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Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14–16 weeks
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Abstracts / Contraception 84 (2011) 302–336
clinical benefit of pretreatment with mifepristone in second-trimester misoprostol induction abortion. Methods: The randomized, placebo-controlled, double-blinded trial enrolled 260 women at 14–21 weeks' gestation with a live fetus in Vietnam. Eligible consenting women received either mifepristone or placebo to take at home and returned to the hospital 24 h after mifepristone administration. Women were subsequently administered a 400-mcg dose of buccal misoprostol every 3 h, up to five doses, until both the fetus and placenta were expelled. Women who did not completely evacuate their uterus with the study regimen were offered standard evacuation. Results: Pretreatment with mifepristone resulted in over twice the chance of a complete uterine evaluation vs. misoprostol alone (79.8% vs. 36.9%, RR=2.16; 95% CI: 1.70–2.75). By 10 h after the first dose of misoprostol, more than 60% of women in the mifepristone–misoprostol group had complete uterine evacuation compared to only 10% in the misoprostol-only group. The side effect profiles for the two arms did not differ significantly. Acceptability of the treatment was high for women in both study arms. Conclusions: Mifepristone–misoprostol has higher efficacy, is faster and appears less costly than a misoprostol-only regimen. If possible, medical abortion services should prioritize providing mifepristone to women undergoing second-trimester induction abortion. O5
BUCCAL USE OF MISOPROSTOL ALONE FOR EARLY ABORTION: THE EXPERIENCE IN FOUR LATIN AMERICAN COUNTRIES Sayette H New York, NY, USA Redwine D, Sivin I, Foster-Rosales A, Cullins V Objectives: The increased availability of misoprostol worldwide is expanding access to abortion in low-resource areas. We sought to examine the acceptability, side effects and effectiveness of buccal misoprostol used alone for early abortion in Latin America. Methods: Five reproductive health organizations in four Latin American countries added medication abortion as an alternative to existing early surgical abortion services. Institutional review board approval was received for a retrospective review. Data were collected for all eligible women who requested medication abortion with gestations of 6 to 9 weeks over a 24month period (n=353). Misoprostol 800 mcg was administered buccally at the clinic; this dose was repeated 24 h later at home, with the option of a third dose at follow-up in clinic on day 7. Results: Of 349 women who returned, 319 (91.4%) had a completed abortion; 30 (8.6%) had surgical intervention for incomplete abortion. No serious complications or morbidity was reported. Of those that returned, 82% were satisfied or very satisfied with the process, and 86.6% would recommend misoprostol to a friend. Successful abortion was a key factor in satisfaction with the regimen. Conclusions: A regimen of two to three doses of misoprostol 800 mcg buccally was effective for 91.4% of women at 6 to 9 weeks' gestation. Buccal application of misoprostol for early abortion appears to be a safe, acceptable and effective option in low-resource settings in Latin America. O6
MIFEPRISTONE VS. OSMOTIC DILATOR INSERTION FOR CERVICAL PREPARATION PRIOR TO SURGICAL ABORTION AT 14–16 WEEKS Borgatta L Boston University, Boston, MA, USA Roncari D, Sonalkar S, Mark A, Lifford K, Hou M, Finneseth M
Objectives: Cervical preparation prior to second-trimester surgical abortion can be accomplished by several means. Mifepristone, by softening and dilating the cervix, may be an alternative method. Methods: This was a randomized trial of women requesting abortion at 14 to 16 weeks' gestation. Twenty-four hours prior to surgical evacuation, one group received osmotic dilators and the other group received mifepristone 200 mg orally. The primary outcome was the length of the surgical procedure. Procedure length was expected to be longer in the mifepristone group, and a difference of 3 min was postulated to be a clinically evident change. A noninferiority design was used to determine whether the differential was larger than 3 min. Secondary outcomes included side effects and acceptability. Results: Fifty women were enrolled. The median length of procedure was 7 min in the dilator group and 10 min in the mifepristone group. Most women in the mifepristone group required some mechanical dilation, but the ease of procedure ratings were similar. Overnight cramping occurred in 80% of the dilator group and 36% of the mifepristone group (pb.001). Overnight bleeding was more common in the dilator group, 64% vs. 4% (pb.001). Overnight nausea and/or vomiting occurred in 52% and 60%, respectively (p=.56). In both groups, women preferred the mifepristone technique and would choose it if given the choice. Conclusions: Procedures after mifepristone took 3 min longer than procedures after osmotic dilators, within the acceptable range. Side effects were more frequent and more severe after dilator use. Mifepristone was preferred by women. O7
COMPARISON OF ADVERSE EVENTS IN THE IMMEDIATE PERIOPERATIVE PERIOD (WITHIN 8 WEEKS) AFTER MEDICATION VS. SURGICAL ABORTION Bender N University of Southern California, Los Angeles, CA, USA Lopez Najera S, Nucatola D, Gatter M Objective: The objective was to compare the rates of immediate complications experienced during medication vs. surgical abortions. Methods: This study is a retrospective review of all medication and surgical abortions performed at 63 days' gestation or less in our outpatient facility. All cases performed between January 1, 2004, and December 31, 2010, were identified in our electronic database. Complications occurring within 8 weeks (hemorrhage requiring transfusion, infection requiring hospitalization, incomplete abortion with reaspiration for symptomatic treatment, ongoing pregnancy and perforation) were identified. Statistical analysis was performed using χ2 and Fisher's Exact Test with STATA software. Results: During the study period, 16,924 medication and 33,155 surgical abortions met the inclusion criteria for review. The rate of complications occurring within 8 weeks was 1.9% and 1.0% in the medication and surgical abortion groups, respectively (RR 1.92, pb.0001). Compared to the surgical abortion group, the medication abortion group was more likely to have an ongoing pregnancy (0.3% vs. 0.1%, RR 2.2, p=.0001), need aspiration for incomplete abortion (1.3% vs. 0.7%, RR 1.9, pb.0001), require hospitalization for infection (0.03% vs. 0.006%, RR 4.9, p=.048) or require transfusion for hemorrhage (0.02% vs. 0.003%, RR 7.84, p=.048). The rate of infection before and after the addition of routine antibiotics for medication abortion was not statistically significantly different (0.05% vs. 0.02%, p=.349). Conclusions: Of the 50,079 abortions performed, the rate of complications occurring within 8 weeks was statistically significantly higher in women who had medication compared to surgical abortions. The complication rates were low in both groups and lower than previously reported.
Abstracts / Contraception 84 (2011) 302–336
clinical benefit of pretreatment with mifepristone in second-trimester misoprostol induction abortion. Methods: The randomized, placebo-controlled, double-blinded trial enrolled 260 women at 14–21 weeks' gestation with a live fetus in Vietnam. Eligible consenting women received either mifepristone or placebo to take at home and returned to the hospital 24 h after mifepristone administration. Women were subsequently administered a 400-mcg dose of buccal misoprostol every 3 h, up to five doses, until both the fetus and placenta were expelled. Women who did not completely evacuate their uterus with the study regimen were offered standard evacuation. Results: Pretreatment with mifepristone resulted in over twice the chance of a complete uterine evaluation vs. misoprostol alone (79.8% vs. 36.9%, RR=2.16; 95% CI: 1.70–2.75). By 10 h after the first dose of misoprostol, more than 60% of women in the mifepristone–misoprostol group had complete uterine evacuation compared to only 10% in the misoprostol-only group. The side effect profiles for the two arms did not differ significantly. Acceptability of the treatment was high for women in both study arms. Conclusions: Mifepristone–misoprostol has higher efficacy, is faster and appears less costly than a misoprostol-only regimen. If possible, medical abortion services should prioritize providing mifepristone to women undergoing second-trimester induction abortion. O5
BUCCAL USE OF MISOPROSTOL ALONE FOR EARLY ABORTION: THE EXPERIENCE IN FOUR LATIN AMERICAN COUNTRIES Sayette H New York, NY, USA Redwine D, Sivin I, Foster-Rosales A, Cullins V Objectives: The increased availability of misoprostol worldwide is expanding access to abortion in low-resource areas. We sought to examine the acceptability, side effects and effectiveness of buccal misoprostol used alone for early abortion in Latin America. Methods: Five reproductive health organizations in four Latin American countries added medication abortion as an alternative to existing early surgical abortion services. Institutional review board approval was received for a retrospective review. Data were collected for all eligible women who requested medication abortion with gestations of 6 to 9 weeks over a 24month period (n=353). Misoprostol 800 mcg was administered buccally at the clinic; this dose was repeated 24 h later at home, with the option of a third dose at follow-up in clinic on day 7. Results: Of 349 women who returned, 319 (91.4%) had a completed abortion; 30 (8.6%) had surgical intervention for incomplete abortion. No serious complications or morbidity was reported. Of those that returned, 82% were satisfied or very satisfied with the process, and 86.6% would recommend misoprostol to a friend. Successful abortion was a key factor in satisfaction with the regimen. Conclusions: A regimen of two to three doses of misoprostol 800 mcg buccally was effective for 91.4% of women at 6 to 9 weeks' gestation. Buccal application of misoprostol for early abortion appears to be a safe, acceptable and effective option in low-resource settings in Latin America. O6
MIFEPRISTONE VS. OSMOTIC DILATOR INSERTION FOR CERVICAL PREPARATION PRIOR TO SURGICAL ABORTION AT 14–16 WEEKS Borgatta L Boston University, Boston, MA, USA Roncari D, Sonalkar S, Mark A, Lifford K, Hou M, Finneseth M
Objectives: Cervical preparation prior to second-trimester surgical abortion can be accomplished by several means. Mifepristone, by softening and dilating the cervix, may be an alternative method. Methods: This was a randomized trial of women requesting abortion at 14 to 16 weeks' gestation. Twenty-four hours prior to surgical evacuation, one group received osmotic dilators and the other group received mifepristone 200 mg orally. The primary outcome was the length of the surgical procedure. Procedure length was expected to be longer in the mifepristone group, and a difference of 3 min was postulated to be a clinically evident change. A noninferiority design was used to determine whether the differential was larger than 3 min. Secondary outcomes included side effects and acceptability. Results: Fifty women were enrolled. The median length of procedure was 7 min in the dilator group and 10 min in the mifepristone group. Most women in the mifepristone group required some mechanical dilation, but the ease of procedure ratings were similar. Overnight cramping occurred in 80% of the dilator group and 36% of the mifepristone group (pb.001). Overnight bleeding was more common in the dilator group, 64% vs. 4% (pb.001). Overnight nausea and/or vomiting occurred in 52% and 60%, respectively (p=.56). In both groups, women preferred the mifepristone technique and would choose it if given the choice. Conclusions: Procedures after mifepristone took 3 min longer than procedures after osmotic dilators, within the acceptable range. Side effects were more frequent and more severe after dilator use. Mifepristone was preferred by women. O7
COMPARISON OF ADVERSE EVENTS IN THE IMMEDIATE PERIOPERATIVE PERIOD (WITHIN 8 WEEKS) AFTER MEDICATION VS. SURGICAL ABORTION Bender N University of Southern California, Los Angeles, CA, USA Lopez Najera S, Nucatola D, Gatter M Objective: The objective was to compare the rates of immediate complications experienced during medication vs. surgical abortions. Methods: This study is a retrospective review of all medication and surgical abortions performed at 63 days' gestation or less in our outpatient facility. All cases performed between January 1, 2004, and December 31, 2010, were identified in our electronic database. Complications occurring within 8 weeks (hemorrhage requiring transfusion, infection requiring hospitalization, incomplete abortion with reaspiration for symptomatic treatment, ongoing pregnancy and perforation) were identified. Statistical analysis was performed using χ2 and Fisher's Exact Test with STATA software. Results: During the study period, 16,924 medication and 33,155 surgical abortions met the inclusion criteria for review. The rate of complications occurring within 8 weeks was 1.9% and 1.0% in the medication and surgical abortion groups, respectively (RR 1.92, pb.0001). Compared to the surgical abortion group, the medication abortion group was more likely to have an ongoing pregnancy (0.3% vs. 0.1%, RR 2.2, p=.0001), need aspiration for incomplete abortion (1.3% vs. 0.7%, RR 1.9, pb.0001), require hospitalization for infection (0.03% vs. 0.006%, RR 4.9, p=.048) or require transfusion for hemorrhage (0.02% vs. 0.003%, RR 7.84, p=.048). The rate of infection before and after the addition of routine antibiotics for medication abortion was not statistically significantly different (0.05% vs. 0.02%, p=.349). Conclusions: Of the 50,079 abortions performed, the rate of complications occurring within 8 weeks was statistically significantly higher in women who had medication compared to surgical abortions. The complication rates were low in both groups and lower than previously reported.