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Summary of recent misoprostol-only studies
The following table summarizes a number of recent studies investigating the efficacy of misoprostol as a single agent abortifacient. It should be noted that the sample-sizes of the reported studies have been relatively small and thus the conclusions should be interpreted with caution.
|
Study
|
Gestational age
|
Sample size
|
Route
|
Dosing schedule and protocol
|
Efficacy
|
Comments
|
|
Jain, et al. (2002) [1]
|
< 56 days
|
125
|
PV
|
800 µg of moistened misoprostol
was administered vaginally. The dose was repeated every 24 hours
up to three doses if the abortion failed to occur. This was a
randomized, double blinded, placebo-controlled trial comparing
the misoprostol-only regimen to a mifepristone/misoprostol regimen.
|
Total: 88%
After 1 dose: 72% After 2 doses: 86% After 3 doses: 88% |
Mifepristone/misoprostol regimen
was 95.7% effective.
|
|
Tang, et al. (2002) [2]
|
< 12 weeks
|
50
|
PO
|
600 µg of sublingual misoprostol
was administered. The dose was repeated every 3 hours for a maximum
for five doses.
|
Total: 86% |
Mean # doses was 4.1
Mean vaginal bleeding time was 15 days |
|
Carbonell, et al. (2001) [3]
|
42-63 days
|
300
|
PV
|
1000 µg of moistened misoprostol
was self-administered vaginally by women (at home). The dose was
repeated every 24 hours for a maximum of three doses.
|
Total: 93% complete abortion (69%
w/in 24 hrs)
|
Mean vaginal bleeding time was
14.7 days
|
|
Bugalho, et al. (2000) [4]
|
< 42 days
|
103
|
PV
|
800 µg of moistened misoprostol
was administered vaginally. The dose was repeated one week later
if abortion was not complete.
|
After 1 dose: 87.1% (71.8% w/in
24 hrs)
After 2 doses: 92% |
-
|
|
Ngai et al. (2000) [5]
|
< 9 weeks
|
1) 40
2) 40 |
1) PV
2) PV |
1) 800 µg of moistened misoprostol
was administered vaginally. The dose was repeated on Day 3 and
Day 5.
2) 800 µg of dry misoprostol was administered vaginally. The dose was repeated on Day 3 and Day 5. |
1) Total: 85%
2) Total: 65% |
40% of women said they would prefer
surgical abortion
|
|
Carbonell, et al. (1999) [6]
|
35-63 days
|
720
|
PV
|
800 µg of moistened misoprostol
was self-administered vaginally by women (at home). The dose was
repeated every 24 hours for a maximum of three doses.
|
Total: 89.4%
(65.4% w/ 1 dose) |
Efficacy decreased with increased
gestational age
|
| Bebbington, et al. (2002) [7] | Mid-trimester | 1) 65 2) 49 |
1) PO 2) PV |
1) 200 µg of misoprostol was
administered orally every hour for three hours. This was followed
by 400 µg every four hours for up to 24 hours. 2) 400 µg of misoprostol was administered vaginally every four hours for 24 hours. |
1) Total: 38.5% 2) Total: 85.7% |
Study only allowed 24 hrs for a complete abortion to take place |
|
Tang, et al. (2001) [8]
|
13-20 weeks
|
18
|
PO
|
400 µg of sublingual misoprostol
was administered. The dose was repeated every 3 hours for a maximum
of 5 doses.
|
Total: 100%
|
Median induction to abortion time
was 11.6 hours
|
|
Jain, et al. (1999) [9]
|
12-22 weeks
|
1) 47
2) 37 |
PV
PV |
1) 200 µg of misoprostol
was administered vaginally every 6 hours for up to 48 hours.
2) 200 µg of misoprostol was administered vaginally every 12 hours for up to 48 hours. |
1) 80.9% aborted w/in 24 hours;
87.2% w/in 48 hours
2) 86.5% aborted w/in 24 hours; 89.2% w/in 48 hours |
Complete abortion rate was greater
with non-viable pregnancies
|
References:
[1] Jain JK, Dutton C, Harwood B, Meckstroth KR, Mishell DR. A prospective randomize, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Human Reproduction 2002; 17(6): 1477-1482.
[2] Tang OS, Miao BY, Lee SWH, Ho PC. Pilot study on the use of repeated doses of sublingual misoprostol in termination of pregnancy up to 12 weeks gestation: Efficacy and acceptability. Human Reproduction 2002; 17(3): 654-658.
[3] Carbonell J, Rodrigues J, Aragón S, Velazco A, Tanda R, Sánchez C, Barambio S, Chami S, Valero F. Vaginal misoprostol 1000 µg for early abortion. Contraception 2001; 63: 131-136.
[4] Bugalho A, Mocumbi S, Faúndes A, David E. Termination of pregnancies of <6 weeks gestation with a single dose of 800 µg of vaginal misoprostol. Contraception. 2000; 61: 47-50.
[5] Ngai SW, Tang OS, Chan YM, Ho PC. Vaginal misoprostol alone for medical abortion up to 9 weeks of gestation: Efficacy and acceptability. Human Reproduction. 2000; 15(5): 1159-1162.
[6] Carbonell Esteve J, Varela L, Velazco A., Tanda R, Cabezas E, Sánchez C. Early abortion with 800 µg of misoprostol by the vaginal route. Contraception. 1999; 59; 219-225.
[7] Bebbington MW, Kent N, Lim K, Gagnon A, Delisle M, Tessier F, Wilson RD. A randomized controlled trial comparing two protocols for the use of misoprostol in midtrimester pregnancy termination. Am J Obstet. Gynecol. 2002; 187(4): 853-857.
[8] Tang OS, Ho PC. Pilot study on the use of sublingual misoprostol for medical abortion. Contraception 2001; 64: 315-317.
[9] Jain J, Kuo J, Mishell D. A comparison of two dosing regimens of intravaginal misoprostol for second-trimester pregnancy termination. Am J Obstet. Gynecol. 1999; 93(4): 571-575.