandin as an abortifacient.
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ACKNOWLEDGEMENTS The study was supported by a grant (H9/181/255) from WHO Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Acceptability Research in Family Planning, World Health Organization, Geneva. REFERENCES I.
LundstrSm, V., Bygdemau, M., Fotiou, S., Gr@en, K. and Kinoshita, K. Abortion in early pregnancy by vaginal administration of 16,16-dimethyl PCE~ in comparison with vacuum aspiration. Prostaglandius, 1977, 16, 167-173.
2.
Marshall, J.F. Acceptability of fertility regulating methods: Designing technology to fit people. Preventive Medicine, 1977, 6, 65-75.
.
.
0sgood, C.E., May, W.H. and Miron, M.S. Cross-cultural Universals of Effective Meaning. Urbana: Univ. of Illinois Press, 1975. Guilford, J.P. Psychometric Methods. New York: Wiley,
1954. .
6.
Bygdeman, M., Martin, Jr., J.N., Leader, A., LundstrSm, V., Ramadan, M., Eneroth. P., and Gr4en, K. Early pregnancy interruption by 15(S115 methyl prostaglaudin F2~methyl ester. 0bstet Gyuecol, 1976, 48, 221-224. Bygdemau, M., Borell, U., Leader, A., LundstrSm, V., Martin, Jr., J.N., Eueroth, P., and Green, K., in Advances in Prostaglandiu and Thromboxane Research (B. Samuelsson and R. Paoletti, Editors). Raven Press, New York, 1976, vol. 2, p. 693-704.
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117
ACCEPTABILITY OF A NONSURGICAL METHOD TO TERMINATE VERY EARLY PREGNANCY IN COMPARISON TO VACUUM ASPIRATION Anne-Sofie Ros~n I , Lars Nystedt I, Marc Bygdemau 2 and Viveca Lundstr8m 2 IDepartment of Psychology, University of Stockholm, 2Department of Obstetrics and Gynecology, Karolinska Hospital, Stockholm, Sweden.
ABSTRACT Seventy-seven patients applying for abortion during early pregnancy consented to be treated by prostaglandin vaginal suppositories or vacuum aspiration by Kahrman catheter in a random design. They also consented to participate in an acceptability study of the two procedures. Attitude and preference measures were obtained by interviewing and rating scales on three occasions: before assignment to abortion procedure, immediately after treatment, and two weeks later. The first 50 patients with complete abortion by either procedure participated in the acceptability study. Both treatments were positively evaluated but perceived to have very different characteristics. The preference for the method used for own treatment increased iu both groups. Before treatment 1/3 of the patients in each group had a positive attitude to a selfadministered method to induce abortion outside clinics. This proportion increased significantly after treatment but only in the group that received prostaglandin by the vaginal route.
Accepted
for p u b l i c a t i o n
January
FEBRUARY 1979 VOL. 19 NO. 2
3, 1979
107
CONTRACEPTION
INTRODUCTION An increasing number of the therapeutic abortions are performed during early pregnancy. The methods mainly used at present are vacuum aspiration with Kahrmau catheter during the first weeks following the first missed menstrual period and with metal catheter during the later part of the first trimester. These procedures are very satisfactory in many respects but a nousurgical method could be an attractive alternative in some situations. A pharmacological method offers the obvious advantage of selfadministration on a day off at home and avoids the publicity in an abortion clinic. Some women may also prefer a treatment resulting in a menstrual-like bleeding instead of au operative procedure. The administration of prostaglaudin analogues seems to be useful for this purpose. Recently the results were published from a study of a randomized comparison between repeated vaginal administration of 16,16dimethyl-PGE9 and vacuum aspiration for termination of early pregnancy in'women with up to 56 days of amenorrhea (I). It was concluded in this report that both methods were equally effective but that vacuum aspiration was superior with regard to time, duration of bleeding and frequency of gastrointestinal side effects. An advantage of the vaginal treatment was its simplicity of administration and the possibility of self-administration. Such features of the uonsurgical method may for some women have outweighed the disadvantages noted in the comparison with the operative procedure. The present study was undertaken to explore the acceptability of the new uousurgical method iu comparison with vacuum aspiration to patients admitted to the hospital for termination of au early pregnancy. Acceptability refers to how the attributes of a method are evaluated by a person (2). The degree of acceptability can be assumed to influence his or her willingness or intention to use it. METHODS Patients Altogether 77 women in the 5th to 8th week of pregnancy (up to 56 days of amenorrhea) consented to be treated with prostaglandiu vaginal suppositories or vacuum aspiration in a randomized design. The patients had been admitted to the clinic by the regular procedure for abortion applicants. They were asked to participate in an acceptability study for evaluating treatment and only one patient refused. The patients were similar in background variables to others who apply for a termination of an early pregnancy at the hospital. Thirty-six women had one to three children (M=1.7). Six
108
FEBRUARY
1979 VOL. 19 NO. 2
CONTRACEPTION
women were housewives, one was unemployed, 40 worked outside home and 13 studied. Nineteen women had had one or more therapeutic abortions earlier. The previous education varied among the patients, from 9 years compulsQry school to university degree. The data from the first 30 patients with complete abortion by either of the two methods were used for the acceptability study. Procedure for abortion treatment S e r u m HCG (human chorionic gonadotrophin) had been measured to ensure pregnancy in all cases before treatment. The efficacy of the treatment was judged by weekly measurements of haemoglobin (Hb) and HCG and by gynecological examination performed after two weeks or when clinically indicated. Prosta~landin treatment. Vaginal suppositories containing 16,16dimethyl PGE^ were given on four occasions at 3-hour intervals. The first tw~ suppositories contained 0.8 mg and were followed by two doses of I mg. The first three suppositories were inserted in the ward. The forth suppository was generally administered by the woman herself in the afternoon after returning home. The patients stayed in bed for one hour after the insertion but were permitted to ambulate freely for the two following hours. The patients were nursed and supervised by the nurses engaged by the WHO Clinical Research Unit at the Karolinska Hospital. Vacuum aspiration. Vacuum aspiration was performed with a Kahrman catheter, size 5 or 6, following an intravenous injection of diazepam and paracervical block with 20 ml 0.5 mg/ml prilocaiu chloride. Normally the patient stayed in the hospital for four hours. The operation was performed by one of two surgeons and the patients nursed by the regular operation ward staff at the Department of Obstetrics and Gynecology at the Karoliuska Hospital. Procedure for acceptability study: Observations were obtained for each patient on three occasions: I) immediately prior to t h e ~ r s t appointment with the gynecologist, who later assigned the patient to a treatment when pregnancy had been confirmed; 2) on the day of abortion before the patient went home after treatment; and 3) two weeks after treatment when the patient came back for the gynecological examination. Table I presents the plan for collecting observations by use of interview schedules and various rating scales. A female trained psychologist with considerable experience from clinical ana nonclinical interviewing was engaged for the data collection.
FEBRUARY
1979 VOL. 19 NO. 2
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CONTRACEPTION
Table I. Schedule for the acceptability study. An X marks when an observation was made. The occasions were: I. before assignment to treatment; 2. after treatment, before going home; 3. two weeks after treatment. Observations
Occasions I 2 3
Knowledge of methods of abortion Preference of methods Reasons for preferences Attitude to self-administration Side-effects: expected ,' experienced Semantic ratings: of different methods of own treatment of personnel
X X X X X
X X X X
X
X
X X
X
On occasion I the interviewer asked the patient to report in her own words what she knew about clinical methods for inducing abortion. Ten questions were asked for each method named or described and the responses later used to assess knowledge of methods. The interviewer presented a typed, noutechnical description of abortion by prostaglandin suppositories, vacuum aspiration and dilation with curettage and read it aloud to the patient. Her preferences among the three methods, pairwise presented, were recorded and again on occasion 3. Her reasons for a preference were also recorded. The attitude towards performing a self-administered abortion by a pharmacological method with or without a previous contact with a clinic was assessed from interview questicus on occasion I and 3. The interview schedule contained questions about seven side-effects from the abortion methods: Pain, Bleeding, Infection, Fever, Tiredness, Nausea, and Diarrhea. The interviewer categorized the responses to questions about expected and experienced side-effects as Not at all, A little, Moderate, Very much. The patient rated amount of pain and bleeding from treatment as compared to normal menstruatiou. A five-point scale was used with a midpoint defined as 'the same as my usual menstrual pain' (or bleeding). Semantic ratings of abortion methods were made by the patient on 12 bipolar adjective scales with 7 points, e.g. the scale Good Bad. The general procedure for the semantic differential technique was followed (3). A set of semantic rating scales was also used by the patient to evaluate the personnel and the way she had been treated by them.
110
FEBRUARY
1979 VOL. 19 NO. 2
CONTRACEPTION
RESULTS Clinical findings Vacuum aspiration and vaginal administration of 16,16-dimethyl PGE 2 were equally effective in the group of 77 patients. All patients with the exception of one woman in the surgically treated group aborted as result of the treatment. Abortion was complete in 95 per cent of cases for vacuum aspiration and 93 per cent for vaginal administration of prostaglandin. Bleeding generally started 2 to 8 hours from the start of the prcstaglandin treatment and continued for 10 to 14 days in most patients. The duration of bleeding was slightly shorter following the operative procedure. The means of the groups were 9.3 and 11.9 days. Occasional episodes of vomiting and/or diarrhea occurred in 9 of the prostaglandin treated patients. Injections of either peutazocine or mepiridine hydrochloride were given to 9 patients during prostaglandin treatment. Acceptability study No difference between the groups could be detected in background variables as age, number of childbirths and abortions, in educational and professional level. Nor were there any differences in their knowledge of how abortion is performed. In both groups vacuum aspiration was the least known procedure. Totally, 53 patients mentioned and/or described dilation with curettage, prostaglandin was mentioned 39 times, saline injection 26 and vacuum aspiration 24 times. The patients" preferences for methods before and after treatment were obtained from paired comparisons and scales (4). The scale values for three abortion methods were linearly transformed and referred to a common, arbitrary origin, defined as the value of the least preferred method in one group. Figure I illustrates the position of the three methods on a subjective continuum of preference, Rj, for the two groups. Two facts are evident from Figure I. Firstly, prostaglandin treatment was the most preferred method before abortion in both groups followed by vacuum aspiration and dilation with curettage. The preference was slightly more pronounced in the prostaglaudin group Secondly, after abortion this group was even more favorable to prostaglandin treatment than to the other methods. The other group changed their preference order and after abortion preferred vacuum aspiration over the other methods.
FEBRUARY
1979 VOL. 19 NO.2
111
CONTRACEPTION
Group PVS
( ~ =PVS (~=VA (~) = Cur
J
-o.
,Io
2'o
. Rj
Scale values by paired comparisons abortion
Group VA
D
Ri
After abortion
Fig. I. Subjective scales for three abortion methods in the two groups of patients. PVS denotes prostaglaudin suppositories, VA vacuum aspiration and Cur dilation with curettage. Positions of the methods before and after abortion on subjective continua of preference are indicated. Origin is arbitrary. The attitude to self-administered abortion without or with contact with physician or clinic chauged significantly in the prostaglandin group. Before treatment 10 women in each group affirmed that they would, without contacting a physician first, try a self-administered procedure at home if something like the prostaglandin suppositories was available. This figure increased to 17 in the prostaglandin group after abortion ( ~ for change = 4.00, df = I, P ~ 0 . 5 ) . In the other group there was no change in this attitude ( ~ for change = 0.33, df = I). The patients in the latter group who before treatment were favorable to a self-administrative procedure remained so. The pre- and posttreatmeut ratings of own treatment ou the semau±ic scales were analyzed by analysis of variance for repeated measures, separately for each scale, in order to explore how the abortion procedure was perceived by each group and how the evalus~ tions may have changed from treatment. Between group comparisons revealed that the ratings were significantly higher over the three occasions for the scales Easy and Fast in the group treated by the operative procedure and for Painful and Active in the prostaglandin group (Fig. 2). The prostaglandin vaginal administration had been positively evaluated by the patiauts before they had been assigned to be treated by this procedure. The mean ratings were above 5 on 7-point s c a l e ~ e.g. for Bad vs. Good, and Negative vs. Positive. The positive evaluations did not change from treatment experiences in this group. The only change noted was that posttreatmeut the patients rated the procedure as significantly more Calm aud Warm (Fig. 2). Before treatment the other group had rated vacuum aspiration in
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the midregion of each bipolar scale with the exception of a high rating for Fast. Posttreatment the ratings of vacuum aspiration had changed significantly in the positive direction on all scales except those referring to the swiftness of the procedure aud the level of activity and pain involved. These patients still perceived the procedure as very quick but rather passive and painless.
Dreadful- Calm P a i n f u l - Painles~
B a d - Good
i
Unpleasant - Plea:ant Negative - Positive F r i g h t e n i n g - Harmle:~s Unattractive
- Attractive
Cold - W a r m D i s a g r e e a b l e - Agreeable PaJslve - Active
Hard - Easy S I ow - Fa$ t Significant •
difference
Nonsignificant I
-3
I
-2
difference
i
i
i
i
i
-1
O
1
2
3
Difference scores
Fig. 2. Difference scores in ratings on semantic scales pre- and posttreatment. Each point of a profile indicates the mean difference on the scale in the prostaglaudin (PVS) and vacuum aspiration (VA) groups. Significant differences are indicated. All scales have the positive poles to the right. The interviewer scored the patieuts" responses to questions conceruing each side-effect as Not at all (=I) to Very much (=4). A three-way analysis of variance for repeated measures was performed of these ratiugs, one for ~a~h s ~ e - e f f e c t , aud some results are preseuted in Figure 3. The prostaglaudiu group had expected and experienced mere pain from treatment ~nan the vacuum aspiration group. In the two weeks following treatment there was no difference between the groups (Fig. 3). The groups differed significantly iu their reports of bleediug, subjectively reported to be much larger from prostaglaudin treatment. The interviewer's scoriug of the patients" responses to interview questious were consisteut with the p~tients" ewu ratings on five-point scales of pain and bleediug as compared to owu regular menstruation. Prostaglaudiu treatmeut was rated to give more pain aud bleeding on the day of treatment and more bleeding than normal menstruation two weeks later (Table II).
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PAIN
.c
----
PVS VA
3
Foroups = ?. 45, p < .01 2
Finteractio n = 2.97, p < . 0 5 i l h r , ~ t sign., p<.Ol and .05 I
I
I
t
2
3
Occasions
4
PVS
BLEEDING
~ - -
r-
ilg
~A
Foccasion s = 24.64, p < .000
&
Fgroup s = 83.00, p<.O00
2
~'~'~..L/I
Finteractio n = 3.90, p<..05 ~tr~r~¢,~¢~¢ t sign., p<.OOl and.O
1 I 1
| 2
I 3
Occasions
Fig. 3. Reported side-effects of pain and bleeding iu the prostaglaudiu (PVS) and vacuum aspiration (VA) groups. Interviewer rated patients" responses I = No pain (bleeding), 2 = A little, 3 = Moderate, 4 = Very much. Significant out-comes from three-way analysis of variance and t-test are given. The subjective reports indicated a significantly longer duration and amount of bleeding iu patients treated with prostaglaudiu (Fig. 3, Table II). Clinical observations confirmed longer duration for the uousurgical method. But Hb analyses made I and 2 weeks after treatment resulted in normal values for both groups. Table II. Patients" ratings of pain and bleeding on 5-point scales with 3 defined as own regular menstruation. Ratings
of BLEEDING
pAIN PVS
VA
t
PV8
VA
After treatmerit
M SD
4.07
2.63
4.41"**
3.77
1.97
1.12
1.43
1.15
.98
Two weeks later
M SD
3.77 1.38
3.07 1.50
3.90 1.19
3.10 1.54
1.88
t 6.52***
2.25*
***p~.O01, *p~.05
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Gastrointestinal side-effects from vaginal administration of prostaglaudiu have been reported but can be effectively mastered by medication (5,6). In the present study the patients both expected and experienced some disturbance on the day of treatment but ratings of Diarrhea and Nausea were low with means around 2 (A little). Ratings of Infection and Fever were higher pre- than posttreatment and significantly higher for the operative p r o c e d u r ~ After treatment the ratings'were low for both groups. Ratings of Tiredness followed the same trend iu both groups, and there were uo significant differences between the groups. The ratings peaked on the day of treatment, when the level of fatigue was rated as moderately high. The same doctors but different groups of personnel were responsible for the treatment and nursing of the prostaglandin and vact~m aspiration patients. They rated the personnel they had interacted with during treatment equally positively, however. The ratings were made on the set of semantic scales presented iu Figure 4. The means of each group were in the positive end of all scales and the profiles drawn were closely parallell. The means differed only on one scale.
The w a y t h e y t r e a t e d m e w a s B a d - Good Interested-Uninterested
PV5 Relaxed -Stressed
VA
$Tmpathettc - U n s y m ~ t h e f l ¢ Disagreeable
-
Agreeable
Cold - Warm
Pleasant-Unpleasant Unsnvolved -/nvolved Kind - Unkind 5Oft - Hard Authorltartan-Unauthorttarlan
t s i g n . p = .05 I
I
I
t
i
i
t
1
2
3
~
5
6
7
Ratings
Fig. 4. Profiles of ratings on semantic scales indicating how the prostaglaudiu (PVS) and vacuum aspiration (VA) patients perceived the clinical personnel engaged in treatment. DISCUSSION There is a present interest in developing uonsurgical methods for terminating pregnancy as a complement to other means. In judging the success of any method various aspects become important, e.g. efficiency, safety and cost. An equally important aspect is how
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CONTRACEPTION acceptable a method is to a user, potential or actual. The acceptability to the individual user may eventually become the crucial factor for success of a new method related to fertility regulation if it is implemented into a program in family planning. Some conclusions based on the findings of attitudinal changes in the present study may be useful iu assessing how acceptable to patients two new methods for therapeutic abortions are. Before the patients were randomly assigned to treatment they clearly distinguished between methods for inducing abortion and their potential side-effects and held different attitudes to them. Vacuum aspiration was less known than prostaglandin treatment and was e f f e c t i v e l y e v a l u a t e d in the indifference region on the semantic scales. One reason for this finding may be the reputation of the Department to use prostaglandin vaginal suppositories for termination of early pregnancy. The significant changes in ratings and preferences in the group treated by vacuum aspiration may be explained both by a better perception after treatment of the characteristics of the method and an appreciation of the quick and painless procedure. Two weeks after treatment most of the patients in this group preferred vacuum aspiration to other methods should they have another abortion at a clinic and 6 chose the pharmacological procedure. Further, 12 patients were positive to using a self-administered method outside a clini% if it were possible. This attitude had not changed from treatment. The conclusion is that vacuum aspiration as a method to induce abortion was highly acceptable to the group but that several a m ~ the patients also had a positive ~titude to a hypothetical, nonsurgical and self-administered method. The pharmacological procedure was highly acceptable to the patients given prostaglandin suppositories. The main finding for this method was the increased preference for it and the significant change into a still more positive attitude to self-administration outside a clinic. Despite the fact that this treatment was more negatively evaluated with regard to pain and duration of treatment, such characteristics were obviously outweighed by other, more important ones. Most frequent reasons for choices were related to the perceived naturalness of the method and the privacy during treatment and, potentially, also for the decision to abort. Patients treated at a modern clinic and relieved from a health problem, e.g. by a therapeutic abortion, will probably in general evaluate treatment positively. The attitude of patients to use a new method provides complementary and useful information in research on methods in family planning. From this point of view the most important finding from the present study was the evidence for an intention to use a pharmacological method in self-administration. This attitude was sufficiently strong to be a great encouragement to further research on vaginally administered prostaglandin as an abortifacient.
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ACKNOWLEDGEMENTS The study was supported by a grant (H9/181/255) from WHO Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Acceptability Research in Family Planning, World Health Organization, Geneva. REFERENCES I.
LundstrSm, V., Bygdemau, M., Fotiou, S., Gr@en, K. and Kinoshita, K. Abortion in early pregnancy by vaginal administration of 16,16-dimethyl PCE~ in comparison with vacuum aspiration. Prostaglandius, 1977, 16, 167-173.
2.
Marshall, J.F. Acceptability of fertility regulating methods: Designing technology to fit people. Preventive Medicine, 1977, 6, 65-75.
.
.
0sgood, C.E., May, W.H. and Miron, M.S. Cross-cultural Universals of Effective Meaning. Urbana: Univ. of Illinois Press, 1975. Guilford, J.P. Psychometric Methods. New York: Wiley,
1954. .
6.
Bygdeman, M., Martin, Jr., J.N., Leader, A., LundstrSm, V., Ramadan, M., Eneroth. P., and Gr4en, K. Early pregnancy interruption by 15(S115 methyl prostaglaudin F2~methyl ester. 0bstet Gyuecol, 1976, 48, 221-224. Bygdemau, M., Borell, U., Leader, A., LundstrSm, V., Martin, Jr., J.N., Eueroth, P., and Green, K., in Advances in Prostaglandiu and Thromboxane Research (B. Samuelsson and R. Paoletti, Editors). Raven Press, New York, 1976, vol. 2, p. 693-704.
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