- Email: [email protected]
Methotrexate and misoprostol for early abortion: A multicenter trial. Acceptability
Methotrexate and Misoprostol for Early Abortion: A Multicenter Trial. Acceptability Mitchell D. Creinin and Anne E. Burke A prospective trial was conducted including 300 pregnant women seeking elective abortion to evaluate the efficacy and acceptability of methotrexate and misoprostol for abortion at 66 days gestation. Subjects received methotrexate 50 mg/m’ intramuscularly followed 7 days later by misoprostol 800 ,ug vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Efficacy is reported elsewhere. Subjects were questioned before the study as to their reasons for choosing a medical abortion and past experience with surgical abortion. After the study was completed, the women were questioned about their medical abortion experience. All questions were asked in an open-ended manner. Main outcome measuresincluded reasons for abortion and study participation, attitudes about the nonsurgical abortion experience, and feelings about preference of nonsurgical or surgical abortion. The most common reason cited as to why women chose to have a nonsurgical abortion was to avoid some aspect of the surgery (‘48.4%). The percent of women who cited that avoiding surgery was an important reasonin their choice of nonsurgical abortion varied by study site and according to whether the woman had a prior surgical abortion Upon completion of the study, 73.4% of women stated it was a good experience, 19.5% a neutral experience, 7.1% a bad experience, and 1.0% gave no response.When asked what method they would choose if they had to have another abortion, 83.5% would choose this method of medical abortion rather than a surgical abortion. Intramuscular methotrexate and vaginal misoprostol are an acceptable and desirable method of abortion. CONTRACEPTION 1996; 54: 19-22 KEY WORDS: methotrexate,
ceptability
misoprostol,
early abortion, ac-
trial
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pittsburgh, PA, USA Name and address for correspondence: Mitchell D. Creinin. M.D., University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA 15213-3180. Tel: 412-641-1440; Fax: 412-641-1133 Submitted for publication March 26, 1996 Revised April 16, 1996 Accepted for publication April 16, 1996
0 1996 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
Introduction
M
ethotrexate 50 mg/m’ intramuscularly (IM) followed by misoprostol has been shown to induce abortion at ~56 days gestation.’ While the efficacy of this regimen has been established, it must also be acceptable to women for it to be clinically feasible. A single study has reported the acceptability of this treatment regimen in 85 women.’ This report is an analysis of women’s experiences during a large multicenter trial of methotrexate and misoprostol for early abortion.
Materials
and Methods
Healthy English- and Spanish-speaking women were recruited for a multicenter prospective, randomized trial approved by the Human Research Committees of the University of California, San Francisco, and Magee-Womens Hospital. The study sites were San Francisco General Hospital (University of California, San Francisco), Magee-Womens Hospital (University of Pittsburgh), and Women’s Health Care Services in Wichita, Kansas. Patients received methotrexate 50 mg/m’ IM followed by misoprostol800 pg vaginally 7 days later. Misoprostol administration was repeated if the abortion had not occurred after the first dose. The study methods and results are reported elsewhere; 55.7% of the study population had a prior surgical abortion.’ The study was considered to be completed for an individual patient when 1) she had a successful abortion without surgery and completed all followup, or 2) she required a surgical procedure. Participants were not responsible for any costs during study participation. Each patient was interviewed before she received the methotrexate (after informed consent) and after she completed the study. All questions were asked in an open-ended manner. Questions asked of each woman concerned her reasons for wanting an abortion, her reasons for choosing a medical abortion, her prior experience with surgical abortion, and her experience with medical abortion during the study. Before the study began, the following outcomes ISSN OOIO-7824/96/$15.00 PII 80010-7824(96)00114-X
20
Creinin
and Burke
Contraception 1996;54: 19-22
were defined: 1) an abortion would be considered successful if complete abortion occurred without requiring a surgical procedure; 2) immediate success would be a complete abortion passed within 24 hours of the initial or repeat dose of misoprostol; and 3) delayed success would be a complete abortion that occurred more than 24 hours after the repeat dose of misoprostol. Statistical analyses were performed using Chisquare analysis and the Breslow-Day Chi-square analysis for homogeneity with p G 0.05 considered significant.
Results Of 300 women in the multicenter trial, 285 (95.0%) completed both questionnaires and are included in this analysis. The remaining fifteen patients did not complete the post-study questionnaire. Of the 285 women included, 159 (55.8 %) had a prior surgical abortion. The most common reason patients cited for wanting an abortion was not wanting a/another child (63.5%). Other reasons included: financial constraints (35.4%), desire to stay in school (16.5%), problems with partner (16.1% ), “not married” (6.3% J, and medical indication or physician advice (3.9%). Additionally, six women (2.1%) wanted an abortion because the pregnancy was the result of sexual assault, and five women (1.8%) feared losing their jobs if they continued their pregnancies. When the subjects were asked why they opted for a nonsurgical abortion, a total of 437 responses were given (Table 1). The most commonly cited reason was to avoid some aspect of surgical abortion. Of the 170 women who wanted to avoid surgery, 109 (64%) gave a specific reason, including pain/“scraping”/noise of the suction (34.7%), and the emotional stress associated with a surgical abortion (19.4%). Ten women had complications with a prior surgical abortion, and wished to avoid another surgical procedure. InterestTable
1. Reasons why patients
chose to have a medical
Avoid surgery (any aspect) Medical abortion “better” or “easier” Free More natural/like miscarriage Can be done earlier in pregnancy Study will help other women “Try something new” More privacy and control ‘Percent
of subjects
giving
response;
subjects
ingly, eight women specifically cited “avoiding protesters” as a reason to avoid a surgical abortion. Of these, 7 were in Pittsburgh, where the study was offered at a hospital facility that has no regular protesters, unlike the clinics within the city that provide surgical abortions. The eighth woman, however, was in Wichita, where the study site was a free-standing clinic routinely experiencing active protests. The responses of women when asked to give the single main reason for participating in the study are listed in Table 2. Differences between sites were significant when comparing women who cited “to avoid surgery” as their main reason for participation (Table 3). Women in Wichita were most likely to cite “to avoid surgery” if they had not had a prior surgical abortion as compared to women who had this experience (p = 0.011); this difference was not statistically significant at the other two sites. The overall interaction between site and prior surgical abortion is also significant (p = 0.01). The percentage of women citing “cost” as the main reason for participating also differed between sites. In San Francisco, where medical assistance pays for elective abortion, 7 (7.4%) women cited the fact that a medical abortion was free through the study. Comparatively, in Pittsburgh and Wichita, where medical assistance does not pay for elective abortion, 20 (18.3%) women and 17 (21.0%) women, respectively, gave that response. A surgical abortion at 7-12 weeks costs $342 in San Francisco and $350 in Pittsburgh and Wichita. After completing the protocol, women were asked if any aspect of the experience made them feel it was “not worth it” to which 56 (19.6%) assented. For 16 of these women, the abortion “took too long” to occur. Fourteen were unhappy with the degree of cramping, nausea, vomiting, diarrhea, or bleeding they experienced. Ten thought there were “too many appointments” and 9 cited that the medical abortion didn’t work. Two women reported emotional difficulty with
abortion*
Overall
Prior Surgical Abortion
No Prior Surgical Abortion
(N = 285)
(N = 159)
(N = 126)
170 100 49 31 31
98 (61.61
72 43 25 13 17 8 7 0
(59.6) (35.1) (17.2) (11.0) (11.0)
;: 18 14 18 18 4
;z IEi 4 (1:4) could
give
as many
seasons
as they
desired
(total
responses
1E1 (11:3) (8.8) (11.3) (11.3) (2.5) = 437).
157.1) (34.1) (19.8) (10.2) (13.5) (6.3) (5.6)
Contraception 1996;54:19-22
Methotrexate/Misoprostol
2. Primary reasonsfor choice of nonsurgical abortion (%I” Table
Prior Surgical Abortion (N = 159)
No Prior Surgical Abortion (N = 126)
47.8
48.4 2.4
Avoid surgery Study will help other women Free Medical abortion better/safer Can be done earlier in pregnancy More natural/like miscarriage Emotionally easier ‘Includes
only
responses
given
by more
13.2 12.6 12.6
19.0 15.9
5.0 1.3
5.6 3.2 2.4
1.3 than
one
subject.
seeing the tissue pass. Interestingly, of the sixteen women who thought the medical abortion “took too long,” eleven would choose medical abortion over surgical if faced with the decision again. Of the ten who perceived the number of appointments as excessive, seven would choose medical abortion again. However, of the nine women unhappy that the medical abortion failed, only two would choose medical abortion again, and both women who were disturbed by seeing the tissue pass would choose surgical abortion. Of the fourteen women who felt that some type of adverse physical effect made the experience “not worth it,” seven would choose medical abortion and seven would choose surgical if having an abortion in the future. The women were asked: “was the visit schedule a problem for you?” to which 54 (19.8%) responded “yes.” However, 47 (87.0%) of these described their overall experience as positive or neutral, and 39 (72.2%) would still choose medical abortion. When asked to qualify their experiences, 207 (73.4%) called their experiences positive, 55 (19.5%) were neutral, 20 (7.1%) called them negative, and 3 ( 1 .O%) gave no response. Main reasons given for positive and negative responses are listed in Tables 4 and 5, respectively. Patients were asked whether they would choose a 3. Women citing “avoid surgery” as the main reason for having a nonsurgical abortion according to study site
San Francisco Pittsburgh Wichita ‘Study site was a significant for choosing a nonsurgical
No Prior Surgical Abortion*
37/61 (60.6%) 22/51 (43.1%) 17/47 (36.2%)
21/34 (61.2%) 18/58 (31.0%) 22134(64.7%)
predictor abortion
of citing “to avoid (p = 0.001).
surgery”
as a reason
21
4. Main reasonsfor finding their experience “positive” (those cited by more than one respondent)+ Table
% of Women With Positive Experience N = 207
% of Total N = 285
29.8
21.1
18.9 11.4
13.3 8.1
10.4 10.0 3.5 3.5 3.0
7.4 7.0 2.5 2.5 2.1
2.5 1.5 1.5 1.0 1.0
1.8 1.1 1.1 0.7 0.7
Avoid surgical procedure More natural than surgical abortion Liked doctor and staff Easy to tolerate cramping/ pain Emotionally easy More private/personal Study will help other women Few side effects Abortion earlier than with surgery Lessinvasive than surgery Free “Took too long”* * “Didn’t work”* +
*Six questionnaires were not included due to interviewer error. **Despite citing a negative response as their “main reason,” these described their overall experience as positive.
patients
medical or surgical method if they needed an abortion in the future. Overall, 238/285 women, or 83.5%, would choose medical abortion. Of 159 patients who had a prior surgical abortion, 129 (8 1.1%) would choose medical abortion compared to 109/126 (86.5 %) women who had not had a prior surgical abortion (p = 0.23). Of the 207 women with a positive experience, 190 (91.8%) would choose medical abortion again. Forty-two (76.4%) of the 55 patients with a neutral experience would choose medical abortion over surgical, but only G/l8 (30.0%) patients with negative experiences would have a medical abortion again. Of the 33 women who required a surgical procedure to complete the abortion, 19 (57.6%) would still choose medical abortion over surgical. Table
5. Main reasonsfor finding their experience “nega-
tive”*
Table
Prior Surgical Abortion*
for Abortion
% of Women with Negative Experience N = 20
% of Total N = 285
30.0 25.0 25.0 15.0 10.0 5.0
2.1 1.4 1.4 1.1 0.7 0.3
Severe pain or cramping Emotionally hard Required surgical procedure Nausea/vomiting Severe bleeding “Took too long” ‘Includes
only
responses
given
by more
than
one
subject.
22
Creinin
and Burke
Discussion The acceptability of this method of abortion in three different locations was not very different than what had been reported previously for women just from San Francisco.’ It was important to evaluate if the initial acceptability of the method would still be true in other locations with different patient populations. As with the previous report’ and in those reports of acceptability of mifepristone for abortion,3 the main reason that women who participate in these trials feel that a medical option for abortion should be available is because of a desire to avoid some aspect of a surgical procedure. This desire for an alternative is emphasized by the finding that more than half of the women in this trial who needed a surgical abortion still would opt for a nonsurgical abortion if an abortion was needed again in the future. Interestingly, the percentage of women stating that avoiding surgery was the main reason to participate in the trial was different among the three study sites when comparing women who had experienced a surgical abortion in the past and those who had not. The interaction between study site and prior surgical abortion experience demonstrates that the reasons a woman will choose a nonsurgical abortion rather than a surgical abortion will vary by location. The fact that women in Wichita who had a prior surgical abortion were less likely to cite “avoiding surgery” as the main reason to participate in the trial may mean that women in this region of the country have a more positive experience with a surgical abortion compared to women in other regions. In fact, the number of patients at each study site is lowest for Wichita because this study site had the most difficulty recruiting patients; when women were offered this alternative free of charge in Wichita, they still overwhelmingly chose to pay for a surgical procedure which requires fewer visits, has a higher success rate, and has less vaginal bleeding. This suggests that underlying attitudes about the acceptability of surgical abortion will influence whether women will choose this nonsurgical alternative for abortion and that these attitudes will vary across the country. Additionally, 44/285 (15%) of the women stated the
Contraception 1996;54: 19-22
main reason that they participated in the trial was because it was free. The acceptability of the drug regimen in this trial is, therefore, influenced by its availability in a research trial free of charge. When women are given the option in the future to choose between a medical and surgical abortion and they must pay for either, the acceptability will be different. Moreover, the acceptability will be influenced by the cost of the procedure in relation to a surgical procedure. Overall, 93% of subjects in this trial did not have a negative experience and 83.5% would choose the method again. Although the use of methotrexate involves an intramuscular injection as compared to mifepristone which is an oral medication, the acceptability rates are similar. Studies with mifepristone from Sweden,4 and France,’ found an overall positive assessment in 87% and 88%, respectively. In the Swedish study, only 71% of patients said they would choose this method again for a potential next abortion.4 A Chinese study found that 80% of all patients would choose the same treatment again3 This evaluation of acceptability of abortion with methotrexate and misoprostol in this multicenter trial indicates that this regimen will be very acceptable to those women who desire this medical alternative to surgical abortion.
Acknowledgment Eric Vittinghoff,
Ph.D., for his statistical
assistance.
References 1. Creinin MD, Vittinghoff
2. 3. 4. 5.
E, Keder L, Damey PD, Tiller G. Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy. Contraception 1996;53:321-7. Creinin MD, Park M. Acceptability of medical abortion with methotrexate and misoprostol. Contraception 1995j52:41-4. Tang GW, Lau OWK, Yip P. Further acceptability evaluation of RU 486 and ON0 802 as abortifacient agents in a Chinese population. Contraception 1993j48:267-76. Holmgren K. Women’s evaluation of three early abortion methods. Acta Obstet Gynecol Stand 1992j71:616-23. Bachelot A, Cludy L, Spira A. Conditions for choosing between drug-induced and surgical abortions. Contraception 1992;45:547-59.
ceptability
misoprostol,
early abortion, ac-
trial
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pittsburgh, PA, USA Name and address for correspondence: Mitchell D. Creinin. M.D., University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA 15213-3180. Tel: 412-641-1440; Fax: 412-641-1133 Submitted for publication March 26, 1996 Revised April 16, 1996 Accepted for publication April 16, 1996
0 1996 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
Introduction
M
ethotrexate 50 mg/m’ intramuscularly (IM) followed by misoprostol has been shown to induce abortion at ~56 days gestation.’ While the efficacy of this regimen has been established, it must also be acceptable to women for it to be clinically feasible. A single study has reported the acceptability of this treatment regimen in 85 women.’ This report is an analysis of women’s experiences during a large multicenter trial of methotrexate and misoprostol for early abortion.
Materials
and Methods
Healthy English- and Spanish-speaking women were recruited for a multicenter prospective, randomized trial approved by the Human Research Committees of the University of California, San Francisco, and Magee-Womens Hospital. The study sites were San Francisco General Hospital (University of California, San Francisco), Magee-Womens Hospital (University of Pittsburgh), and Women’s Health Care Services in Wichita, Kansas. Patients received methotrexate 50 mg/m’ IM followed by misoprostol800 pg vaginally 7 days later. Misoprostol administration was repeated if the abortion had not occurred after the first dose. The study methods and results are reported elsewhere; 55.7% of the study population had a prior surgical abortion.’ The study was considered to be completed for an individual patient when 1) she had a successful abortion without surgery and completed all followup, or 2) she required a surgical procedure. Participants were not responsible for any costs during study participation. Each patient was interviewed before she received the methotrexate (after informed consent) and after she completed the study. All questions were asked in an open-ended manner. Questions asked of each woman concerned her reasons for wanting an abortion, her reasons for choosing a medical abortion, her prior experience with surgical abortion, and her experience with medical abortion during the study. Before the study began, the following outcomes ISSN OOIO-7824/96/$15.00 PII 80010-7824(96)00114-X
20
Creinin
and Burke
Contraception 1996;54: 19-22
were defined: 1) an abortion would be considered successful if complete abortion occurred without requiring a surgical procedure; 2) immediate success would be a complete abortion passed within 24 hours of the initial or repeat dose of misoprostol; and 3) delayed success would be a complete abortion that occurred more than 24 hours after the repeat dose of misoprostol. Statistical analyses were performed using Chisquare analysis and the Breslow-Day Chi-square analysis for homogeneity with p G 0.05 considered significant.
Results Of 300 women in the multicenter trial, 285 (95.0%) completed both questionnaires and are included in this analysis. The remaining fifteen patients did not complete the post-study questionnaire. Of the 285 women included, 159 (55.8 %) had a prior surgical abortion. The most common reason patients cited for wanting an abortion was not wanting a/another child (63.5%). Other reasons included: financial constraints (35.4%), desire to stay in school (16.5%), problems with partner (16.1% ), “not married” (6.3% J, and medical indication or physician advice (3.9%). Additionally, six women (2.1%) wanted an abortion because the pregnancy was the result of sexual assault, and five women (1.8%) feared losing their jobs if they continued their pregnancies. When the subjects were asked why they opted for a nonsurgical abortion, a total of 437 responses were given (Table 1). The most commonly cited reason was to avoid some aspect of surgical abortion. Of the 170 women who wanted to avoid surgery, 109 (64%) gave a specific reason, including pain/“scraping”/noise of the suction (34.7%), and the emotional stress associated with a surgical abortion (19.4%). Ten women had complications with a prior surgical abortion, and wished to avoid another surgical procedure. InterestTable
1. Reasons why patients
chose to have a medical
Avoid surgery (any aspect) Medical abortion “better” or “easier” Free More natural/like miscarriage Can be done earlier in pregnancy Study will help other women “Try something new” More privacy and control ‘Percent
of subjects
giving
response;
subjects
ingly, eight women specifically cited “avoiding protesters” as a reason to avoid a surgical abortion. Of these, 7 were in Pittsburgh, where the study was offered at a hospital facility that has no regular protesters, unlike the clinics within the city that provide surgical abortions. The eighth woman, however, was in Wichita, where the study site was a free-standing clinic routinely experiencing active protests. The responses of women when asked to give the single main reason for participating in the study are listed in Table 2. Differences between sites were significant when comparing women who cited “to avoid surgery” as their main reason for participation (Table 3). Women in Wichita were most likely to cite “to avoid surgery” if they had not had a prior surgical abortion as compared to women who had this experience (p = 0.011); this difference was not statistically significant at the other two sites. The overall interaction between site and prior surgical abortion is also significant (p = 0.01). The percentage of women citing “cost” as the main reason for participating also differed between sites. In San Francisco, where medical assistance pays for elective abortion, 7 (7.4%) women cited the fact that a medical abortion was free through the study. Comparatively, in Pittsburgh and Wichita, where medical assistance does not pay for elective abortion, 20 (18.3%) women and 17 (21.0%) women, respectively, gave that response. A surgical abortion at 7-12 weeks costs $342 in San Francisco and $350 in Pittsburgh and Wichita. After completing the protocol, women were asked if any aspect of the experience made them feel it was “not worth it” to which 56 (19.6%) assented. For 16 of these women, the abortion “took too long” to occur. Fourteen were unhappy with the degree of cramping, nausea, vomiting, diarrhea, or bleeding they experienced. Ten thought there were “too many appointments” and 9 cited that the medical abortion didn’t work. Two women reported emotional difficulty with
abortion*
Overall
Prior Surgical Abortion
No Prior Surgical Abortion
(N = 285)
(N = 159)
(N = 126)
170 100 49 31 31
98 (61.61
72 43 25 13 17 8 7 0
(59.6) (35.1) (17.2) (11.0) (11.0)
;: 18 14 18 18 4
;z IEi 4 (1:4) could
give
as many
seasons
as they
desired
(total
responses
1E1 (11:3) (8.8) (11.3) (11.3) (2.5) = 437).
157.1) (34.1) (19.8) (10.2) (13.5) (6.3) (5.6)
Contraception 1996;54:19-22
Methotrexate/Misoprostol
2. Primary reasonsfor choice of nonsurgical abortion (%I” Table
Prior Surgical Abortion (N = 159)
No Prior Surgical Abortion (N = 126)
47.8
48.4 2.4
Avoid surgery Study will help other women Free Medical abortion better/safer Can be done earlier in pregnancy More natural/like miscarriage Emotionally easier ‘Includes
only
responses
given
by more
13.2 12.6 12.6
19.0 15.9
5.0 1.3
5.6 3.2 2.4
1.3 than
one
subject.
seeing the tissue pass. Interestingly, of the sixteen women who thought the medical abortion “took too long,” eleven would choose medical abortion over surgical if faced with the decision again. Of the ten who perceived the number of appointments as excessive, seven would choose medical abortion again. However, of the nine women unhappy that the medical abortion failed, only two would choose medical abortion again, and both women who were disturbed by seeing the tissue pass would choose surgical abortion. Of the fourteen women who felt that some type of adverse physical effect made the experience “not worth it,” seven would choose medical abortion and seven would choose surgical if having an abortion in the future. The women were asked: “was the visit schedule a problem for you?” to which 54 (19.8%) responded “yes.” However, 47 (87.0%) of these described their overall experience as positive or neutral, and 39 (72.2%) would still choose medical abortion. When asked to qualify their experiences, 207 (73.4%) called their experiences positive, 55 (19.5%) were neutral, 20 (7.1%) called them negative, and 3 ( 1 .O%) gave no response. Main reasons given for positive and negative responses are listed in Tables 4 and 5, respectively. Patients were asked whether they would choose a 3. Women citing “avoid surgery” as the main reason for having a nonsurgical abortion according to study site
San Francisco Pittsburgh Wichita ‘Study site was a significant for choosing a nonsurgical
No Prior Surgical Abortion*
37/61 (60.6%) 22/51 (43.1%) 17/47 (36.2%)
21/34 (61.2%) 18/58 (31.0%) 22134(64.7%)
predictor abortion
of citing “to avoid (p = 0.001).
surgery”
as a reason
21
4. Main reasonsfor finding their experience “positive” (those cited by more than one respondent)+ Table
% of Women With Positive Experience N = 207
% of Total N = 285
29.8
21.1
18.9 11.4
13.3 8.1
10.4 10.0 3.5 3.5 3.0
7.4 7.0 2.5 2.5 2.1
2.5 1.5 1.5 1.0 1.0
1.8 1.1 1.1 0.7 0.7
Avoid surgical procedure More natural than surgical abortion Liked doctor and staff Easy to tolerate cramping/ pain Emotionally easy More private/personal Study will help other women Few side effects Abortion earlier than with surgery Lessinvasive than surgery Free “Took too long”* * “Didn’t work”* +
*Six questionnaires were not included due to interviewer error. **Despite citing a negative response as their “main reason,” these described their overall experience as positive.
patients
medical or surgical method if they needed an abortion in the future. Overall, 238/285 women, or 83.5%, would choose medical abortion. Of 159 patients who had a prior surgical abortion, 129 (8 1.1%) would choose medical abortion compared to 109/126 (86.5 %) women who had not had a prior surgical abortion (p = 0.23). Of the 207 women with a positive experience, 190 (91.8%) would choose medical abortion again. Forty-two (76.4%) of the 55 patients with a neutral experience would choose medical abortion over surgical, but only G/l8 (30.0%) patients with negative experiences would have a medical abortion again. Of the 33 women who required a surgical procedure to complete the abortion, 19 (57.6%) would still choose medical abortion over surgical. Table
5. Main reasonsfor finding their experience “nega-
tive”*
Table
Prior Surgical Abortion*
for Abortion
% of Women with Negative Experience N = 20
% of Total N = 285
30.0 25.0 25.0 15.0 10.0 5.0
2.1 1.4 1.4 1.1 0.7 0.3
Severe pain or cramping Emotionally hard Required surgical procedure Nausea/vomiting Severe bleeding “Took too long” ‘Includes
only
responses
given
by more
than
one
subject.
22
Creinin
and Burke
Discussion The acceptability of this method of abortion in three different locations was not very different than what had been reported previously for women just from San Francisco.’ It was important to evaluate if the initial acceptability of the method would still be true in other locations with different patient populations. As with the previous report’ and in those reports of acceptability of mifepristone for abortion,3 the main reason that women who participate in these trials feel that a medical option for abortion should be available is because of a desire to avoid some aspect of a surgical procedure. This desire for an alternative is emphasized by the finding that more than half of the women in this trial who needed a surgical abortion still would opt for a nonsurgical abortion if an abortion was needed again in the future. Interestingly, the percentage of women stating that avoiding surgery was the main reason to participate in the trial was different among the three study sites when comparing women who had experienced a surgical abortion in the past and those who had not. The interaction between study site and prior surgical abortion experience demonstrates that the reasons a woman will choose a nonsurgical abortion rather than a surgical abortion will vary by location. The fact that women in Wichita who had a prior surgical abortion were less likely to cite “avoiding surgery” as the main reason to participate in the trial may mean that women in this region of the country have a more positive experience with a surgical abortion compared to women in other regions. In fact, the number of patients at each study site is lowest for Wichita because this study site had the most difficulty recruiting patients; when women were offered this alternative free of charge in Wichita, they still overwhelmingly chose to pay for a surgical procedure which requires fewer visits, has a higher success rate, and has less vaginal bleeding. This suggests that underlying attitudes about the acceptability of surgical abortion will influence whether women will choose this nonsurgical alternative for abortion and that these attitudes will vary across the country. Additionally, 44/285 (15%) of the women stated the
Contraception 1996;54: 19-22
main reason that they participated in the trial was because it was free. The acceptability of the drug regimen in this trial is, therefore, influenced by its availability in a research trial free of charge. When women are given the option in the future to choose between a medical and surgical abortion and they must pay for either, the acceptability will be different. Moreover, the acceptability will be influenced by the cost of the procedure in relation to a surgical procedure. Overall, 93% of subjects in this trial did not have a negative experience and 83.5% would choose the method again. Although the use of methotrexate involves an intramuscular injection as compared to mifepristone which is an oral medication, the acceptability rates are similar. Studies with mifepristone from Sweden,4 and France,’ found an overall positive assessment in 87% and 88%, respectively. In the Swedish study, only 71% of patients said they would choose this method again for a potential next abortion.4 A Chinese study found that 80% of all patients would choose the same treatment again3 This evaluation of acceptability of abortion with methotrexate and misoprostol in this multicenter trial indicates that this regimen will be very acceptable to those women who desire this medical alternative to surgical abortion.
Acknowledgment Eric Vittinghoff,
Ph.D., for his statistical
assistance.
References 1. Creinin MD, Vittinghoff
2. 3. 4. 5.
E, Keder L, Damey PD, Tiller G. Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy. Contraception 1996;53:321-7. Creinin MD, Park M. Acceptability of medical abortion with methotrexate and misoprostol. Contraception 1995j52:41-4. Tang GW, Lau OWK, Yip P. Further acceptability evaluation of RU 486 and ON0 802 as abortifacient agents in a Chinese population. Contraception 1993j48:267-76. Holmgren K. Women’s evaluation of three early abortion methods. Acta Obstet Gynecol Stand 1992j71:616-23. Bachelot A, Cludy L, Spira A. Conditions for choosing between drug-induced and surgical abortions. Contraception 1992;45:547-59.