Comparison of 400 mcg buccal and 400 mcg sublingual misoprostol after mifepristone medical abortion through 63 days' LMP: a randomized controlled trial

BackgroundBuccal misoprostol 800 mcg and sublingual misoprostol 400 mcg demonstrate high efficacy and few adverse effects when used with 200 mg mifepristone for medical abortion through 63 days since the last menstrual period (LMP). Little is known about a 400-mcg buccal dose. This study compares two in-the-mouth routes of misoprostol using the same dose.Study DesignEligible and consenting women (n=550) were randomized to 400 mcg of misoprostol buccally or sublingually 24 h after ingestion of 200 mg of mifepristone. Abortion status was assessed 2 weeks later.ResultsComplete abortion occurred in 97.1% of the buccal group and 97.4% of the sublingual group (p=.97, RR: 1.00, 95% CI=0.97–1.03). Adverse effects were similar in both groups. Over 90% of women in both arms expressed high satisfaction with the method.ConclusionsBoth 400 mcg buccal misoprostol and 400 mcg sublingual misoprostol after mifepristone appear to be good options for medical abortion through 63 days' LMP.     

A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion

BackgroundAn 800-mcg dose of buccal misoprostol following mifepristone has been shown to be highly effective in terminating pregnancies through 63 days since the last menstrual period (LMP) (B. Winikoff, I.G. Dzuba, M.D. Creinin, et al., Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol 2008; 112: 1303–1310). However, a two 200-mcg misoprostol pill option would simplify administration, and potentially reduce costs and increase women's satisfaction. This study compares a 400-mcg dose (Group I) to an 800-mcg dose (Group II) of buccal misoprostol.Study DesignEligible and consenting women requesting medical termination of early pregnancy (n=1122) were randomized and instructed to take misoprostol 36 to 48 h after taking 200 mg mifepristone. Follow-up visits occurred 12 to 15 days after mifepristone administration.ResultsNinety-six percent of women in both groups had successful abortions. Women in Group I experienced significantly less vomiting and fever/chills than women in Group II. Ninety-six percent of women in both groups found the procedure very satisfactory or satisfactory.ConclusionsFour hundred micrograms of buccal misoprostol is as effective as the standard 800-mcg dose in terminating pregnancies up to 63 days LMP and reduces side effects.     

A two-pill sublingual misoprostol outpatient regimen following mifepristone for medical abortion through 70 days' LMP: a prospective comparative open-label trial

Objective

To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64–70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57–63 days' LMP gestational age range.

Study Design

We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point.

Results

A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups [57–63-day group: 94·8%; 64–70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61–1.04)]. Ongoing pregnancy rates also did not differ significantly (57–63 days: 1.8%; 64–70 days: 2.2%; RR: 1.10 (0.65–1.87)].

Conclusion

A medical abortion regimen of 200 mg mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services.

Implications

A regimen of 200 mg mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.     

Two-pill regimens of misoprostol after mifepristone medical abortion through 63 days' gestational age: a randomized controlled trial of sublingual and oral misoprostol

Background

A 400 mcg dose of sublingual misoprostol has high efficacy and few side effects when used with 200 mg mifepristone for medical abortion through 63 days' gestation.

Study Design

Eligible and consenting women (n=480) were randomized to 400 mcg of misoprostol sublingually or orally, 24 h after 200 mg of mifepristone. Abortion status was assessed two weeks later.

Results

Complete abortion occurred in 98.7% of the sublingual group and 94.0% of the oral group (p value=.006, RR: 1.05, 95% CI=1.01--1.09). Over 90% of women in both arms expressed high satisfaction with the method. Side effects were similar in both groups, with only fever or chills reported by significantly more women in the sublingual arm.

Conclusions

The sublingual route appears superior to the regimen of 400 mcg misoprostol used orally and may be a good option for mifepristone medical abortion.     

Early abortion with buccal versus sublingual misoprostol alone: a multicenter,randomized trial

ObjectiveTo compare efficacy, safety/side effects and acceptability of buccal versus sublingual administration of a misoprostol-only regimen commonly used for early medical abortion.Study designWe conducted a randomized trial at six clinics in two Latin American countries. We randomized women seeking early abortion to buccal or sublingual administration of three doses of misoprostol 800 mcg repeated every 3 h. At initial follow-up (7–14 days after misoprostol), we offered women without a complete abortion aspiration or additional misoprostol plus waiting 7 more days. The primary outcome was continuing pregnancy at initial follow-up. Secondary outcomes included continuing pregnancy at final follow-up, incomplete abortion, successful abortion, side effects, acceptability and complications. We analyzed all outcomes as intention to treat.ResultsWe enrolled 401 women and randomized 202 into the buccal arm and 199 into the sublingual arm. Continuing pregnancy at initial follow-up occurred in 11/201 (5.5%) and 2/189 (1.1%) women, respectively (p=.02). Additional misoprostol at follow-up increased success, defined as complete abortion, from 170/201 (84.6%) to 184/199 (92.5%) in the buccal arm and 165/189 (87.3%) to 177/189 (93.7%) in the sublingual arm. We found no differences by gestational age. Women reported similar acceptability and side effects across groups except for chills and fever, which women using sublingual misoprostol reported more frequently (p<.05).ConclusionsSublingual administration was superior to buccal administration in reducing continuing pregnancy risk after a three-dose regimen of 800 mcg misoprostol. Complete abortion rates were comparable across groups, and in both cases, additional misoprostol at follow-up increased success.ImplicationsIf the primary goal is to avoid continuing pregnancy, sublingual administration of misoprostol 800 mcg every 3 h for three doses should be recommended. If chills or fever are a concern and the primary goal is to avoid surgery, buccal administration may be preferable. For either route, additional misoprostol can be given for incomplete abortion or continuing pregnancy.     

Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone

Background

Nonsurgical abortion methods have the potential to improve access to high-quality abortion care. Until recently, availability and utilization of mifepristone medical abortion in low-resource countries were restricted due to the limited availability and perceived high cost of mifepristone, leading some providers and policymakers to support use of misoprostol-only regimens. Yet, this may not be desirable if misoprostol-only regimens are considerably less effective and ultimately more costly for health care systems. This study sought to document the differences in efficacy between two nonsurgical abortion regimens.

Study Design

This double-blind randomized placebo-controlled trial enrolled women with gestational ages up to 63 days seeking early medical abortion from August 2007 to March 2008 at a large tertiary hospital in Ho Chi Minh City, Vietnam. Eligible consenting women received either (1) two doses of 800 mcg buccal misoprostol 24 h apart or (2) 200 mg mifepristone and 800 mcg buccal misoprostol 24 h later. Participants self-administered all study drugs and returned to the hospital for follow-up 1 week later. The trial is registered at ClinicalTrials.gov as NCT00680394.

Results

Four hundred women were randomized to either misoprostol-only (198) or mifepristone+misoprostol (202). Complete abortion occurred for 76.2% (n=147) of women allocated to misoprostol-only vs. 96.5% (n=194) of those given mifepristone+misoprostol (RR 0.79, 95% CI 0.73–0.86). Ongoing pregnancy was documented for 16.6% (32) of misoprostol-only users and 1.5% (3) of mifepristone+misoprostol users (1.62, 0.68–3.90). Side effects were generally similar for both groups, although significantly more women allocated to misoprostol-only reported diarrhea.

Conclusions

Mifepristone+misoprostol is significantly more effective than use of misoprostol-alone for early medical abortion. The number of ongoing pregnancies documented with misoprostol-only warranted an early end of the trial after unblinding of the study at interim analysis. Policymakers should advocate for greater access to mifepristone. Future research should prioritize misoprostol-only regimens with shorter dosing intervals.     

Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days

Background

From 2001 to March 2006, Planned Parenthood Federation of America (Planned Parenthood) health centers throughout the United States provided medical abortions principally by a regimen of oral mifepristone, followed 24-48 h later by vaginal misoprostol. In late March 2006, analyses of serious uterine infections following medical abortions led Planned Parenthood to change the route of misoprostol administration and to employ additional measures to minimize subsequent serious uterine infections. In August 2006, we conducted an extensive audit of medical abortions with the new buccal misoprostol regimen so that patients could be given accurate information about the success rate of the new regimen.

Objectives

We sought to evaluate the effectiveness of the buccal medical abortion regimen and to examine correlates of its success during routine service delivery.

Methods

In 2006, audits were conducted in 10 large urban service points to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. These audits also permitted estimates of success rates with oral misoprostol following mifepristone in a subset in which 98% of the subjects stemmed from two sites.

Results

The effectiveness of the buccal misoprostol-mifepristone regimen was 98.3% for women with gestational ages below 60 days. The oral misoprostol-mifepristone regimen, used by 278 women with a gestational age below 50 days, had a success rate of 96.8%.

Conclusion

In conjunction with 200 mg of mifepristone, use of 800 mcg of buccal misoprostol up to 59 days of gestation is as effective as the use of 800 mcg of vaginal misoprostol up to 63 days of gestation.     

米非司酮配伍米索前列醇不同给药方式终止早孕的临床随机比较研究

目的研究米非司酮配伍米索前列醇舌下含服及口服的药物流产效果。方法将158例早孕妇女(停经≤56天)随机分为2组,连续口服米非司酮2天,3次/d,每次25mg,第3天上午使用米索前列醇(本文简称米索)口服400μg同时阴道给400μg(组Ⅰ),或者舌下含400μg同时阴道给400μg(组Ⅱ)以终止妊娠。结果总体完全流产率为94.9%,组I为92.5%,组Ⅱ为97.4%,两组无显著性差异(P>0.05);总体不全流产率为4.43%,组I为7.5%(6/80),高于组Ⅱ1.28%(1/78),但两组无显著性差异(P>0.05);总体失败率为0.63%,其中组Ⅰ为0,组Ⅱ为1.28%,两组亦无显著性差异(P>0.05);组Ⅰ从应用米索至孕囊排出时间为(2.39±1.20)h,明显低于组Ⅱ(2.98±1.33)h(P<0.01)。结论组I终止早孕的不全流产率高于组Ⅱ(但无明显组间差异,可能与样本较小有关),可能与舌下含服米索可使有效血药浓度维持时间较长,生物利用度较高有关,故在药物流产中米非司酮配伍舌下含服米索是1种很有前景的用药方法。     

Two routes of administration for misoprostol in the treatment of incomplete abortion: a randomized clinical trial

Background

This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of incomplete abortion.

Study Design

We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed incomplete abortion with uterine size ≤12 weeks since last menstrual period were randomized to misoprostol either 600 mcg orally or 400 mcg sublingually. The primary outcome measure was the complete resolution of clinical signs and symptoms of incomplete abortion without need for surgical intervention. Women were seen for follow-up on Day 7 and, if necessary, on Day 14 to assess abortion status. The study was powered to detect a 7% difference in efficacy with a total of 142 women required in each arm.

Results

Efficacy rates were 94.6% and 94.5%, for the oral and sublingual routes, respectively (RR: 1.00, 95% CI=0.95–1.06, p=.98). At 1 week follow-up, more than 80% of women had completed abortions (77.8% oral and 84.8% sublingual, p=.12). Mean pain scores were 2.95 and 3.04, respectively, for the oral and sublingual groups. Side effects included abdominal pain, bleeding, headaches and dizziness/weakness with no differences reported between the two groups. Acceptability and satisfaction were high for both routes and women indicated a preference for medical versus surgical treatment if ever needed in the future.

Conclusions

Both treatment regimens were very effective. Four hundred micrograms of sublingual misoprostol and 600 mcg oral misoprostol appear to have similar safety and effectiveness profiles when used for the treatment of incomplete abortion. A lower 400-mcg misoprostol dose may provide an alternative treatment option as well as have potential benefits in terms of cost.     

Oral mifepristone and buccal misoprostol administered simultaneously for abortion: a pilot study

BACKGROUND: Simultaneous oral mifepristone and vaginal misoprostol has a 24-h expulsion rate of approximately 90% when used for abortion through 63 days' gestation. This pilot study sought to determine if a simultaneous regimen using buccal misoprostol would be similarly effective and merit further investigation. STUDY DESIGN: One hundred twenty women were enrolled into three equal groups by gestational age: < or =49 days (Group 1), 50-56 days (Group 2) and 57-63 days (Group 3). After swallowing 200 mg of mifepristone, subjects received 800 mcg buccal misoprostol. Participants returned in 24+/-1 h for evaluation of expulsion by ultrasonography. Women with a persistent gestational sac received 800 mcg vaginal misoprostol. Further follow-up occurred at 1, 2 and 5 weeks by telephone or in person, as appropriate. Sample sizes for each group were estimated with the aim of establishing a 24-h expulsion rate of 90% (95% CI=76-95). RESULTS: The 24-h expulsion rates for Groups 1, 2 and 3 were 73% (95% CI=56-85), 69% (95% CI=52-83) and 73% (95% CI=56-85), respectively. Common side effects were nausea (62%), vomiting (33%) and diarrhea (48%), which did not differ by gestational age. Forty-three percent of subjects found the taste of buccal misoprostol objectionable; 30% found buccal retention uncomfortable or inconvenient, and 10% reported oral irritation, sensitivity, numbness or oral ulcers. CONCLUSIONS: Simultaneous oral mifepristone and buccal misoprostol had a lower-than-hypothesized expulsion rate at 24 h. Although overall success rates at 7 or 15 days could have been higher than those observed at 24 h, we believe that this regimen does not warrant further study.     

Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion.

Mifepristone was recently approved in the United States. Regimens with shorter intervals may be more acceptable. The objective of this study was to determine whether the oral route of misoprostol was as effective as the vaginal route of misoprostol 1 day after mifepristone. A prospective, open-labeled, randomized trial of healthy adult women up to 63 days pregnant and wanting a medical abortion were randomized to use either two doses of oral misoprostol 400 microg taken 2 h apart or misoprostol 800 microg vaginally. Women self-administered misoprostol 1 day after taking one-third of the standard dose of mifepristone (200 mg) orally. Women then returned to the clinic up to 5 days later for a repeat sonogram evaluation. A dose of vaginal misoprostol was administered to women with a continuing pregnancy who then returned 1 day later to Day 15. The primary outcome measures were a complete medical abortion by the first or by the second follow-up visits. Surgical intervention was indicated for continuing pregnancy at the second follow-up visit, excessive bleeding, or persistent products of conception 5 weeks later. One thousand one hundred sixty-eight women were enrolled. Of the 1144 (98%) women who complied with their random assignment, two oral doses of misoprostol (800 microg total) were 90% effective at inducing an abortion by the first follow-up visit, compared with one dose of misoprostol by vagina of 97% (chi(2) = 23.95, p = 0.001). By the second follow-up visit, the complete abortion rate was 95% for oral misoprostol and 99% for vaginal misoprostol (chi(2) = 21.76, p = 0.001). There were minimal differences in side effects. Women preferred the oral route. The trial demonstrated that although two doses of oral misoprostol were effective, the vaginal misoprostol was more effective at inducing an early medical abortion at 1 day after low-dose mifepristone, and the regimen could be extended to 63 days gestation.     

Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days

The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.     

Can women accurately assess the outcome of medical abortion based on symptoms alone?

BackgroundThe primary purpose of this study was to evaluate whether women undergoing medical abortion can accurately assess abortion outcome based on symptoms alone. Our secondary aim was to identify predictors of medical abortion failure.Study DesignWe conducted a case–control study of women undergoing medical abortion from January 1, 2004, to December 31, 2005, who were 63 days' gestation or less and received 200 mg mifepristone followed by 800 mcg of vaginal misoprostol 6–72 h later. Cases were defined as women who required uterine evacuation for a retained gestational sac or ongoing pregnancy. Separate analyses were conducted for the subset of cases with ongoing pregnancies. Controls were defined as women who successfully expelled the pregnancy without uterine evacuation.ResultsDuring the study period, 53 women had a retained gestational sac (N=26) or ongoing pregnancy (N=27), and a total of 53 controls were selected, matched by site and date of procedure. Case subjects were more likely than controls to report minimal vaginal bleeding and ongoing pregnancy symptoms and to express doubt that they expelled the pregnancy. When predictive modeling was performed, ongoing pregnancy symptoms, minimal bleeding and gestational age as determined by ultrasound measurement of gestational sac or crown-rump length accurately identified only 68% of medical abortion failures. We also found that the odds of medical abortion failure decreased progressively from approximately 4 to 7 weeks' gestational age, was lowest at approximately 7 weeks and increased from 7 to 9 weeks' gestation.ConclusionPatient symptomatology and self-assessment of complete abortion alone are moderately useful in identifying medical abortion failure. An objective measure of complete abortion, such as a pregnancy test, is still required.     

Outcomes of medical abortion through 63 days in women with twin gestations

Background

Twin gestation is not considered a contraindication to medical abortion with mifepristone and misoprostol. However, data comparing the efficacy of medical abortion for singleton gestations as compared with multiple gestations are limited. We examined medical abortion outcomes for twin gestations through 63 days.

Study Design

We performed a secondary analysis of treatment efficacy and side effects using pooled data from two randomized medical abortion trials. All subjects received mifepristone 200 mg orally and misoprostol 800 mcg vaginally. Outcomes in women with singleton and twin gestations were compared.

Results

Of 2208 subjects, 24 (1.1%) women had twins. Treatment success was not statistically different for twin and singleton gestations (91% vs. 97%, p=.19). Perceived bleeding and pain were not significantly different between groups.

Conclusions

Treatment success of medical abortion for twins is not significantly different than for singletons, although small differences cannot be excluded due to the limited number of twins.     

A pilot study on the use of letrozole with either misoprostol or mifepristone for termination of pregnancy up to 63 days

Background

Letrozole is a third-generation selective aromatase inhibitor. Animal data suggested that it might be useful in medical abortion. We performed two pilot studies to assess the feasibility of using letrozole in combination with either mifepristone or misoprostol for termination of pregnancy up to 63 days.

Study Design

We recruited 40 subjects who requested legal termination of pregnancies up to 63 days. Medical abortion was performed with letrozole 7.5 mg daily for 2 days followed by 800 mcg vaginal misoprostol in 20 subjects and letrozole 7.5 mg combined with 200 mg mifepristone in another 20 subjects.

Results

The mean induction-to-abortion interval of the regimen of letrozole and misoprostol was 9.1 h (median 7.9 h, range 2.7–23.6 h). The complete abortion rate was 80% (95% CI: 56.3–94.3%). For those with gestation of ≤49 days, the complete abortion rate was 87.5% (14/16; 95% CI: 61.7–98.5%). The mean induction-to-abortion interval of letrozole combined with mifepristone was 90.1 h (median 93.4 h, range 66.0–121.2 h). The complete abortion rate was 71.4% (95% CI: 47.8–88.7%).

Conclusion

These preliminary results suggest that a regimen of letrozole and misoprostol may be useful in medical abortion, but the combination with mifepristone is less effective and takes longer. Randomized studies comparing letrozole and misoprostol to misoprostol alone are warranted.     

Mifepristone and misoprostol for the treatment of early pregnancy failure: a pilot clinical trial

BackgroundIn an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 μg, vaginally (pv), for the treatment of EPF.MethodsWe enrolled 30 women with EPF in this pilot clinical trial. All women used misoprostol 800 μg, pv, 24 h after ingesting 200 mg mifepristone. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 1 week after treatment. Participants were offered a repeat dose of misoprostol if the pregnancy had not been expelled at the first follow-up.ResultsThe expulsion rate with one dose of misoprostol was 90% (95% CI=79–100%). The overall success rate of the treatment was 93% (95% CI=84–100%).ConclusionThis regimen of mifepristone followed by vaginal misoprostol appears to be an efficacious and acceptable treatment for EPF and may have improved results over a single dose of misoprostol alone.     

A pilot study on the use of a 7-day course of letrozole followed by misoprostol for the termination of early pregnancy up to 63 days

BackgroundOur previous randomized controlled study showed that the complete abortion rate in termination of pregnancy up to 63 days with the combined use of letrozole for 3 days followed by vaginal misoprostol was significantly higher than that of misoprostol alone. A positive correlation was observed between the basal estradiol level and the failure rate. We performed this pilot study to assess if a longer course of letrozole followed by misoprostol would improve the estradiol suppression and the complete abortion rate of pregnancy up to 63 days.Study DesignTwenty subjects requesting legal termination of pregnancies up to 63 days were recruited. Medical abortion was offered with letrozole 10 mg daily for 7 days followed by vaginal misoprostol 800 mcg on the 7th day.ResultsMedian induction-to-abortion interval was 7.5 h (range, 4.75–10.75 h). Overall complete abortion rate was 95%. All subjects with gestation ≤ 49 days (12/12) as well as 87.5% of subjects with gestation between 50 and 63 days (7/8) had complete abortion. No major adverse event were reported and over 88% of women would like to have medical termination as an option should it be required in the future.ConclusionThis pilot study showed that a 7-day course of letrozole followed by vaginal misoprostol was associated with a very high complete abortion rate (95%) which is comparable to the standard regimen with sequential use of mifepristone and misoprostol in medical termination of early pregnancy up to 63 days.     

Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period

OBJECTIVE: Mifepristone-misoprostol medical abortion has been approved in the United States since 2000. U.S. providers have preferred to use vaginal misoprostol because of evidence that such a regimen is more effective in later gestations. Buccal administration of misoprostol may be equally effective and more acceptable to some women. METHODS: This open-label, randomized trial was conducted at two sites in Rochester, NY, and involved healthy women with pregnancies through 56 days since the last menstrual period (LMP) as indicated by sonogram. Women received mifepristone 200 mg orally and were randomized to use 800 mug of misoprostol either buccally or vaginally 1 to 2 days later. They returned within 15 days for repeat sonogram. If the woman's pregnancy had not been completely aborted by day 36, a suction abortion was performed. The primary outcome was a complete abortion without surgical intervention. RESULTS: Four hundred forty-two women were enrolled in the study, and complete data were available on 429. The efficacy rate was 95% (205/216) in the buccal group and 93% (199/213) in the vaginal group (chi(2)=0.43, p=.51). Nausea was the most commonly reported side effect, affecting 70% in the buccal group and 62% in the vaginal group. There were no differences in the satisfaction with the overall procedure between the buccal (92%) and the vaginal groups (95%) (chi(2)=1.87, p=.17). CONCLUSION: Buccal administration of misoprostol after low-dose mifepristone for medical abortion appears to be a highly effective and acceptable alternative compared with vaginal administration for medical abortion in pregnancies through 56 days LMP.     

Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy

This prospective, open-label, randomized trial of healthy adult women up to 9 weeks pregnant compared mifepristone 200 mg followed 2 days later with misoprostol 400 microg orally versus misoprostol 800 microg vaginally. The study was interrupted after the oral misoprostol group experienced a higher than expected failure rate. This treatment was discontinued and another substituted consisting of oral misoprostol 800 microg divided into two doses two hours apart. Women returned for a follow-up visit from Day 4 to 8. All women with a continuing pregnancy received a repeat dose of misoprostol vaginally and returned before Day 15. The primary outcome measure was a complete medical abortion without surgical intervention at the first visit. Of the 1045 women enrolled, 1011 had complete data: Group 1 (220) used oral misoprostol 400 microg, Group 2 (269) used oral misoprostol 800 microg, and Group 3 (522) used vaginal misoprostol 800 microg. At first follow-up visit, the primary outcome, that is, a complete abortion, was 84% for Group 1, 92% for Group 2, and 96% for Group 3, p < 0.001. After a second dose of vaginal misoprostol in women with on-going pregnancies at their first follow-up visit, the complete abortion rates were 91%, 95%, and 98%, respectively, p < 0.001. There were minimal differences in side effects, onset of bleeding and overall acceptability in the three groups. Mifepristone 200 mg followed by vaginal misoprostol 2 days later was more effective at inducing an abortion up to 9 weeks of pregnancy than the same dose of mifepristone followed by oral misoprostol.     

Two medical abortion regimens for late first-trimester termination of pregnancy: a prospective randomized trial

Background

Medical abortion regimens based on the use of either misoprostol alone or in association with mifepristone have shown high efficacy and excellent safety profile in early pregnancy abortion. However, no clear recommendation is available for late first-trimester termination of pregnancy.

Study Design

A prospective randomized controlled trial included 122 women seeking medical abortion at 9 to 12 weeks of gestation. Seventy-three patients were given a fixed protocol of 200 mg of mifepristone followed 48 h later by 400 mcg oral misoprostol (Group 1). The second group of 49 patients was administered 800-mcg intravaginal single-dose misoprostol (Group 2). This study sought to compare safety, efficacy and acceptability of these two nonsurgical abortion regimens.

Results

Fifty-nine (80.8%) women in Group 1 had complete abortion vs. 38 (77.4%) women in Group 2 (p=.66). Abdominal pain was observed significantly more often in Group 2 (35/49 (71.4%) vs. 32/73 (43.8%) in Group 1, p<.0001. Medical abortion was equally acceptable among the two groups [37/49 (75.5%) and 55/73 (75.7%), p=.89].

Conclusion

For late first-trimester termination, a single 800-mcg vaginal dose of misoprostol seems to be as effective as the mifepristone+misoprostol regimen, with acceptable side effects.