L. Varela

The use of misoprostol for termination of early pregnancy

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.

Early abortion with 800 μg of misoprostol by the vaginal route

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 μg 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.

Vaginal misoprostol for late first trimester abortion

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 randomized trial of the effect of moistening misoprostol before vaginal administration when used with methotrexate for abortion

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.

25 mg or 50 mg of Oral Methotrexate Followed by Vaginal Misoprostol 7 Days after for Early Abortion

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 μg of misoprostol vaginally 7 days after the methotrexate for abortion at ≤56 days of gestation. Study Design: Three-hundred and ten pregnant women seeking elective abortion were randomly allocated to receive 25 mg (group I) or 50 mg (group II) of methotrexate orally and 800 μg of misoprostol vaginally 7 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), side effects and vaginal bleeding. Relative risks were used for the comparison between the outcomes from both treatment regimens. Results: In group I aborted 135/148 cases (91%, 95% CI 85, 95%), and 139/154 cases (90%, 95% CI 84, 94%) aborted in group II (relative risk [RR] = 1.01, RR 95% CI 0.94, 1.09). Conclusions: The two treatment regimens showed the same efficacy and safety, so it would be advisable at least to use the smaller methotrexate dose, i.e. 25 mg.