Contraception
45:547-559,
1992
CONDITIONS FOR CHOOSING BETWEEN DRUG-INDUCED AND SURGICAL ABORTIONS A. Bachelot, LCludy, A. Spira I.N.S.E.R.M. Unit 292 H&pita1 de Bicetre, 78, rue du G6neral Leclerc 94275 Le Kremlin Bidtre Cedex France
ABSTRACT
In France, pregnant women with amenorrhoea of no more than 49 days intending to terminate pregnancy can choose between a surgical abortion via vacuum aspiration under local or general anesthesia and a drug method combining Mifepristone orally administered (RU 486”), with a prostaglandin analogue. This prospective survey was conducted to study the conditions under which women choose their abortion method, and to evaluate the acceptability of each method after the abortion. The data gathered from 488 women were analyzed according to their initial decision, and then according to the method actually used. The majority (62%) chose RU 486. The women’s choice was found to be linked to so&demographic characteristics such as age, education, occupation, geographic origin, and certain attitudes towards pregnancy, as well as to the individual criteria of each method. The women who chose the drug protocol had most often already made their decision before going to the family planning center (68%), having been advised by their doctor (20%). They were slightly less satisfied with the abortion experience than they had expected: 12.4% were unsatisfied in the RU group and 3.6% in the aspiration group. They needed more rest and quiet
afterwards (50%) than the other women. They were distinguished by their desire to verify the expulsion (63%). The length of pregnancy is therefore not the only criterion to be considered when recommending one or other of these methods: the women concerned have different requirements and should have several possibilitiesto choose from.
lNTRODUCllON Since MifepristoneO was first sold in France, in 1990, family planning centers have been able to offer two different methods to women wishing to terminate a pregnancy the surgical method of vacuum aspiration under local or general anesthesia and the drug method of Mifepristone followed by a prostaglandin analogue. French law on legally induced abortion authorizes surgical abortions up to 12 weeks of amenorrhoea, and drug-induced abortions are governed by the same law. The drug method is authorized for amenorrhoea of less than 50 days, i.e., only when early pregnancy is diagnosed, and its prescription is strictly regulated (1,2). A large number of studies have been published on the conditions under which women opt to have an abortion. Friedman et al. (3), Handy (4), and Gisselmann & Viret (5) have studied women’s attitudes toward abortion, while Payne et al. (6) and RomansClarkson (7) examined the psychologicalconsequences of interrupting a pregnancy. o RU 486
(Mifepristone),
Laboratoire
Submitted for publication Accepted for publication
Roussel.
February 17, 1992 April 14, 1992
Copyright 0 1992 Butterworth-Heinemann
Contraception
548
Urquhart 81 Templeton (8) and Hill et a/. (9) have analyzed the efficacy and acceptability of RU 486. Research comparing the surgical and drug methods is only just starting, even if as early as 1979, Rosen et a/. (10) used a randomized study to show that the prostaglandin drug method was an acceptable means of abortion . Recently, Cameron 81 Baird (11) worked on four groups of subjects to compare the efficacy and scale of side effects related to vacuum aspiration and drug-induced abortion, with prostaglandin on its own, RU 486 on its own or a combination of the two. Again, the authors concluded that tolerance to the RU 486 drug method was high, and that side effects were linked to the combination of RU 486 and prostaglandin, which is still the most efficient method. In France the number of patients coming to family planning centers early enough to be able to choose between these two options is still low, but it could increase when the general public learns more about the conditions for using RU 486. The decision process was studied at two levels. We first analyzed the main characteristics linked to the women’s choice, and the criteria that lead them to prefer either a drug method using RU 486 or a traditional surgical method. The second step was to assess the acceptability of each method by verifying whether or not the women were pleased with the choice they made after the abortion, depending on their expectations and their experiences during the abortion process. METHODS Three groups were created
based on the three protocols available to the women: RU
486, ie. Mifepristone (600 mg) followed by Sulprostone” (0.25 mg administered by intramuscular injection 48 hours later), vacuum aspiration under local anesthesia, and vacuum aspiration under general anesthesia. The “ASPI-LA” group for vacuum aspiration under local anesthesia and the “ASPI-GA” group for general anesthesia were compared to the “RU” group of women who chose the drug method. A detailed information sheet, approved by all the participating medical staff, was presented to the women when they arrived at the family planning center. Data was collected prospectively in two stages via two pretested, self-administered questionnaires. Before the abortion, the women filled out one questionnaire when they arrived, after reading the information sheet on the various methods available and before any interview with medical personnel. Questions involved sociodemographic characteristics, gyneco-obstetrical history, attitude toward the pregnancy, reasons for interrupting the pregnancy, the selection criteria for each method, and the intended choice of each person surveyed. The choice had to be indicated before the decision could possibly be influenced by the center’s medical staff. To study the selection criteria, the questionnaire included three series of opposing opinions regarding drug-induced abortion, surgical abortion, and contrasting the two methods. The woman was supposed to choose one of the two opinions offered for each. Around 2 weeks after the abortion, the women filled out a second questionnaire before the follow-up visit. The questions concerned the various moments and people that played a role in the decision-making process, the channels of information, experience during the method, and the possibility of another abortion. The data was supplemented by two forms filled out by center personnel, summarizing the information obtained during the pre-abortion visit (medical history, possible contra-indication, actual decision) and the post-abortion follow-up visit (protocol used, prescription of analgesics, side effects, outcome of the abortion).
O0
Nalador, Laboratoire
Schering.
Contraception
549
This multicenter survey was performed in association with six authorized public and private family planning centers*. The survey was conducted over a period of eight months (February 15, 1990 to October 15, 1990). Only 7 people refused to participate. A total of 555 subjects were included, depending on the number of places available in the centers, the criteria for duration of amenorrhoea (42 days at the most to qualify for the legal period in France), and level of literacy (ability to read and write in French). Of this total, 4 women were later excluded following a medical examination which revealed amenorrhea of more than 49 days. Of the remaining 551 subjects, 63 women (1 1%) were lost to followup after their interview with center medical personnel. They may have decided not to terminate their pregnancy or preferred to terminate it elsewhere. This group did not exhibit different characteristics from the rest of the sample concerning age, geographic origin, education, occupation, and had the same distribution pattern in choice of method as the other groups. This group was analyzed separately. Only 396 of the second questionnaires were collected, i.e., 81% of the expected total of 488 (with 64% having had a drug-induced abortion, 27% vacuum aspiration under local anesthesia, and 9% vacuum aspiration under general anesthesia). However, medical forms were collected for all the abortions that were actually performed. Data from the first questionnaire, on the women’s characteristics and selection criteria, were analyzed according to the intended choice entered at the end of the questionnaire. The group of women who expressed “no preference” (NO CHOICE) was kept in the analysis. They were less numerous but sometimes had different characteristics from the other groups. To verify that major differences between groups were not due to the presence of these women, the data were analyzed again without them when necessary. The acceptability of each method (2nd questionnaire) was studied according to the abortion technique used. All of the results were adjusted on the survey site. The statistical tests used were the Chi-square test and the adapted Mantel-Haenszel Chi-square test for comparing percentages (12), and analysis of variance for comparing means. Logistic regression was used for taking into account the influence of the choice criteria. Adjusted odd ratios were calculated as well as 95% confidence intervals. Data were analyzed with SAS software, on VAX 8530 at the INSERM computer centre in Villejuif (France).
*
List of participating centers: Centre d’orthogenie de la Maternite des Lilas (93 Les Lilas), private family
planning center at the Lilas Maternity Hospital Centre d’orthogenie de I’Hopital de Bi&tre (94 le Kremlin Bicetre), public family planning center at the Bicetre Hospital Service de Gyneco-Obstetrique de I’Hbpital de Villeneuve-Saint-Georges (94 Villeneuve-Saint-Georges), public gynecology-obstetrics department at the Villeneuve-Saint-Georges Hospital Centre de Planification de I’Hopital Saint-Jacques (44 Nantes), public family planning center at the Saint-Jacques Hospital Centre d’orthogenie de I’Hopital de la Fraternite (59 Roubaix), public family planning center at the Fraternite Hospital Centre d’orthogenie de I’Hopital J. Ducuing (3 1 Toulouse), private family planning center at the J. Ducuing Hospital.
Contraception
RESULTS
Of the 488 women surveyed in this study, the majority (62%) chose RU 486. Sociodemographic characteristics The four groups of women under consideration (RU, ASPI-LA, ASPI-GA and NO CHOICE) show significant differences in age, education, occupation and geographic origin. Women in the RU and ASPI-GA groups were younger (Table I). A majority of women in the RU (59%) and ASPI-GA (64%) groups were between 14 and 29 years of age. Women in the ASPI-LA group (59%) were older, i.e., 30 years of age or more. This result remains significant if the NO CHOICEgroup is excluded (~~0.01).
TABLEI : INTENDEDCHOICESOF THE WOMENBYAGE GROUP AGEGROUP
NO CHOICERU486 (%)
(%)
AS&LA
ASPI-GA
(%)
(%)
14 - 29 years old
2 30 years old
2446.7)
(2::)
(4&
(6?9)
16 (53.3)
123 (41.3)
(SZ)
(3zs.61) p < 0.05
TOTAL
268 (55.7) 213 (44.3) p < 0.05*
* after adjusting for abortion center. The RU and ASPI-LA groups had higher levels of education (Table II). Of the women who were no longer students, 41% of the RU group and 40% of the ASPI-LA group had had some form of higher education. In the ASPI-GA group, 54% of the women had attended a primary or technical school, and 60% of the NO CHOICEgroup had attended a secondary school (pdO.01). This difference remains significant if the NO CHOICE group is excluded. It is also significant if this comparison is adjusted for age (~~0.05).
Women in the RU group were in a higher occupational class (Table II). They were often “managers or senior personnel” (34%) or “students or seeking employment” (25%). Women in the ASPI-LA group were also “managers or senior personnel” (33%), but differed from the RU group in the number of “ordinary employees or blue collars” (27%). Women in the ASPI-GA group tended to be “ordinaly employees or blue collars” (35%), or “students or seeking employment” (34%). Many of the women in the NO CHOICEgroup were “ordinary employees or blue collars” (36%)(Table II).
551
Contraception TABLE
II: INTENDED CHOlCES OF THE WOMEN BY LEVEL OF EWCATlON AND OCCUPATlON
LEVEL OF EDUCATlON
primary and technical
NO CHOICE w
(2040)
Ru486
ASPI-LA
ASPI-GA
w
w
w
(3::)
(3:;)
(523:)
134 (36.3)
(2::)
(2::)
101 (27.4)
10 (19.2) p < 0.01
secondary (6::) higher
TOTAL
(2040)
95 (40.6)
(3;;)
NO CHOICE
Ru486
ASPI-LA
ASPI-GA
(96)
w
w
(1640)
(lF3)
(2&
(l&)
(1Z)
(20?0)
(2L43)
(l&
(3::)
113 (24.2)
agricultural, small business, shopkeepers
2 (8.0)
(s!s’)
managers or senior personnel
(2czO)
100 (34.1)
(3::)
(I&
141 (30.1)
ordinary employees or blue collars
(369.0)
(2596)
(226.‘6)
(3::)
124 (26.5)
OCCUPATIONAL CLASS
w
134 (36.3) p < 0.01* TOTAL
housewives
students or seeking employment**
(766)
(1.14)
p < 0.01
(5266)
p < o.os*
l
after adjustingfor abortioncenter. ** giventhe low numberof subjects,this groupincludeswomenwho have not yet obtaineda definite occupationor an independentincome.
This difference in distribution appears again if the two largest occupational classes are the only ones considered, i.e., “managers or senior personnel” and “ordinary employees or blue collars”, and the NO CHOICEgroup is excluded (~~0.01). Women in the ASPI-GA group were more often ordinary employees or blue collars (71%). In the RU group (59%) and the ASPI-LA group (55%), they were more often managers or senior personnel. When age is taken into account, the difference in occupational class is only found in women aged 30 or older; most of the younger women were ordinary employees or blue collars, whatever their choice. Age and occupational class were found to be closely related (p
45:547-559,
1992
CONDITIONS FOR CHOOSING BETWEEN DRUG-INDUCED AND SURGICAL ABORTIONS A. Bachelot, LCludy, A. Spira I.N.S.E.R.M. Unit 292 H&pita1 de Bicetre, 78, rue du G6neral Leclerc 94275 Le Kremlin Bidtre Cedex France
ABSTRACT
In France, pregnant women with amenorrhoea of no more than 49 days intending to terminate pregnancy can choose between a surgical abortion via vacuum aspiration under local or general anesthesia and a drug method combining Mifepristone orally administered (RU 486”), with a prostaglandin analogue. This prospective survey was conducted to study the conditions under which women choose their abortion method, and to evaluate the acceptability of each method after the abortion. The data gathered from 488 women were analyzed according to their initial decision, and then according to the method actually used. The majority (62%) chose RU 486. The women’s choice was found to be linked to so&demographic characteristics such as age, education, occupation, geographic origin, and certain attitudes towards pregnancy, as well as to the individual criteria of each method. The women who chose the drug protocol had most often already made their decision before going to the family planning center (68%), having been advised by their doctor (20%). They were slightly less satisfied with the abortion experience than they had expected: 12.4% were unsatisfied in the RU group and 3.6% in the aspiration group. They needed more rest and quiet
afterwards (50%) than the other women. They were distinguished by their desire to verify the expulsion (63%). The length of pregnancy is therefore not the only criterion to be considered when recommending one or other of these methods: the women concerned have different requirements and should have several possibilitiesto choose from.
lNTRODUCllON Since MifepristoneO was first sold in France, in 1990, family planning centers have been able to offer two different methods to women wishing to terminate a pregnancy the surgical method of vacuum aspiration under local or general anesthesia and the drug method of Mifepristone followed by a prostaglandin analogue. French law on legally induced abortion authorizes surgical abortions up to 12 weeks of amenorrhoea, and drug-induced abortions are governed by the same law. The drug method is authorized for amenorrhoea of less than 50 days, i.e., only when early pregnancy is diagnosed, and its prescription is strictly regulated (1,2). A large number of studies have been published on the conditions under which women opt to have an abortion. Friedman et al. (3), Handy (4), and Gisselmann & Viret (5) have studied women’s attitudes toward abortion, while Payne et al. (6) and RomansClarkson (7) examined the psychologicalconsequences of interrupting a pregnancy. o RU 486
(Mifepristone),
Laboratoire
Submitted for publication Accepted for publication
Roussel.
February 17, 1992 April 14, 1992
Copyright 0 1992 Butterworth-Heinemann
Contraception
548
Urquhart 81 Templeton (8) and Hill et a/. (9) have analyzed the efficacy and acceptability of RU 486. Research comparing the surgical and drug methods is only just starting, even if as early as 1979, Rosen et a/. (10) used a randomized study to show that the prostaglandin drug method was an acceptable means of abortion . Recently, Cameron 81 Baird (11) worked on four groups of subjects to compare the efficacy and scale of side effects related to vacuum aspiration and drug-induced abortion, with prostaglandin on its own, RU 486 on its own or a combination of the two. Again, the authors concluded that tolerance to the RU 486 drug method was high, and that side effects were linked to the combination of RU 486 and prostaglandin, which is still the most efficient method. In France the number of patients coming to family planning centers early enough to be able to choose between these two options is still low, but it could increase when the general public learns more about the conditions for using RU 486. The decision process was studied at two levels. We first analyzed the main characteristics linked to the women’s choice, and the criteria that lead them to prefer either a drug method using RU 486 or a traditional surgical method. The second step was to assess the acceptability of each method by verifying whether or not the women were pleased with the choice they made after the abortion, depending on their expectations and their experiences during the abortion process. METHODS Three groups were created
based on the three protocols available to the women: RU
486, ie. Mifepristone (600 mg) followed by Sulprostone” (0.25 mg administered by intramuscular injection 48 hours later), vacuum aspiration under local anesthesia, and vacuum aspiration under general anesthesia. The “ASPI-LA” group for vacuum aspiration under local anesthesia and the “ASPI-GA” group for general anesthesia were compared to the “RU” group of women who chose the drug method. A detailed information sheet, approved by all the participating medical staff, was presented to the women when they arrived at the family planning center. Data was collected prospectively in two stages via two pretested, self-administered questionnaires. Before the abortion, the women filled out one questionnaire when they arrived, after reading the information sheet on the various methods available and before any interview with medical personnel. Questions involved sociodemographic characteristics, gyneco-obstetrical history, attitude toward the pregnancy, reasons for interrupting the pregnancy, the selection criteria for each method, and the intended choice of each person surveyed. The choice had to be indicated before the decision could possibly be influenced by the center’s medical staff. To study the selection criteria, the questionnaire included three series of opposing opinions regarding drug-induced abortion, surgical abortion, and contrasting the two methods. The woman was supposed to choose one of the two opinions offered for each. Around 2 weeks after the abortion, the women filled out a second questionnaire before the follow-up visit. The questions concerned the various moments and people that played a role in the decision-making process, the channels of information, experience during the method, and the possibility of another abortion. The data was supplemented by two forms filled out by center personnel, summarizing the information obtained during the pre-abortion visit (medical history, possible contra-indication, actual decision) and the post-abortion follow-up visit (protocol used, prescription of analgesics, side effects, outcome of the abortion).
O0
Nalador, Laboratoire
Schering.
Contraception
549
This multicenter survey was performed in association with six authorized public and private family planning centers*. The survey was conducted over a period of eight months (February 15, 1990 to October 15, 1990). Only 7 people refused to participate. A total of 555 subjects were included, depending on the number of places available in the centers, the criteria for duration of amenorrhoea (42 days at the most to qualify for the legal period in France), and level of literacy (ability to read and write in French). Of this total, 4 women were later excluded following a medical examination which revealed amenorrhea of more than 49 days. Of the remaining 551 subjects, 63 women (1 1%) were lost to followup after their interview with center medical personnel. They may have decided not to terminate their pregnancy or preferred to terminate it elsewhere. This group did not exhibit different characteristics from the rest of the sample concerning age, geographic origin, education, occupation, and had the same distribution pattern in choice of method as the other groups. This group was analyzed separately. Only 396 of the second questionnaires were collected, i.e., 81% of the expected total of 488 (with 64% having had a drug-induced abortion, 27% vacuum aspiration under local anesthesia, and 9% vacuum aspiration under general anesthesia). However, medical forms were collected for all the abortions that were actually performed. Data from the first questionnaire, on the women’s characteristics and selection criteria, were analyzed according to the intended choice entered at the end of the questionnaire. The group of women who expressed “no preference” (NO CHOICE) was kept in the analysis. They were less numerous but sometimes had different characteristics from the other groups. To verify that major differences between groups were not due to the presence of these women, the data were analyzed again without them when necessary. The acceptability of each method (2nd questionnaire) was studied according to the abortion technique used. All of the results were adjusted on the survey site. The statistical tests used were the Chi-square test and the adapted Mantel-Haenszel Chi-square test for comparing percentages (12), and analysis of variance for comparing means. Logistic regression was used for taking into account the influence of the choice criteria. Adjusted odd ratios were calculated as well as 95% confidence intervals. Data were analyzed with SAS software, on VAX 8530 at the INSERM computer centre in Villejuif (France).
*
List of participating centers: Centre d’orthogenie de la Maternite des Lilas (93 Les Lilas), private family
planning center at the Lilas Maternity Hospital Centre d’orthogenie de I’Hopital de Bi&tre (94 le Kremlin Bicetre), public family planning center at the Bicetre Hospital Service de Gyneco-Obstetrique de I’Hbpital de Villeneuve-Saint-Georges (94 Villeneuve-Saint-Georges), public gynecology-obstetrics department at the Villeneuve-Saint-Georges Hospital Centre de Planification de I’Hopital Saint-Jacques (44 Nantes), public family planning center at the Saint-Jacques Hospital Centre d’orthogenie de I’Hopital de la Fraternite (59 Roubaix), public family planning center at the Fraternite Hospital Centre d’orthogenie de I’Hopital J. Ducuing (3 1 Toulouse), private family planning center at the J. Ducuing Hospital.
Contraception
RESULTS
Of the 488 women surveyed in this study, the majority (62%) chose RU 486. Sociodemographic characteristics The four groups of women under consideration (RU, ASPI-LA, ASPI-GA and NO CHOICE) show significant differences in age, education, occupation and geographic origin. Women in the RU and ASPI-GA groups were younger (Table I). A majority of women in the RU (59%) and ASPI-GA (64%) groups were between 14 and 29 years of age. Women in the ASPI-LA group (59%) were older, i.e., 30 years of age or more. This result remains significant if the NO CHOICEgroup is excluded (~~0.01).
TABLEI : INTENDEDCHOICESOF THE WOMENBYAGE GROUP AGEGROUP
NO CHOICERU486 (%)
(%)
AS&LA
ASPI-GA
(%)
(%)
14 - 29 years old
2 30 years old
2446.7)
(2::)
(4&
(6?9)
16 (53.3)
123 (41.3)
(SZ)
(3zs.61) p < 0.05
TOTAL
268 (55.7) 213 (44.3) p < 0.05*
* after adjusting for abortion center. The RU and ASPI-LA groups had higher levels of education (Table II). Of the women who were no longer students, 41% of the RU group and 40% of the ASPI-LA group had had some form of higher education. In the ASPI-GA group, 54% of the women had attended a primary or technical school, and 60% of the NO CHOICEgroup had attended a secondary school (pdO.01). This difference remains significant if the NO CHOICE group is excluded. It is also significant if this comparison is adjusted for age (~~0.05).
Women in the RU group were in a higher occupational class (Table II). They were often “managers or senior personnel” (34%) or “students or seeking employment” (25%). Women in the ASPI-LA group were also “managers or senior personnel” (33%), but differed from the RU group in the number of “ordinary employees or blue collars” (27%). Women in the ASPI-GA group tended to be “ordinaly employees or blue collars” (35%), or “students or seeking employment” (34%). Many of the women in the NO CHOICEgroup were “ordinary employees or blue collars” (36%)(Table II).
551
Contraception TABLE
II: INTENDED CHOlCES OF THE WOMEN BY LEVEL OF EWCATlON AND OCCUPATlON
LEVEL OF EDUCATlON
primary and technical
NO CHOICE w
(2040)
Ru486
ASPI-LA
ASPI-GA
w
w
w
(3::)
(3:;)
(523:)
134 (36.3)
(2::)
(2::)
101 (27.4)
10 (19.2) p < 0.01
secondary (6::) higher
TOTAL
(2040)
95 (40.6)
(3;;)
NO CHOICE
Ru486
ASPI-LA
ASPI-GA
(96)
w
w
(1640)
(lF3)
(2&
(l&)
(1Z)
(20?0)
(2L43)
(l&
(3::)
113 (24.2)
agricultural, small business, shopkeepers
2 (8.0)
(s!s’)
managers or senior personnel
(2czO)
100 (34.1)
(3::)
(I&
141 (30.1)
ordinary employees or blue collars
(369.0)
(2596)
(226.‘6)
(3::)
124 (26.5)
OCCUPATIONAL CLASS
w
134 (36.3) p < 0.01* TOTAL
housewives
students or seeking employment**
(766)
(1.14)
p < 0.01
(5266)
p < o.os*
l
after adjustingfor abortioncenter. ** giventhe low numberof subjects,this groupincludeswomenwho have not yet obtaineda definite occupationor an independentincome.
This difference in distribution appears again if the two largest occupational classes are the only ones considered, i.e., “managers or senior personnel” and “ordinary employees or blue collars”, and the NO CHOICEgroup is excluded (~~0.01). Women in the ASPI-GA group were more often ordinary employees or blue collars (71%). In the RU group (59%) and the ASPI-LA group (55%), they were more often managers or senior personnel. When age is taken into account, the difference in occupational class is only found in women aged 30 or older; most of the younger women were ordinary employees or blue collars, whatever their choice. Age and occupational class were found to be closely related (p
