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Summary of key misoprostol-only studies
The following table summarizes a number of influential studies investigating the efficacy of misoprostol as a single agent abortifacient. Please note that the sample-sizes reported in many of these 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 [1].
|
< 56 days
|
125
|
PV
|
800µg 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 [2].
|
< 12 weeks
|
50
|
PO
|
600µg 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 [3].
|
42-63 days
|
300
|
PV
|
1000µg 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 [4].
|
< 42 days
|
103
|
PV
|
800µg 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 [5].
|
< 9 weeks
|
1) 40
2) 40 |
1) PV
2) PV |
1) 800µg of moistened misoprostol
was administered vaginally. The dose was repeated on Day 3 and
Day 5.
2) 800µg 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 [6].
|
35-63 days
|
720
|
PV
|
800µg 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 [7]. | Mid-trimester | 1) 65 2) 49 |
1) PO 2) PV |
1) 200µg of misoprostol was
administered orally every hour for three hours. This was followed
by 400µg every four hours for up to 24 hours. 2) 400µg 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 [8].
|
13-20 weeks
|
18
|
PO
|
400µg 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 [9].
|
12-22 weeks
|
1) 47
2) 37 |
PV
PV |
1) 200µg of misoprostol
was administered vaginally every 6 hours for up to 48 hours.
2) 200µg 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
|
Citations in this section For the full bibliographic citations of all
references listed in this section, please visit our reference section.
[1] Jain J et al, 2002.
[2] Tang O et al, 2002.
[3] Carbonell et al, 2001.
[4] Bugalho A et al, 2000.
[5] Ngai S et al, 2000.
[6] Carbonell E et al, 1999.
[7] Bebbington et al, 2002.
[8] Tang O and Ho P, 2001.
[9] Jain J, Kuo J and Mishell D, 1999.