Summary of findings 3. Vaginal misoprostol compared to placebo for the induction of labour in outpatient settings.
| Vaginal misoprostol compared to placebo for the induction of labour in outpatient settings | ||||||
| Patient or population: women requiring induction of labour Setting: outpatient clinics and hospitals in the USA and Nigeria Intervention: Vaginal misoprostol Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with vaginal misoprostol | |||||
| Vaginal birth not achieved within 24 h | Study population | ‐ | (0 study) | ‐ | No included trial reported this outcome. | |
| see comment | see comment | |||||
| Vaginal birth not achieved within 48 and 72 h | Study population | ‐ | (0 study) | ‐ | No included trial reported this outcome. | |
| see comment | see comment | |||||
| Uterine hyperstimulation (with fetal heart rate changes) | Study population | RR 1.97 (0.43 to 9.00) | 265 (3 RCTs) | ⊕⊕⊝⊝ LOW 1 | ||
| 15 per 1000 | 29 per 1000 (6 to 131) | |||||
| Caesarean section | Study population | RR 0.94 (0.61 to 1.46) | 325 (4 RCTs) | ⊕⊕⊝⊝ LOW 2 | ||
| 206 per 1000 | 194 per 1000 (126 to 301) | |||||
| Serious neonatal morbidity or death | Study population | RR 0.34 (0.01 to 8.14) | 77 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Study reported perinatal deaths. | |
| 26 per 1000 | 9 per 1000 (0 to 209) | |||||
| Serious maternal morbidity or death | Study population | ‐ | (0 study) | ‐ | No included trial reported this outcome. | |
| see comment | see comment | |||||
| Neonatal intensive care unit admission | Study population | RR 0.89 (0.54 to 1.47) | 325 (4 RCTs) | ⊕⊕⊝⊝ LOW 2 | ||
| 147 per 1000 | 131 per 1000 (79 to 216) | |||||
| *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; OR: odds ratio | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Wide confidence interval crossing the line of no effect, few events and small sample size (‐2).
2 Wide confidence interval crossing the line of no effect and small sample size (‐2).