A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. A randomised study of misoprostol and gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial. Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy. Early abortion induction by a combination of mifepristone and oral misoprostol: a comparison between two dose regimens of misoprostol and their effect on blood pressure. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Induction of abortion in the second trimester by a combination of misoprostol and mifepristone: a randomized comparison between two misoprostol regimens. Randomized, double-blind, controlled trial of mifepristone in capsule versus tablet form followed by misoprostol for early medical abortion. Misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone: a randomised comparative trial. A comparison of 600 and 200 mg mifepristone prior to second trimester abortion with the prostaglandin misoprostol. A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Mifepristone 100 mg in abortion regimens. The abortifacient effect of misoprostol in the second trimester. A randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486). Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation. A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12-20 weeks gestation. Mifepristone in second-trimester medical abortion: a randomized controlled trial. The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol. Randomized trial of misoprostol and cervagem in combination with a reduced dose of mifepristone for induction of abortion. A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial. Vaginal vs. sublingual misoprostol with mifepristone for cervical priming in second-trimester abortion by dilation and evacuation: a randomized clinical trial. Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China. Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial. Are two doses of misoprostol after mifepristone for early abortion better than one? [Prevent from bleeding after medical abortion through prolonged application of mifepristone with misoprostol for terminating early pregnancy]. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. Two-pill regimens of misoprostol after mifepristone medical abortion through 63 days' gestational age: a randomized controlled trial of sublingual and oral misoprostol. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy. A prospective randomized study on the measured blood loss in medical termination of early pregnancy by three different misoprostol regimens after pretreatment with mifepristone. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study.
The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion.
                Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects.
                There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group.
                Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. To compare the effectiveness of gemeprost and misoprostol as prostaglandins used in combination with mifepristone for induction of mid-trimester termination.
                Randomised trial.
                Scottish teaching hospital.
                One hundred women undergoing abortion between 12 and 20 weeks.
                Each woman received 200 mg mifepristone and 36-48 hours later either 1 mg gemeprost vaginal pessary every 6 hours for 18 hours or 4 x 200 microg misoprostol tablets vaginally followed by 2 x 200 microg misoprostol tablets orally every 3 hours for 12 hours. Success was defined as the percentage of women aborted within 24 hours of the first administration of prostaglandin.
                Prostaglandin-abortion interval and side effects.
                There were no significant differences in median prostaglandin-abortion interval between gemeprost (6.6 hours 95% CI 6.0-10.7) and misoprostol (6.1 hours 95% CI 5.5-7.5) (P = 0.22). The cumulative abortion rates at 24 hours (96% vs 94%, respectively), the surgical evacuation rates (12% and 10%) and the incidence of vomiting, diarrhoea and pain were similar.
                Two hundred milligrammes of mifepristone followed 36-48 hours later by either vaginal gemeprost or misoprostol is a highly effective way of inducing abortion in the second trimester of pregnancy. To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation.
                Randomised controlled trial.
                Aberdeen Royal Infirmary.
                Women undergoing medical abortion under the terms of the 1967 Abortion Act.
                Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred.
                Women's acceptability, efficacy of the regimen and side effects experienced.
                A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01).
                Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration. Several studies have now reported the successful use of the sublingual administration of misoprostol for medical abortion in the first trimester. The objective of this study was to assess the acceptability to women, the efficacy of the regimen, as well as the acceptability to staff of sublingual versus vaginal administration of misoprostol following mifepristone for medical abortion at 13-20 weeks gestation.
                Women were randomized by opening consecutive sealed envelopes generated using random number tables. Mifepristone (200 mg) was followed 36-48 h later by sublingual administration of misoprostol 600 microg or vaginal misoprostol 800 microg. This was followed by 3 hourly doses of misoprostol 400 microg administered sublingually or vaginally.
                A total of 76 women were randomized. Of women in the sublingual group, 24 (66.7%) expressed satisfaction with the route of misoprostol administration compared with 25 (62.5%) in the vaginal group. A higher proportion in the sublingual group used intramuscular opiates. There was no significant difference in the surgical evacuation rate between the sublingual (three out of 36 women, 8.3%) and vaginal groups (one out of 40, 2.5%), (P=0.26) and acceptability to staff was the same for both methods.
                Sublingual administration of misoprostol following mifepristone is an acceptable and effective alternative to vaginal administration for medical abortion at 13-20 weeks gestation. However, women should be advised about the greater likelihood of requiring stronger analgesia. Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation.
                The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7+/-1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication.
                The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0-96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1-98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1.
                Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568
                I. A combination of mifepristone and misoprostol provides an effective method of medical abortion for early pregnancy. This is the first randomized trial comparing the use of sublingual misoprostol with vaginal misoprostol in combination with mifepristone for termination of early pregnancies up to 63 days.
                A total of 224 women who requested legal termination of pregnancy up to 63 days were randomized by computer- generated list into two groups and given 200 mg of oral mifepristone followed 48 h later by either 800 micro g of sublingual (n = 112) or vaginal (n = 112) misoprostol.
                Complete abortion occurred in 98.2% (95% CI: 93-99) of women in the sublingual group and 93.8% (95% CI: 88-97) in the vaginal group. There were three ongoing pregnancies in the vaginal group but none in the sublingual group. The median duration of vaginal bleeding was 17 days. There was no serious complication. Fever, chills and gastrointestinal side-effects (nausea, vomiting and diarrhoea) were significantly more common in the sublingual group.
                The combination of mifepristone and misoprostol is effective for medical abortion up to 63 days. Both the sublingual and vaginal are effective routes of administration. Further randomized trials are required to find out the optimal dose of sublingual misoprostol that can give the highest complete abortion rate and lowest incidence of side-effects. Medical termination of pregnancy can be successfully performed with a combination of mifepristone (RU 486) and a prostaglandin analogue. We conducted a prospective, randomized trial to compare oral with vaginal administration of the prostaglandin E1 analogue misoprostol for first-trimester abortion in women treated initially with mifepristone.
                The study population consisted of 270 women seeking abortion within 63 days after the onset of amenorrhea. The dose of mifepristone was 600 mg, and the dose of misoprostol was 800 micrograms. The study had two primary end points: expulsion of the conceptus without the need for a surgical procedure, and abortion within four hours after the administration of misoprostol.
                Expulsion of the conceptus without the need for a surgical procedure occurred in 95 percent of the women who received misoprostol vaginally and in 87 percent of those who received it orally (P = 0.03). The rate of continued pregnancy was 7 percent with the oral regimen and 1 percent with the vaginal regimen (P = 0.01). Ninety-three percent of the women receiving misoprostol vaginally had abortions within four hours, as compared with only 78 percent of the women receiving the drug orally (P < 0.001). Vomiting and diarrhea were reported more frequently by the women who received oral misoprostol than by those who received vaginal misoprostol (P = 0.04 and P = 0.002, respectively).
                After the administration of mifepristone, vaginal administration of misoprostol is more effective and better tolerated than oral administration for the induction of first-trimester abortion. To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion.
                Randomised nonblinded trial.
                Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area.
                Women of reproductive age.
                Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period.
                Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975).
                Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability.
                There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol. It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable. 1. To investigate the efficacy of 800 micrograms misoprostol (a PGE1 analogue) when administered to women pretreated with mifepristone for early pregnancy termination. 2. To establish means of minimising gastrointestinal side effects by comparing two different misoprostol regimens. The impact of these regimens on blood pressure was investigated in a subgroup of patients.
                A randomised study of 150 women of 56 days gestation, or less, allocated to receive oral misoprostol either in a single dose of 800 micrograms or as two doses of 400 micrograms administered sequentially 2 h apart; in each case misoprostol was administered 36 to 48 h after receiving mifepristone 200 mg orally.
                Complete abortion rates, the frequency and severity (patients' perception) of gastrointestinal side effects, and blood pressure changes in response to prostaglandin administration.
                The overall success rate was 93%. Seventy-one (95%) women who received a single dose of misoprostol and sixty-nine (92%) who received the sequential dose aborted completely. There were two ongoing pregnancies in the first group (2.5%) and three (4%) in the second. The overall ongoing pregnancy rate was 3%. The incidence of diarrhoea was significantly lower for women receiving the sequential dose, and no significant differences were found in the incidence of the other gastrointestinal side effects. The only noted significant change in blood pressure was in diastolic pressure 4 h after the administration of the higher dose of prostaglandin, but this was slight.
                The combination of mifepristone and oral misoprostol provides an alternative method to inducing abortion of pregnancies of up to eight weeks gestation. Patients receiving the single dose of 800 micrograms were more troubled by diarrhoea than those on the sequential regimen. The ongoing pregnancy rate was higher than previously reported with vaginal or parenteral administration of prostaglandin. 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. 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.
                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.
                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).
                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. To compare the efficacy of vaginal with oral misoprostol in termination of second-trimester pregnancy after pretreatment with mifepristone.
                Women requesting termination of second-trimester pregnancy were randomized into two groups. Thirty-six to 48 hours after oral administration of 200 mg of mifepristone, women were given either oral or vaginal misoprostol 200 microg every 3 hours for a maximum of five doses in the first 24 hours. Women receiving oral misoprostol also were given a vaginal placebo (vitamin B6), whereas those receiving vaginal misoprostol were given an oral placebo. If they failed to abort, a second course was given by the same route.
                The median induction-abortion interval in the vaginal group (9 hours) was significantly shorter than that in the oral group (13 hours). The percentage of women aborting within 24 hours in the vaginal group (90%) was significantly higher than that in the oral group (69%). The median amount of misoprostol used in the vaginal group (600 microg) also was significantly less than that in the oral group (1000 microg). There was no significant difference in the incidence of side effects between the two groups except for fatigue and breast tenderness, which were more common in the oral group. Seventy-six percent of the women preferred the oral route, and 24.5% of the women preferred the vaginal route.
                Vaginal misoprostol is more effective than oral misoprostol in termination of second-trimester pregnancy after pretreatment with mifepristone, but more women preferred the oral route. The combination of mifepristone (RU486) and prostaglandin is effective in the induction of abortion in the second trimester. The optimal regimen is still under development, but is likely to be characterized by a short induction-to-abortion interval, low incidence of side-effects and high acceptability. We have investigated further whether misoprostol, a synthetic prostaglandin E1 analogue, can reliably induce second trimester abortion in 70 women pre-treated with mifepristone, and whether different routes of administration affect the induction-to-abortion interval. Abortion was achieved in 97% [95% confidence interval (CI) 90-100%] of cases without resort to other prostaglandin agents. The mean induction abortion time for the studied population was 6.4 h (95% CI 5.6-7.0 h). No significant difference was found between two different routes of administration, namely vaginal versus a combination of vaginal and oral. Misoprostol has a number of advantages over other prostaglandin preparations. We recommend that, following pre-treatment with mifepristone, misoprostol is used as the prostaglandin of choice to induce abortion in the second trimester. To compare the efficacy and side-effects of mifepristone 75 mg in capsule form versus 150 mg in tablet form followed by misoprostol for medical termination of early pregnancy.
                In a prospective randomized, double-blind, placebo-controlled trial, a total of 480 women who were 49 days or less pregnant were randomized by means of a random number table to receive either two tablets in the morning and one tablet 12 h later for 2 days (group A) or three capsules orally twice daily for 2 days, the first dose being double all subsequent doses (group B). After a further 48 h, 600 microg misoprostol was given orally. Successful abortion was defined as complete abortion with no need for surgical aspiration.
                There were no significant differences between the two study groups in the rates of complete abortion (95.4% in group A versus 96.3% in group B), incomplete abortion (3.8% in group A, 3.3% in group B) and continued pregnancy (0.8% in group A, 0.4% in group B). No significant difference in the duration and amount of vaginal bleeding was observed. The incidence of side-effects, such as vomiting, nausea, headache, diarrhea and lower abdominal pain was similar in the two groups.
                Our results indicate that 75 mg mifepristone in capsule form combined with 600 microg misoprostol is as effective and safe as 150 mg mifepristone in tablet form for the termination of pregnancy up to 49 days. A prospective randomized study was conducted to compare the efficacy of misoprostol with gemeprost when combined with mifepristone for termination of second trimester pregnancy. Patients requesting termination of second trimester pregnancy were randomized into two groups. In both groups of patients, 200 mg of mifepristone was given 36 to 48 hours before the administration of prostaglandins. In Group 1, the women were given 400 micrograms of oral misoprostol every 3 hours up to 5 doses. In Group 2, patients were given 1 mg of vaginal gemeprost every 6 hours up to 4 doses. The main outcomes measured were the induction-abortion intervals (the interval between the first dose of prostaglandin and abortion) and the incidence of side effects. Altogether, 50 subjects were recruited with 25 women in each group. The mean age and parity of the women and the mean gestational age of the two groups of women were comparable. There was no significant difference in the median induction-abortion intervals (8.7 hours in Group 1 and 10.8 hours in Group 2) or the incidence of side effects between the two groups of patients. We conclude that misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone. To compare the use of 600 and 200 mg mifepristone prior to second trimester termination of pregnancy with the prostaglandin misoprostol.
                A randomised study.
                A Scottish teaching hospital.
                Seventy women undergoing legal induced abortion between 13 and 20 weeks of gestation.
                Administration of either 600 or 200 mg mifepristone 36 to 48 hours prior to prostaglandin.
                Induction-abortion interval.
                The geometric mean induction abortion interval was 6.9 (95% CI 5.8-8.4) h and 6.9 (95% CI 5.8-8.2) h in the 600 and 200 mg groups, respectively (no significant difference). The median dose of misoprostol was 1600 micrograms (three doses) in each group. Analgesic requirements and prostaglandin-related side effects were similar between groups. Overall, 11.4% of women required surgical evacuation of the uterus as a result of retained placenta.
                The dose of mifepristone used in second trimester abortion can be reduced from 600 to 200 mg. To demonstrate equivalence between mifepristone 200 mg followed 6 to 8 hours later and 24 hours later by misoprostol 800 microg vaginally for abortion in women up to 63 days of gestation.
                Mifepristone 200 mg was swallowed by 1,080 women after which they were randomly assigned to self-administer misoprostol intravaginally 6 to 8 hours later (group 1) or 23 to 25 hours later (group 2) at home. Participants returned for an evaluation, including transvaginal ultrasonography, 7 +/- 1 days after initiating treatment. Subjects who had not aborted were offered a second dose of misoprostol. All participants returned approximately 2 weeks after receiving mifepristone. Telephone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication.
                Complete abortion rates for groups 1 and 2 were 503 of 525 (95.8%, 95% confidence interval 93.7%, 97.3%) and 521 of 531 (98.1%, 95% confidence interval 96.6%, 99.1%), respectively, which were statistically equivalent. Side effects were significantly more common after mifepristone administration for women in group 2. Nausea, vomiting, and heavy bleeding were also significantly greater for women in group 2 after misoprostol treatment. Pain and subject acceptability were similar between groups.
                Mifepristone 200 mg followed 6 to 8 hours later by misoprostol 800 microg vaginally is as effective for abortion and has significantly fewer side effects as compared with regimens using a 24-hour dosing interval. Women receiving mifepristone and vaginal misoprostol for abortion can have the flexibility to administer the misoprostol as soon as 6 hours after using the mifepristone. To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 microg orally or 800 microg vaginally in women at up to 49 days' gestation.
                Eighty participants received mifepristone 100 mg and then were randomized to misoprostol, administered 48 hours later, at a dose of 400 microg orally (group 1) or 800 microg vaginally (group 2). Women returned for follow-up evaluations 24 +/- 1 hour after using the misoprostol and then 2-3 weeks later. If abortion still had not occurred and the pregnancy was nonviable, the subject returned again after an additional 3 weeks.
                Twenty-four hours after receiving misoprostol, 34 (85%; 95% confidence interval [CI] 71%, 94%) of the 40 women in group 1 and 38 (95%; 95% CI 85%, 99%) of the 40 women in group 2 had complete abortions. Overall, complete abortion without surgical intervention occurred in 34 women in group 1 (85%; 95% CI 71%, 94%) and 40 women in group 2 (100%; 95% CI 91%, 100%; P =.03). Four women in group 1 required suction aspiration for continuing pregnancy at the second follow-up, compared with none in group 2 (P =.12). Side effects occurred with similar frequency in both treatment groups.
                Low-dose mifepristone (100 mg) combined with vaginal misoprostol 800 microg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol. The objective of this work was to study the abortifacient effects of misoprostol, an orally active prostaglandin E1 (PGE1) analogue, in the second trimester. A randomized study of two prostaglandin regimens in women pre-treated with the antiprogesterone mifepristone was carried out in the gynaecological wards of Aberdeen Royal Hospitals, NHS Trust, and included 60 women at 13-20 weeks' gestation, in whom termination of pregnancy had been agreed. Following pre-treatment with mifepristone 600 mg women were randomly allocated to one of two prostaglandin regimens which started 36-48 h later. The first misoprostol 400 micrograms orally (up to three doses) followed by gemeprost vaginal pessary 1 mg up to two doses. The second was gemeprost vaginal pessary 1 mg up to five doses. The main outcome measures were success rate induction-to-abortion interval and side-effects. There were no significant differences between the two groups in any of the main outcome measures. We conclude that misoprostol is a stable, cheap PGE1 analogue with demonstrable efficacy and acceptable side-effects in the management of second trimester abortion. Further work is needed to establish the optimum dose and regimen. Gemeprost and misoprostol are two of the most widely used prostaglandins in combination with mifepristone for medical abortion in early pregnancy. However, the efficacy and side-effects of those two drugs given vaginally have not been assessed in a randomized trial.
                Randomized double-blind controlled trial involving 999 women undergoing an abortion at gestational age < or =63 days who received either 0.5 mg gemeprost (group I, n = 499) or 800 microg misoprostol (group II, n = 500) vaginally approximately 48 h after taking 200 mg mifepristone by mouth. The rate of complete abortion and the side-effects were compared between the groups.
                A total of 89 cases was excluded from full analysis of outcome because either they aborted after mifepristone alone (n = 2), had an ectopic pregnancy (n = 1), or because the outcome was uncertain as they failed to attend their follow-up appointment (n = 86). The rate of complete abortion was very high (>95%) in both groups but significantly higher after treatment with misoprostol than with gemeprost [436/453 (98.7%) versus 451/457 (96.2%), P = 0.019, difference 2.5%, confidence interval 0.4-4.7%] and there were fewer ongoing pregnancies (n = 1 versus n = 8, P < 0.018). Surgical intervention rose significantly with gestation in women who received gemeprost (P < 0.03) but not with misoprostol. The incidence of side-effects such as diarrhoea (13.7 versus 16.4%) and vomiting (27.8 versus 29.7%) was similar in women who received misoprostol or gemeprost respectively, as was the duration and amount of bleeding.
                (i) Both regimens using a reduced dose of mifepristone are highly effective methods of inducing abortion in early pregnancy; (ii) vaginal misoprostol is the preferred prostaglandin because it is it is associated with fewer failures than low-dose gemeprost, particularly at gestation > or =49 days. Sublingual misoprostol has been shown to be effective in medical abortion. A prospective double-blinded placebo-controlled trial was done to compare the efficacy and side-effects of sublingual to oral misoprostol when used with mifepristone for medical abortion from 12 to 20 weeks gestation.
                A total of 120 women at 12-20 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either sublingual or oral misoprostol 400 mg every 3 h for a maximum of five doses 36-48 h later. The course of misoprostol was repeated if the woman did not abort within 24 h.
                There was no significant difference (P = 0.43) in the success rate at 24 h [relative risk = 1.075; 95% confidence interval (CI): 0.94-1.19]. Abortion occurred in 91.4% in the sublingual group (95% CI: 81.0-96.7%) as compared to 85.0% (95% CI: 73.7-92.1%) in the oral group. The median induction-to-abortion interval was significantly shorter (P = 0.009) in the sublingual group (5.5 h) as compared to the oral group (7.5 h). The incidence of fever was higher in the sublingual group (P < 0.0001). The incidences of other side-effects were similar.
                Sublingual misoprostol, when combined with mifepristone, is effective for medical abortion in the second trimester. The induction-to-abortion interval is shorter when sublingual misoprostol is used when compared to oral misoprostol. To investigate the adjunctive use of mifepristone in second-trimester induction abortions using misoprostol 1 day after feticidal digoxin.
                This is a randomized, placebo-controlled, double-blind trial of mifepristone in second-trimester induction termination using misoprostol after feticidal digoxin. Women seeking abortion between 18 and 23 weeks of gestation were offered enrollment. At the time of digoxin amnioinfusion, participants received a randomly allocated, identical-appearing capsule containing either mifepristone, 200 mg, or placebo. Patients returned the following day for induction with buccal misoprostol. The primary outcome was the time interval from the first misoprostol dose to abortion. Analysis utilized survival curves with log-rank testing.
                Of 64 women, 32 received mifepristone and 32 received placebo. The groups did not differ by ethnicity, age, parity, reason for termination, or gestational age. Median procedure time was significantly shorter for those who received mifepristone, 10 hours (95% confidence interval [CI] 8-12), than those who did not, 18 hours (95% CI 15-22), P<.01, and those parous, 10 hours (95% CI 9-14), compared with nulliparous, 16 hours (95% CI 12-22, P=.02). Other findings in the mifepristone compared with placebo group included rates of placental retention, 3.1% compared with 6.3% (P=.61), length of hospitalization, 0.66 days compared with 0.8 days (P=.23), and analgesic requirements, 27.2 mg compared with 39.3 mg morphine (P=.22). Side effects during induction were similar between groups.
                Addition of mifepristone in second-trimester termination inductions using misoprostol significantly reduces the abortion time interval.
                Clinicaltrials.gov, www.clinicaltrials.gov, NCT00382538
                I. Although it has been demonstrated that a combination of mifepristone and a prostaglandin is an effective method of inducing abortion in early pregnancy, the optimum dose of the antigestogen is unknown. Women (n = 220) requesting abortion in early pregnancy (< or = 63 days amenorrhoea) were randomized to receive a single dose of either 600 or 200 mg mifepristone followed 48 h later by a single dose of 600 micrograms misoprostol by mouth. The percentage of women who had a complete abortion (93.6% confidence interval 90.4-95.5%) was identical in the two groups. There was no significant difference in the number of women who passed the fetus within 4 h of receiving the prostaglandin (64 versus 74%), the days of bleeding (14.6 +/- 1.1 versus 15.3 +/- 0.9) nor in the onset of the next period (39.7 +/- 1.3 versus 36.7 +/- 1.3) respectively between the groups receiving 200 or 600 mg mifepristone. However, the complete abortion rate was significantly higher in women < or = 49 days compared to women 50-63 days amenorrhoea (97.5 versus 89.1% respectively; P < 0.02). There was no difference in any of the other parameters at different weeks of gestation. We conclude: (i) that the recommended dose of mifepristone could be reduced from 600 to 200 mg without loss of clinical efficacy, (ii) that the combination of mifepristone and 600 micrograms misoprostol is a highly effective alternative to vacuum aspiration for inducing abortion in women < 50 days amenorrhoea and (iii) at gestation > 56 days, this combination may result in too many incomplete abortions to be clinically acceptable. Mifepristone (600 mg) in combination with a prostaglandin has been demonstrated to be a safe, acceptable alternative to vacuum aspiration for induction of abortion in the first 9 weeks of pregnancy. However, the efficacy and side-effects of different prostaglandins used in combination with mifepristone have not been assessed in a randomized trial. In this study, 800 women seeking an abortion at gestational age < or = 63 days amenorrhoea were randomized to receive either 0.5 mg gemeprost by vaginal pessary (group I) or 600 micrograms misoprostol (group II) by mouth approximately 48 h after taking 200 mg mifepristone by mouth. The side-effects and number of complete abortions were used as measures of efficacy. There was no significant difference in the rate of complete abortion between group I [96.7%; 95% confidence interval (CI) 94.9-98.5%, n = 391] and group II (94.6%; 95% CI 92.3-96.9, n = 386). It was not possible to assess the outcome with certainty in the remaining 23 women. However, there were significantly more ongoing pregnancies in the women who received misoprostol than in those who received gemeprost (nine versus one, P < 0.01) and in eight of these 10 women the gestation was > 49 days. Fewer women in group II required analgesia than in group I (48 versus 60%, P < 0.001) although the number requesting opiate was similar in each group (6.9 versus 5.2%, P > 0.4). The incidence of nausea and vomiting after misoprostol (47.8 and 21.9% respectively) was higher (P < 0.001) than after gemeprost (33.9 and 12% respectively).(ABSTRACT TRUNCATED AT 250 WORDS) Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy.
                250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration.
                Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05).
                A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available. To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion.
                Double-blind, randomised controlled trial.
                Fifteen gynaecological clinics in 11 countries.
                A total of 2219 healthy pregnant women requesting medical abortion with < or =63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method.
                Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment.
                The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method.
                The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know.
                The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home. To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy.
                Placebo-controlled, randomized, equivalence trial, stratified by centre.
                13 departments of obstetrics and gynecology in nine countries.
                2,181 women with 63 days or less gestation requesting medical abortion.
                Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions.
                Rates of complete abortion without surgical intervention and adverse effects associated with the regimens.
                Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups.
                Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol. The study was conducted to assess the effectiveness of mifepristone 200 mg 48 h before administering misoprostol 600 mug, sublingual vs. vaginal route, prior to dilation and evacuation (D&E) in 12- to 20-week pregnancies.
                Randomized clinical trial.
                Clínica Mediterrania Médica, Valencia, Spain.
                Women with 12- to 20-week pregnancies wanting a voluntary abortion between July 9, 2004, and February 9, 2006.
                Nine hundred women were randomized to be included in one of the following four groups: (I) mifepristone 200 mg plus sublingual misoprostol 600 microg before D&E, (II) mifepristone 200 mg plus vaginal misoprostol 600 microg before D&E, (III) sublingual misoprostol 600 microg before D&E and (IV) vaginal misoprostol 600 microg before D&E.
                The degree of cervical dilation achieved before D&E, surgical time necessary to terminate the pregnancy and side effects of misoprostol.
                The average cervical dilation in the mifepristone groups was 12.5+/-2.8 mm (SD) [95% confidence interval (CI), 12.3-12.8] vs. 8.5+/-3.2 mm (SD) (95% CI, 8.2-8.8) in those receiving only misoprostol. Surgical time in the mifepristone sublingual misoprostol group was 11.9+/-4.3 min (SD) vs. 13.0+/-5.3 min (SD) in the sublingual misoprostol group without mifepristone (p=.007); in the mifepristone vaginal misoprostol group, the average surgical time was 12.3+/-5.0 min (SD) vs. 13.0+/-6.2 (SD) in the vaginal misoprostol group without mifepristone (p=.031).
                Administering mifepristone before D&E with misoprostol in second-trimester abortions makes surgery easier and shorter and, to a certain extent, lessens the risk of cervical injuries, especially in D&E in advanced gestational periods. A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost. To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400 microg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days.
                Prospective, randomised trial.
                Clinical research office.
                Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of < or = 49 days.
                After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation 24 +/- 1 hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks.
                Rate of complete abortion 24 hours after administration of misoprostol.
                At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group I and 40/44 (91%, 95% CI 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively.
                After treatment with mifepristone 600 mg, administration of misoprostol 400 microg orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications. OBJECTIVE: The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy. DESIGN: Randomised, placebo controlled trial. SETTING: K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India. SAMPLE: A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method. To find out the optimal doses regimen of mifepristone with misoprostol for termination early pregnancy.
                A randomized comparative study in 1,621 women requesting medical abortion at < or = 49 days from 9 hospitals was conducted in Hebei, women were randomly divided into 2 groups by 2:1 ratio. Study group (n = 1,118) women took mifepristone 50 mg immediately, then 25 mg b. i. d(total amount of 300 mg), plus misoprostol 600 micrograms at 8:00 in the morning on 3th day, and plus misoprostol 200 micrograms respectively at 8:00 in the morning on 4th, 5th, 6th day. In control group (n = 494), mifepristone 50 mg immediately, then, 25 mg b. i. d (total amount of 150 mg), plus misoprostol 600 micrograms at 8:00 in the morning on 3th day.
                In study group and control group, the complete abortion rate was 98.39% and 88.06% respectively, bleeding duration was (8.2 +/- 2.8) days and (12.3 +/- 3.9) days. There was no difference of side effects between the two groups.
                Mifepristone taken 300 mg plus misoprostol 1,200 micrograms orally for 6 days is an optimal dose regimen for termination of early pregnancy. To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of < or = 35 days.
                Double-blind, randomised controlled trial.
                Seventeen centres internationally.
                We enrolled 1,589 healthy pregnant women with menstrual delay of < or = 35 days who were requesting nonsurgical abortion.
                Within gestational age strata, we randomly assigned women to receive a single oral dose of mifepristone, either 200 mg or 600 mg, followed in 48 h by misoprostol 400 microg by mouth. We concealed the allocation assignments from investigators and participants and maintained double-blinding throughout the study.
                Complete abortion was the principal outcome measure. We also compared rates of side effects such as abdominal pain.
                The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (89.3% vs 88.1%) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 (95% CI 0.7 to 1.2). The likelihood of complete abortion was inversely related to gestational age, although this finding is exploratory in nature. Among failures the percentage of women with continuing pregnancies increased from 1.4% at menstrual delay of two weeks or less to 9.0% when the delay was 4-5 weeks. Low efficacy led to stopping enrolment at 29 to 35 days' menstrual delay. Stopping criteria were also met at completion of the study in the group with 22-28 days' menstrual delay. No significant differences emerged in the frequency of side effects between the two mifepristone groups.
                Both regimens had similar efficacy. Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses. The efficacy of the mifepristone-prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg. The regimens of 600 mg or 200 mg of mifepristone, followed by a single oral dose of misoprostol 400 microg 48 hours later, were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days. 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.
                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.
                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.
                The sublingual route appears superior to the regimen of 400 mcg misoprostol used orally and may be a good option for mifepristone medical abortion. To compare the efficacy of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate whether the efficacy can be improved and the duration of bleeding shortened by continuing oral misoprostol for one week.
                Double blind, randomised controlled trial.
                Fifteen gynaecological clinics in 11 countries.
                A total of 2219 healthy pregnant women requesting medical abortion with < or =63 days of amenorrhoea.
                Mifepristone 200 mg administered orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group and one of the vaginal groups continued with 0.4 mg of oral misoprostol twice daily for seven days.
                Complete abortion was the main outcome. Secondary outcomes were side effects, timing of expulsion and duration of bleeding.
                The crude complete abortion rate was 92.3% in the oral plus continued oral misoprostol group, in the vaginal-only group it was 93.5%, and it was 94.7% in the vaginal group that continued with oral misoprostol, when considering undetermined cases as failures. Among women with amenorrhoea length > or =57 days, the risk of failure of complete abortion was almost three times higher in the oral plus continued oral misoprostol group (RR = 2.8, 95% CI 1.3 to 5.8), and over two times higher in the vaginal-only group (RR = 2.2, 95% CI 1.0 to 4.7), when compared with the vaginal plus continued oral misoprostol group. Among women with amenorrhoea length < 57 days, the differences were not significant. Timing of expulsions and duration of bleeding were similar in the three groups.
                For amenorrhoea length > or =57 days, vaginal misoprostol is more effective than oral when continued with 0.4 mg oral misoprostol twice daily for seven days. Misoprostol continuation improved the efficacy in this amenorrhoea group compared with a single dose of vaginal misoprostol on day three, but it did not shorten the duration of bleeding. No differences in efficacy were observed when amenorrhoea length was < 57 days. Prolonged vaginal bleeding is a common complaint after medical abortion. The effect of a 1 week course of daily oral misoprostol after medical abortion with mifepristone and misoprostol on the amount of post-abortal blood loss was studied.
                A total of 150 women (gestation <or=63 days) were randomized to three groups using computer-generated tables. They received 200 mg oral mifepristone, followed 48 h later by 0.8 mg oral misoprostol and vaginal placebo in group A, and 0.8 mg vaginal misoprostol and oral placebo in groups B and C. In groups A and B, the women continued with oral misoprostol 0.4 mg twice daily on days 4-10, while the women in group C took placebo. The actual blood loss was measured by the alkaline haematin method.
                No significant difference in the median amount (82.8, 94.7 and 88.5 ml for A, B and C respectively) and duration (16, 15 and 16 days respectively) of vaginal bleeding was observed. The incidence of diarrhoea was significantly higher (66, 55.1 and 12.5% respectively) in the groups with oral misoprostol after abortion.
                A 1 week course of oral misoprostol (0.4 mg twice daily) could not decrease the duration and amount of vaginal bleeding. Further studies with a larger sample size are needed to assess whether the complete abortion rate can be improved with this regimen. This study was undertaken to compare the effectiveness of mifepristone orally administered at 24 or 48 hours before first-trimester vacuum aspiration abortion with that of vaginally administered misoprostol as a cervical priming agent.
                In a randomized comparative trial 90 women who requested surgical termination of pregnancy were randomly assigned to receive 200 mg mifepristone orally 24 or 48 hours before the operation or 800 microg misoprostol vaginally 2 to 4 hours before the operation. The main outcome measures were baseline cervical dilatation, cumulative force required to dilate the cervix to 9 mm, and intraoperative blood loss.
                The baseline cervical dilatation was significantly greater among women who received mifepristone 48 hours before the operation (P =.02). This group also required the least mechanical force to dilate the cervix (P =.06). There were no significant differences among the 3 groups in the intraoperative blood loss, in the operating time, or in patient acceptability. Side effects such as hot flushes and headaches were significantly higher among women who received mifepristone 24 or 48 hours before the operation than among those who received misoprostol (P =.01 and P =. 002, respectively).
                Mifepristone is an effective cervical priming agent when orally administered 48 hours before vacuum aspiration for termination of first-trimester pregnancy. Because of its cost and availability in comparison with misoprostol, however, selective use may have to be considered.
Medical abortion in the second trimester using the combination of mifepristone and misoprostol appeared to have the highest efficacy and shortest abortion time interval. Where mifepristone is not available, misoprostol alone is a reasonable alternative. The optimal route for administering misoprostol is vaginally, preferably using tablets at 3-hourly intervals. Apart from pain, the side-effects of vaginal misoprostol are usually mild and self limiting. Conclusions from this review are limited by the gestational age ranges and variable medical regimens, including dosing, administrative routes and intervals of medication, of the included trials.