Summary of findings 3. Foley catheter versus intravenous (IV) oxytocin.
Foley catheter compared with IV oxytocin for term labour induction for women with a previous caesarean section | ||||||
Patient or population: pregnant women with a previous low transverse caesarean section, singleton live pregnancy with cephalic presentation, period of gestation > 28 weeks and BS < 5 were included in the study, with unfavourable cervix Setting: Chandigarh, India. July 2004–November 2005 Intervention: Foley catheter balloon inflated with 30 mL of sterile saline Comparison: intravenous oxytocin (low dose IV oxytocin, starting at 1 mU/min and increasing if contractions were not frequent after 1 hour) | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with oxytocin | Risk with Foley catheter | |||||
Vaginal delivery not achieved within 24 hours | Study population | RR 1.47 (0.89 to 2.44) | 53 (1 RCT) | ⊕⊕⊝⊝ Low1 | ||
444 per 1000 | 653 per 1000 (396 to 1000) | |||||
Uterine hyperstimulation with fetal heart rate changes | Study population | RR 3.11 (0.13 to 73.09) | 53 (1 RCT) | ⊕⊕⊝⊝ Low1 | ||
0 per 1000 | 0 per 1000 (0 to 0) | |||||
Caesarean section | Study population | RR 0.93 (0.45 to 1.92) | 53 (1 RCT) | ⊕⊕⊝⊝ Low1 | ||
370 per 1000 | 344 per 1000 (167 to 711) | |||||
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 |
1Wide confidence interval crossing the line of no effect, small sample size, and few events (imprecision, downgraded 2 levels).