Table I.7.11GRADE findings for comparison of oral misoprostol with sublingual misoprostol for the management of missed miscarriage

Quality assessmentNumber of women or averageEffectQuality
Number of studiesDesignLimitationsInconsistencyIndirectnessImprecisionDetails of treatment regimen (dose in micrograms unless stated)OralSublingualRelative (95% CI)Absolute (95% CI) and P value (if stated)
Success of medical treatment
1 study

(Ayudhaya et al., 2006)
randomised trialserious1no serious inconsistencyno serious indirectnessserious2Oral: 400 misoprostol (Ms) × 6

Sublingual: 400 Ms × 6
17/66

(25.8%)
15/70

(21.4%)
RR 1.2

(0.65 to 2.21)
43 more per 1000

(from 75 fewer to 259 more)
Low
1 study

(Kushwah & Singh, 2009)
randomised trialserious1no serious inconsistencyno serious indirectnessno serious imprecision200 mg oral mifepristone (Mf), plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
42/50

(84%)
46/50

(92%)
RR 0.91

(0.79 to 1.06)
83 fewer per 1000

(from 193 fewer to 55 more)
Moderate
Adverse effects: incidence of nausea or vomiting
1 study

(Ayudhaya et al., 2006)
randomised trialno serious limitationsno serious inconsistencyno serious indirectnessserious2Oral: 400 Ms × 6

Sublingual: 400 Ms × 6
3/66

(4.5%)
2/70

(2.9%)
RR 1.59

(0.27 to 9.22)
17 more per 1000

(from 21 fewer to 235 more)
Moderate
Adverse effects: incidence of nausea
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessserious2200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
26/50

(52%)
17/50

(34%)
RR 1.53

(0.96 to 2.44)
180 more per 1000

(from 14 fewer to 490 more)
Low
Adverse effects: incidence of vomiting
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessno serious imprecision200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
22/50

(44%)
11/50

(22%)
RR 2

(1.09 to 3.68)
220 more per 1000

(from 20 more to 590 more)
Moderate
Adverse effects: incidence of diarrhoea
1 study

(Ayudhaya et al., 2006)
randomised trialno serious limitationsno serious inconsistencyno serious indirectnessserious2Oral: 400 Ms × 6

Sublingual: 400 Ms × 6
7/66

(10.6%)
6/70

(8.6%)
RR 1.24

(0.44 to 3.49)
21 more per 1000

(from 48 fewer to 213 more)
Moderate
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessserious2200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
28/50

(56%)
24/50

(48%)
RR 1.17

(0.8 to 1.7)
82 more per 1000

(from 96 fewer to 336 more)
Low
Adverse effects: incidence of fever
1 study

(Ayudhaya et al., 2006)
randomised trialno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionOral: 400 Ms × 6

Sublingual: 400 Ms × 6
2/66

(3%)
15/70

(21.4%)
RR 0.14

(0.03 to 0.59)
184 fewer per 1000

(from 88 fewer to 208 fewer)
High
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessno serious imprecision200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
26/50

(52%)
10/50

(20%)
RR 2.6

(1.41 to 4.81)
320 more per 1000

(from 82 more to 762 more)
Moderate
Adverse effects: incidence of chills
1 study

(Ayudhaya et al., 2006)
randomised trialno serious limitationsno serious inconsistencyno serious indirectnessserious2Oral: 400 Ms × 6

Sublingual: 400 Ms × 6
0/66

(0%)
4/70

(5.7%)
RR 0.12

(0.01 to 2.15)
50 fewer per 1000

(from 57 fewer to 66 more)
Moderate
Pain: incidence
1 study

(Ayudhaya et al., 2006)
randomised trialno serious limitationsno serious inconsistencyno serious indirectnessserious2Oral: 400 Ms × 6

Sublingual: 400 Ms × 6
40/66

(60.6%)
47/70

(67.1%)
RR 0.9

(0.7 to 1.16)
67 fewer per 1000

(from 201 fewer to 107 more)
Moderate
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessno serious imprecision200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
44/50

(88%)
23/50

(46%)
RR 1.91

(1.39 to 2.63)
419 more per 1000

(from 179 more to 750 more)
Moderate
Satisfaction: reported incidence
1 study

(Kushwah & Singh, 2009)
randomised trialserious3no serious inconsistencyno serious indirectnessno serious imprecision200 mg oral Mf, plus:

Oral: 600 Ms

Sublingual: 600 Ms

(+ 400 Ms × 3 after 12 hours if needed)
36/50

(72%)
46/50

(92%)
RR 0.78

(0.65 to 0.95)
202 fewer per 1000

(from 46 fewer to 322 fewer)
Moderate

CI confidence interval, Mf mifepristone, Ms misoprostol, P probability, RR relative risk

1

Lack of blinding

2

Wide confidence intervals

3

Unclear how and when this outcome was assessed

From: Appendix I, GRADE tables

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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