Summary of findings 2. Intracervical PGE₂ compared to placebo for the induction of labour in outpatient settings.
| Intracervical PGE₂ 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 Intervention: intracervical PGE₂ 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 intracervical PGE₂ | |||||
| 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 in 48 to 72 h | Study population | RR 0.83 (0.68 to 1.02) | 43 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | ||
| 1000 per 1000 | 830 per 1000 (680 to 1000) | |||||
| Uterine hyperstimulation (with fetal heart rate changes) | Study population | RR 2.66 (0.63 to 11.25) | 488 (4 RCTs) | ⊕⊕⊝⊝ LOW 1 | ||
| 4 per 1000 | 11 per 1000 (3 to 45) | |||||
| Caesarean section | Study population | RR 0.90 (0.72 to 1.12) | 674 (7 RCTs) | ⊕⊕⊕⊝ MODERATE 2 | ||
| 310 per 1000 | 279 per 1000 (223 to 347) | |||||
| Serious neonatal morbidity or death | Study population | ‐ | (0 study) | ‐ | ||
| see comment | see comment | |||||
| Serious maternal morbidity or death | Study population | ‐ | (0 study) | ‐ | ||
| see comment | see comment | |||||
| Neonatal intensive care unit admission | Study population | RR 1.61 (0.43 to 6.05) | 215 (3 RCTs) | ⊕⊕⊝⊝ LOW 1 | ||
| 28 per 1000 | 44 per 1000 (12 to 167) | |||||
| *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 (‐1).