Summary of findings 7. 80 mL versus 30 mL Foley catheter.
| 80 mL Foley catheter versus 30 mL Foley catheter for term labour induction for women with a previous caesarean section | ||||||
| Patient or population: pregnant women who previously had a lower segment CS and now have a singleton cephalic presentation after at least 36 completed weeks, not in labour, with intact membranes and BS of < 6 Setting: a large tertiary centre in South India, which carries out ˜15,000 deliveries every year. October 2011‐December 2013 Intervention: a 16 Fr Foley catheter was introduced into the cervix beyond the internal os and the bulb inflated with 80 mL of sterile water Comparison: a 16 Fr Foley catheter was introduced into the cervix beyond the internal os and the bulb inflated with 30 mL of sterile water | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with 30 mL Foley catheter | Risk with 80 mL Foley catheter | |||||
| Vaginal delivery not achieved within 24 hours | Study population | RR 1.05 (0.91 to 1.20) | 154 (1 RCT) | ⊕⊕⊕⊝ Moderate1 | ||
| 818 per 1000 | 859 per 1000 (745 to 982) | |||||
| Uterine hyperstimulation with fetal heart rate changes | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Caesarean section | Study population | RR 1.05 (0.89 to 1.24) | 154 (1 RCT) | ⊕⊕⊕⊝ Moderate1 | ||
| 766 per 1000 | 805 per 1000 (682 to 950) | |||||
| 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; Fr: French; 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 | ||||||
1Small sample size (imprecision, downgraded 1 level).