Summary of findings 8. Vaginal PGE2 pessary versus vaginal PGE2 tablet.
| Vaginal PGE2 pessary versus vaginal PGE2 tablet for term labour induction for women with a previous caesarean section | ||||||
| Patient or population: women with a previous caesarean section, a live singleton fetus (37‐42 weeks of gestation) in cephalic presentation and a reactive non‐stress test, BS of ≤ 7 before onset of labour, no spontaneous contractions (< 4 contractions within 20 minutes) Setting: large Governmental hospital, Saudi Arabia. February 2009‐March 2013 Intervention: vaginal PGE2 pessary (10 mg dinoprostone sustained‐release vaginal pessary) Comparison: vaginal PGE2 tablet (1.5 mg dinoprostone vaginal tablet) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with dinoprostone tablet | Risk with dinoprostone pessary | |||||
| Vaginal delivery not achieved within 24 hours | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Uterine hyperstimulation with fetal heart rate changes | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Caesarean section | Study population | RR 1.09 (0.74 to 1.60) | 200 (1 RCT) | ⊕⊝⊝⊝ Very low1, 2 | ||
| 330 per 1000 | 360 per 1000 (244 to 528) | |||||
| Serious neonatal morbidity or perinatal death | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Serious maternal morbidity or death | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *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). BS: Bishop score; CI: Confidence interval; RR: Risk 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 | ||||||
1One study with design limitations (risk of bias, downgraded 1 level). 2Wide confidence crossing the line of no effect, small sample size (imprecision, downgraded 2 levels).