Summary of findings for the main comparison. Vaginal misoprostol compared to placebo for early fetal death (less than 24 weeks).
| Vaginal misoprostol compared to placebo for early fetal death (less than 24 weeks) | ||||||
| Patient or population: early fetal death (less than 24 weeks) Setting: worldwide Intervention: vaginal misoprostol Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with vaginal misoprostol | |||||
| Complete miscarriage | Study population | RR 4.23 (3.01 to 5.94) | 305 women (5 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | There were differences in timing of outcome measurement: after 24 hours (2 studies), after 48 hours (2 studies) or after 7 days (1 study). | |
| 189 per 1.000 | 800 per 1.000 (569 to 1.000) | |||||
| Pelvic infection | Study population | not estimable | (studies) | ‐ | ||
| 0 per 1.000 | 0 per 1.000 (0 to 0) | |||||
| Nausea | Study population | RR 1.38 (0.43 to 4.40) | 88 women (2 RCTs) | ⊕⊕⊝⊝ LOW 3 4 | ||
| 93 per 1.000 | 128 per 1.000 (40 to 409) | |||||
| Diarrhoea | Study population | RR 2.21 (0.35 to 14.06) | 88 women (2 RCTs) | ⊕⊕⊝⊝ LOW 3 4 | ||
| 23 per 1.000 | 51 per 1.000 (8 to 327) | |||||
| Blood loss: haemoglobin difference > 10 g/L | Study population | RR 1.25 (0.38 to 4.12) | 50 women (1 RCT) | ⊕⊝⊝⊝ VERY LOW 5 6 | ||
| 160 per 1.000 | 200 per 1.000 (61 to 659) | |||||
| Pain (opiate use) | Study population | RR 5.00 (0.25 to 101.11) | 84 women (1 RCT) |
⊕⊝⊝⊝4 6 VERY LOW |
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| 0 per 1.000 | 0 per 1.000 (0 to 0) | |||||
| Woman’s satisfaction/acceptability of method | Study population | RR 1.17 (0.83 to 1.64) | 32 women (1 RCT) | ⊕⊕⊝⊝ LOW 6 | ||
| 750 per 1.000 | 878 per 1.000 (622 to 1.000) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Serious indirectness: differences in medication regimens used between the included studies. However: very strong association; dose‐response relation (‐1).
2 Serious risk of bias: problems with blinding in various studies, downgraded because of limitation in study design (‐1).
3 Serious imprecision: only two studies with relatively few patients (‐1).
4 Serious risk of bias: unclear allocation concealment (‐1).
5 Serious risk of indirect evidence: haematocrit difference was used to estimate the amount of blood loss (‐1).
6 Serious imprecision: only one study included, wide confidence interval (‐2).