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Objective: Our objective was to compare the sublingual administration and the vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion., Design: We used an open, multicenter, randomized trial., Locations: We conducted the study in four clinics (in Valencia, Castelló, Murcia and Murcia Capital) in Spain., Participants: A total of 1424 healthy pregnant women with amenorrhea of

The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec), self-administered into the vagina for medical abortion, in adolescents under 18 years ofage. A group of 150 adolescents with gestations between 63 and 84 days, with previous written consent from the patient and parents or guardians, received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 126/150 (84.0%, 95% confidence interval 77-89) patients. The frequencies of nausea and vomiting were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 13.2 +/- 3.8 days (median 13 days, range 1-22 days). The mean expulsion time was 8.0 +/- 3.4 h (median 8 h, range 1-14 h) for all subjects who aborted after the first misoprostol dose. The mean drop in hemoglobin was statistically significant (p = 0.001), but without clinical relevance. From the high abortion rate obtained, we concluded that misoprostol alone is a valid method for terminating unwanted pregnancies at 10-13 weeks' gestation in adolescents under 18 years of age in the absence of mifepristone.

The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec) self-administered into the vagina for medical abortion in adolescents under the age of 18 years. After obtaining written consent from the patients and parents or guardians, a group of 150 adolescents with gestations between 35 and 63 days received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 133/150 (88.7%, 95% confidence interval 82-93) patients. The frequencies of nausea, vomiting and diarrhea were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 12.7 +/- 5.7 days (median 12 days, range 1-23 days). The mean expulsion time was 6.8 +/- 2.4 h (median 6 h, range 3-14 h) for those who aborted after the first misoprostol dose. The mean time for the return of menses, for those who aborted with misoprostol, was 34.7 +/- 3.4 days. The mean decrease in hemoglobin was statistically significant (p = 0.001), but had no clinical relevance. Taking into account the high abortion rate obtained, we could conclude that misoprostol alone is a valid method for terminating unwanted pregnancies in adolescents under the age of 18 years.

The objective of this study was to evaluate the efficacy and safety of the vaginal self-administration of 600 microg misoprostol up to a maximum administration of three doses in a 24-h period, one every 8 h, for abortion up to 9 weeks' gestation. A group of 90 voluntary women with gestations from 35 to 63 days participated in the study. All women who aborted received a single additional dose of 600 microg misoprostol. Outcome measures included successful abortion (complete abortion without requiring surgical procedure) and side-effects. Complete abortion occurred in 57/89 (64%, 95% confidence interval 53-74%) subjects. The mean expulsion time was 7.4 +/- 3.8 h (median 7.2 h, range 3-20 h) for all women who aborted within the first 24 h of the administration of misoprostol. Thirty-two cases failed to abort, 28 cases due to failure of the method, of which 24 had a negative cardiac rhythm after the third dose, and four cases due to the doctor's decision. The results obtained in this study led us to the conclusion that the 600-microg misoprostol dose regimen was not adequate to produce a high or an acceptable abortive efficacy.

The objective of this study was to confirm the effectiveness and safety of self-administration of misoprostol every 24 h, for abortion up to 9 weeks of gestation. A group of 720 volunteer subjects with gestations from 35 to 63 days received 800 micrograms of vaginal misoprostol every 24 h up to a maximum of three main doses for abortion. Outcome measures assessed included successful abortion (complete abortion without requiring surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, and mean time of return of menses. Complete abortion occurred in 644 of 720 (89.4%, 95% CI 87, 92) subjects. The mean decrease in hemoglobin was statistically significant (p = 0.0001). There were 14 subjects with clinically significant decreases in hemoglobin, but only two required transfusions. Vaginal bleeding lasted 6.7 +/- 3.9 days, spotting 8.1 +/- 4 days, and total bleeding 14 +/- 5.3 days. Mean expulsion time was 8.0 +/- 3.4 h. Although mifepristone remains unavailable, given the low price and availability of misoprostol in > 72 countries of the world, this latter drug constitutes an abortion alternative, provided that a minimum clinical network is nearby or accessible.

Objective: The effectiveness and safety of misoprostol have been reported for abortion up to 22 weeks' gestation. The objective of this study was to demonstrate the effectiveness and safety of self-administration of misoprostol every 12 h, without the need of postexpulsion systematic curettage, in late first-trimester abortions (10-13 weeks' gestation)., Methods: A group of 180 women with gestations from 64 to 91 days, self-administered 800 micrograms of vaginal misoprostol every 12 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete and incomplete abortion without requiring a surgical procedure), side-effects, mean expulsion time and vaginal bleeding., Results: Successful abortion occurred in 153/180 (85%) subjects (95% confidence interval (CI) 79-90). The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.1 mg/dl (SD 1.1) before treatment and 11.7 mg/dl (SD 1.1) afterwards. The mean expulsion time for patients who aborted after the first dose was 8.3 +/- 3.6 h (median 8 h, range 2-12 h). Vaginal bleeding lasted 6 +/- 3 days, spotting 7 +/- 3 days and total bleeding 13 +/- 4 days. The median dose of misoprostol administered was 1780 micrograms (range 1400-3000 micrograms)., Conclusions: The high degree of acceptability, its efficacy and the fact that postabortion systematic curettage was not needed make misoprostol a suitable alternative to the currently available methods for termination of pregnancy at 10-13 weeks' gestation.

A prospective multicenter, randomized trial was performed to evaluate if moistened misoprostol results in a more rapid abortion and a higher rate of complete abortion compared with dry misoprostol when administered intravaginally for medical abortion after methotrexate. A total of 240 pregnant women < or = 49 days gestation seeking elective abortion received 50 mg/m2 methotrexate intramuscularly followed 5-6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated in 1-2 days if the abortion did not occur. Group 1 moistened the misoprostol before administration and group 2 used dry tablets. There was no statistically significant difference in the cumulative rate of abortion after the first misoprostol dose (73.0% vs 71.3%, p = 0.87), second misoprostol dose (84.1% vs 81.1%, p = 0.65), or by 35 days after methotrexate administration (95.2% vs 91.8%, p = 0.40) between groups 1 and 2, respectively. The proportion of subjects with embryonic cardiac activity 2 weeks after methotrexate injection was greater in group 2 (5.7%, 95% confidence interval [CI] 1.0%, 9.9%) than in group 1 (2.4%, 95% CI 0%, 5.0%), although not statistically significant (p = 0.21). The immediate success rate in Pittsburgh was greater, albeit not statistically, for the women that moistened the misoprostol (87% vs 76%, p = 0.19); these rates were also not statistically different in Havana (82% vs 86%, p = 0.62). The rate of side effects after methotrexate was not different between groups but women in group 1 had significantly more diarrhea (36% vs 21%, p = 0.02) and fever/warmth/chills (44% vs 30%, p = 0.04). Moistening misoprostol before vaginal administration in a medical abortion regimen with methotrexate does not statistically improve efficacy. This trial demonstrates the importance of prospective, randomized studies to prove the relative efficacy of any medical abortion treatment regimen.

Background: Several combinations of oral or intravenous methotrexate plus vaginal misoprostol have been used for early abortion with success rates varying widely. So far, any study has evaluated the efficacy and safety of lower doses of oral methotrexate followed by vaginal misoprostol for early abortion., Objectives: To evaluate the efficacy and safety of methotrexate 25 or 50 mg orally and 800 micrograms of misoprostol vaginally 7 days after the methotrexate for abortion at

A group of 120 women with gestations from 64 to 84 days received 800 micrograms of vaginal misoprostol every 24 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects, and mean time of expulsion and vaginal bleeding. Complete abortion occurred in 104 of 120 (87%, 95% CI 79, 92) subjects. The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.2 mg/dL (SD 1.1) before treatment and 11.6 mg/dL (SD 1.0) after treatment. Statistically significant differences were found only between the success rates for white women in comparison with nonwhite women, in which case the success rates were higher for white than for nonwhite women. Vaginal bleeding lasted 8 +/- 5 days, spotting 4 +/- 3, and total bleeding 12 +/- 4 days. The acceptable expulsion time, the fact that postabortion systematic curettage was not needed, the clinically insignificant hemoglobin loss, and the success rate obtained show that misoprostol administered vaginally may be a valid method for interrupting gestations of 10-12 weeks.

A prospective trial including 300 pregnant women seeking elective abortion was conducted to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 63 days' gestation. Subjects received methotrexate 50 mg orally and were randomly allocated to receive 800 micrograms of misoprostol vaginally 3, 4, or 5 days after administration of the methotrexate. The misoprostol dose was repeated 48 and 96 h later if abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. Complete abortion occurred in 273 of 300 patients (91%, 95%, CI 87, 94%) patients. No significant statistical differences were found in the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.69). Vaginal bleeding lasted 7.1 +/- 3.8 days, spotting 4.1 +/- 2.5 days, and total bleeding 11.2 +/- 4.1 days. Side effects for methotrexate were minimal, whereas, for misoprostol they were mild and transient except for pain. The use of methotrexate and misoprostol together could be an alternative to the intramuscular use of methotrexate or the use of antiprogestins and prostaglandin for medical abortion.

A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at < or = 63 days' gestation. Subjects received 50 mg/m2 methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 micrograms of misoprostol 3, 4, or 5 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), and side effects. Eighty-six cases (93%; 95% confidence interval [CI] 85%-97%) aborted in Group I; 90 cases (92%; 95% CI 84%-96%) aborted in Group II (relative risk [RR] = 1.09; RR 95% CI 0.38-3.14); and 89 (93%; 95% CI 86%-97%) cases aborted in Group III (RR = 0.97; RR 95% CI 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 (92%; 95% CI 89%-95%) patients. Twenty-two cases (8%; 95% CI 5%-11%) resulted in failure. Side effects for methotrexate were minimal while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.

Objective: To verify the efficacy and safety of misoprostol for abortion at < or = 63 days' gestation., Method: A total of 175 women seeking elective abortion at < or = 63 days' gestation received 800 micrograms of misoprostol vaginally. This dose was repeated at 48 and 96 h if abortion did not occur. Afterwards, up to three additional 600- or 400-micrograms doses of misoprostol were administered if the uterus was not empty, as judged by ultrasound. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side-effects and vaginal bleeding., Results: Complete abortion occurred in 161/175 (92.0%; 95% CI 87-96%) subjects and 14/175 (8.0%; 95% CI 4-13%) cases failed. The immediate success rate was 77.7% with the first dose, 13.7% with the second dose and 0.6% with the third dose. The decrease in hemoglobin was statistically significant (p = 0.009) but without clinical relevance; before treatment: 11.94 mg/dl (SD 1.60) and after treatment: 11.64 mg/dl (SD 1.08). No significant differences were obtained between success rates and failures in relation to age, gravidity, parity, previous abortions, race, gestational age and side-effects. The third main dose of misoprostol showed very little efficacy. Vaginal bleeding lasted 5.5 +/- 2.8 days, spotting 5.7 +/- 3.1 days and total bleeding 11.2 +/- 3.0 days., Conclusions: The success percentage attained shows that 800 micrograms of misoprostol administered vaginally effectively causes abortion at < or = 63 days' gestation.

Misoprostol is a prostaglandin analogue with uterotonic properties. A group of 141 women with less than 70 days of pregnancy received up to 3 doses of 800 micrograms of misoprostol every 48 hr. Failure was defined as the need for surgical abortion and success as the complete expulsion of the products of conception pharmacologically. In total, 132 cases (93.6%, 95% CI 89.4-97.8) aborted pharmacologically and 9 cases (6.4%) failed. The decrease in hemoglobin was statistically significant (p = 0.001) but without clinical repercussions; before treatment: 11.95 mg/dI (SD 1.19) and after: 11.14 (SD 1.20). Statistically significant differences were not noticed between success rates and failures in relation to gravidity, parity, previous abortions, race, or age, but were noticed with a gestation upwards of 9 weeks (p = 0.01). The third dose of misoprostol showed very little efficacy. The convenience of using more frequent doses and shortening the treatment, combined with different routes of administration, are discussed.