Table 7.6GRADE summary of findings for comparison of vaginal misoprostol with placebo for the management of missed miscarriage

Number of studiesDetails of treatment regimen (dose in micrograms unless stated)Number of women or averageEffectQuality
Misoprostol (Ms)PlaceboRelative

(95% CI)
Absolute

(95% CI)
Success of medical treatment
1 meta-analysis of 2 studies

(Blohm et al., 2005; Kovavisarach & Sathapanachai, 2002 )
400 vaginal Ms69/91

(75.8%)
37/89

(41.6%)
RR 2.10

(0.97 to 4.53)
457 more per 1000

(from 12 fewer to 1000 more)
Very low
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
39/45

(86.7%)
11/38

(28.9%)
RR 2.99

(1.8 to 4.99)
576 more per 1000

(from 232 more to 1000 more)
High
1 meta-analysis of 2 studies

(Lister et al., 2005; Wood & Brain, 2002)
800 vaginal Ms

(repeat after 24 h)
35/44

(79.5%)
6/42

(14.3%)
RR 5.59

(2.62 to 11.93)
656 more per 1000

(from 237 more to 1000 more)
High
Need for further intervention
1 study

(Blohm et al., 2005)
400 vaginal Ms8/57

(14%)
23/51

(45.1%)
RR 0.31

(0.15 to 0.63)
311 fewer per 1000

(from 167 fewer to 383 fewer)
High
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
6/45

(13.3%)
27/38

(71.1%)
RR 0.19

(0.09 to 0.41)
576 fewer per 1000

(from 419 fewer to 647 fewer)
High
1 meta-analysis of 2 studies

(Lister et al., 2005; Wood & Brain, 2002)
800 vaginal Ms

(repeat after 24 h)
10/43

(23.3%)
34/41

(82.9%)
RR 0.28

(0.16 to 0.49)
597 fewer per 1000

(from 423 fewer to 697 fewer)
High
Unplanned visits to a medical facility
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
0/18

(0%)
3/16

(18.8%)
RR 0.13

(0.01 to 2.3)
163 fewer per 1000

(from 186 fewer to 244 more)
Moderate
Adverse effects: incidence of nausea and/or vomiting
1 study

(Kovavisarach & Sathapanachai, 2002)
400 vaginal Ms2/27

(7.4%)
1/27

(3.7%)
RR 2

(0.19 to 20.77)
37 more per 1000

(from 30 fewer to 732 more)
Very low
Adverse effects: incidence of nausea
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
18/52

(34.6%)
16/52

(30.8%)
RR 1.12

(0.65 to 1.96)
37 more per 1000

(from 108 fewer to 295 more)
Low
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
4/18

(22.2%)
3/16

(18.8%)
RR 1.19

(0.31 to 4.51)
36 more per 1000

(from 129 fewer to 658 more)
Moderate
Adverse effects: severity of nausea
1 study

(Blohm et al., 2005)
400 vaginal MsMean 17.4 (SD 24.7)

n = 64
Mean 14.9 (SD 23.8)

n = 62
not calculable (NC)MD 2.5 higher

(5.97 lower to 10.97 higher)

P = 0.57
Low
Adverse effects: incidence of vomiting
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
8/52

(15.4%)
7/52

(13.5%)
RR 1.14

(0.45 to 2.92)
19 more per 1000

(from 74 fewer to 258 more)
Low
1 study

(Lister et al., 2005)
800 vaginal Ms (repeat after 24 h)1/18

(5.6%)
3/16

(18.8%)
RR 0.3

(0.03 to 2.57)
131 fewer per 1000

(from 182 fewer to 294 more)
Moderate
Adverse effects: severity of vomiting
1 study

(Blohm et al., 2005)
400 vaginal MsMean 8.1 (SD 20.2)

n = 64
Mean 7.3

(SD 21.7)

n = 62
NCMD 0.8 higher

(6.53 lower to 8.13 higher)

P = 0.85
Low
Adverse effects: incidence of diarrhoea
1 study

(Kovavisarach & Sathapanachai, 2002)
400 vaginal Ms2/27

(7.4%)
0/27

(0%)
RR 5

(0.25 to 99.51)
NCVery low
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
11/52

(21.2%)
11/52

(21.2%)
RR 1

(0.48 to 2.1)
0 fewer per 1000

(from 110 fewer to 233 more)
Low
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
1/18

(5.6%)
1/16

(6.3%)
RR 0.89

(0.06 to 13.08)
7 fewer per 1000

(from 59 fewer to 755 more)
Moderate
Adverse effects: severity of diarrhoea (maximum potential score not reported)
1 study

(Blohm et al., 2005)
400 vaginal misoprostolMean 7.5 (SD 15.0)

n = 64
Mean 8.9

(SD 20.4)

n = 62
NCMD 1.4 lower

(7.67 lower to 4.87 higher)

P = 0.69
Low
Adverse effects: incidence of any gastrointestinal side effects
1 study

(Wood & Brain, 2002)
800 vaginal misoprostol

(repeat after 24 h)
1/25

(4%)
not reported

(NR)
NCNCLow
Adverse effects: incidence of fever
1 study

(Kovavisarach & Sathapanachai, 2002)
400 vaginal Ms4/27

(14.8%)
0/27

(0%)
RR 9

(0.51 to 159.43)
NCVery low
Adverse effects: incidence of infection
1 study

(Blohm et al., 2005)
400 vaginal Ms3/64

(4.7%)
0/62

(0%)
RR 6.78

(0.36 to 128.7)
NCLow
Adverse effects: incidence of pelvic inflammatory disease
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
1/52

(1.9%)
0/52

(0%)
RR 3

(0.13 to 71.99)
NCLow
Duration of bleeding (days)
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
Mean 11.65

(SD 4.4)

n = 52
Mean 10.88
(SD 4.78)

n = 52
NCMD 0.77 higher

(1 lower to 2.54 higher)
Moderate
Pain: incidence of menstrual cramping
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
11/18

(61.1%)
5/16

(31.3%)
RR 1.96

(0.87 to 4.42)
300 more per 1000

(from 41 fewer to 1000 more)
Moderate
Pain: incidence of lower abdominal pain
1 study

(Kovavisarach & Sathapanachai, 2002)
400 vaginal Ms20/27

(74.1%)
6/27

(22.2%)
RR 3.33

(1.59 to 6.99)
518 more per 1000

(from 131 more to 1000 more)
Low
Pain: severity
1 study

(Blohm et al., 2005)
400 vaginal MsMean 60.4 (SD 31.0)

n = 64
Mean 43.8

(SD 37.1)

n = 62
NCMD 16.6 higher

(4.64 to 28.56 higher)

P < 0.007
Low
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
Mean 6.0

(SD 2.7)

n = 52
Mean 5.4

(SD 2.7)

n = 52
NCMD 0.6 higher

(0.44 lower to 1.64 higher)
Moderate
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
Mean 5.6

(SD NR)

n = 16
Mean 5.2

(SD NR)

n = 16
NCMD 0.4 higher

(confidence intervals NC)

P = 0.806
Moderate
Satisfaction: reported incidence
1 study

(Lister et al., 2005)
800 vaginal Ms

(repeat after 24 h)
14/15

(93.3%)
12/15

(80%)
RR 1.17

(0.88 to 1.55)
136 more per 1000

(from 96 fewer to 440 more)
Moderate
Satisfaction: score/10
1 study

(Bagratee et al., 2004)
600 vaginal Ms

(repeat after 24 h)
Mean 8.9

(SD 1.3)

n = 52
Mean 8.7 (SD 1.5)

n = 52
NCMD 0.2 higher

(0.34 lower to 0.74 higher)
Moderate

CI confidence interval, MD mean difference, Ms misoprostol, NC not calculable, NR not reported, P probability, RR relative risk, SD standard deviation

From: 7, Management of threatened miscarriage and miscarriage

Cover of Ectopic Pregnancy and Miscarriage
Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage.
NICE Clinical Guidelines, No. 154.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG; 2012 Dec.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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