Methotrexate (50 mg/m(2) intramuscularly and 50 mg orally) followed by
vaginal misoprostol have proven to be > 90% effective at causing abor
tion in women at less than 49 days' gestation. Although the effectiven
ess of the oral dose (which has a lower serum bioavailability) demonst
rates that a methotrexate dose of 50 mg/m(2) may be more than necessar
y, an intramuscular regimen is more advantageous because it is less co
stly. This trial was designed to investigate the potential effectivene
ss of a single dose of methotrexate, 75 mg intramuscularly, in a regim
en for early abortion. One hundred subjects received 75 mg methotrexat
e intramuscularly followed 5 to 6 days later by 800 mu g misoprostol v
aginally. The misoprostol dose was repeated if the abortion did not oc
cur. Outcome measures included successful abortion (complete abortion
without requiring a surgical procedure), duration of vaginal bleeding,
and side effects. One subject was lost to follow-up. Complete abortio
n occurred in 94 of 99 (94.9%, 95% CI 90.6, 99.3%) patients. The compl
ete abortion rate was no different for earlier gestations: 38 of 40 (9
5.0%, 95% CI 88.2, 100%) at up to 42 days' gestation and 56 of 59 (94.
9%, 95% CI 89.3, 100%) at more than 42 days' gestation (p = 0.99). Abo
rtion occurred in the 24 h following the initial or repeat misoprostol
dose (immediate success) in 70.7%; the remaining 24.2% of women who a
borted did so after a delay of 22 +/- 10 days (mean + standard deviati
on). Vaginal bleeding lasted 17 +/- 8 days and 11 +/- 7 days in immedi
ate success and delayed success patients, respectively. Overall, 77.8%
, 86.9%, and 91.9% of patients had passed the pregnancy by 14, 28, and
35 days, respectively, after receiving methotrexate. This preliminary
evaluation demonstrates that a medical abortion regimen using 75 mg m
ethotrexate intramuscularly appears to have similar effectiveness to o
ne with 50 mg/m(2) methotrexate. (C) 1997 Elsevier Science Inc. All ri
ghts reserved.