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 mu g 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. (c) 2005 Elsevier Inc. All rights reserved.

OBJECTIVE: To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 &mgr;g oral misoprostol METHODS: The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 &mgr;g misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study RESULTS: Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory CONCLUSION: A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 &mgr;g oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration. LEVEL OF EVIDENCE: III

BackgroundThe Ipas™ double-valve manual vacuum aspiration (MVA) syringe is an alternative to electrical vacuum aspiration.MethodsThis study determines which US cannulae (flexible, rigid-straight and rigid-curved) work with the Ipas MVA syringe. Cannulae from Ipas, MedGyn™, Berkeley™ and Milex™, in sizes 6–12 mm, were randomized and affixed to the MVA syringe. A pressure gauge was attached to the cannula with rubber tubing. Pressure readings were recorded initially and over 30 s.ResultsMilex cannulae were not compatible. For the remaining brands, initial vacuum pressures ranged from 55 to 65 mmHg. Flexible cannulae from Ipas, Berkeley and MedGyn maintained initial pressures without leaks, as did the 6–12-mm straight- and curved-rigid cannulae by Berkeley. Eight of the 13 tested MedGyn rigid cannulae lost >10% pressure over 30 s.ConclusionSeveral US manufacturers produce cannulae that fit on the Ipas MVA syringe without a leak, including Ipas flexible cannula; Berkeley flexible, rigid-straight and rigid-curve cannulae and MedGyn flexible cannula, but not their rigid cannulae.

The objective of the study was to determine the effectiveness of a 6-mm coated cannula with Slip-Coat lubrication to avoid mechanical dilatation for abortion up to 712 weeks gestation. A blinded, randomized control trial of 50 healthy women, > or =18 years old, up to 54 days pregnant by ultrasound, requesting a surgical abortion was conducted. A successful outcome was defined as a completed abortion without the need for mechanical cervical dilatation. Of the 50 women, 29 received a Slip-Coat cannula, and 21 received a standard cannula. There were no overall differences in efficacy of the Slip-Coat cannula (17/29 or 59%) compared with the control group (12/21 or 57%, p = 0.91), or the acceptability of the procedure (93% versus 91%, respectively, p = 0.74), the level of pain (48 vs. 35, respectively, p = 0.052), acceptability of pain (66% vs. 67%, respectively, p = 0.93), or acceptability of bleeding (90% vs. 86%, respectively, p = 0.67). It was concluded that Slip-Coat cannulae were more effective than standard control cannulae for women who had no prior live births (6/10 or 60% vs. 0/7 or 0%, respectively, p = 0.01). This finding warrants further study.

Mifepristone was approved in September 2000 as the first medical abortifacient in the US for up to 7 weeks of pregnancy. Approximately 1.4 million abortions occur each year [1], and almost half are eligible (less than 8 weeks gestation) for a medical abortion [2]. Medical abortion has the potential to offer many US women an earlier abortion option than surgical abortion.

Previous studies of medical abortion with mifepristone and a prostaglandin have reported percentages of subjects who experience cramping and/or bleeding relative to prostaglandin use. This is the first analysis of cramping and bleeding onset patterns in subjects treated with low-dose (200 mg) mifepristone and 800 microg vaginal misoprostol at 24, 48, or 72 h after mifepristone. We analyzed the cramping and bleeding onset patterns in subjects up to 8 weeks pregnant who used 800 microg vaginal misoprostol at 24, 48, or 72 h after 200 mg of oral mifepristone. We collected data from subjects' symptom diaries and divided symptom onset into 3 categories: before misoprostol use, 0--12 h following misoprostol, and more than 12 h after misoprostol. Of the 2,302 subjects, cramping and bleeding onset data were available for 2,030 (88%) and 2,123 (92%), respectively. Across all groups, 230 (11%) experienced cramping and 445 (21%) experienced bleeding before misoprostol use. There was a significantly higher percentage of subjects who experienced early cramping and/or early bleeding between the three treatment groups, and this was related to the interval between mifepristone and misoprostol. In the 12 h following misoprostol administration, cramping and bleeding patterns were similar in the three groups. The longer subjects waited to insert misoprostol, the more likely they were to experience early cramping and/or bleeding. After misoprostol insertion, cramping and bleeding patterns are similar regardless of treatment group. Patients and providers cannot rely on symptom onset to predict treatment success.

The objective of this study was to identify predictors of narcotic analgesic use during medical abortion. Two-thousand-seven-hundred-forty-seven women with pregnancies of 63 days gestational age or less received 200 mg mifepristone followed by at-home use of 800 μg vaginal misoprostol in two consecutive clinical trials in the United States, and also reported their use of analgesics. Overall, 79% of these subjects used narcotic analgesics. Women in the 2nd of the two studies were randomized to use misoprostol 24, 48, or 72 h after mifepristone. Those who were randomized to 24 h were more likely to use narcotic analgesics than those who were randomized to 48 or 72 h. In both studies, the use of narcotic analgesia during medical abortion was less prevalent among parous women and Asian women, and among those with a gestational age of 56 days or less. The clinic providing care for the patient was the most important determinant of narcotic analgesia use, even though the analgesia was used at home. Use of narcotic analgesics in these women undergoing medical abortion at home was more prevalent than use reported in previous studies where women underwent medical abortion in a clinical setting.