Summary of findings 6. Vaginal isosorbide mononitrate versus Foley catheter.
| Vaginal isosorbide mononitrate versus Foley catheter for term labour induction for women with a previous caesarean section | ||||||
| Patient or population: pregnant women with 1 previous lower segment caesarean section at 37 weeks and beyond, with a BS of ≤ 6, intact membranes, reactive non‐stress test, normal umbilical arterial Doppler indices, absence of labour and willingness of women to participate in the study Setting: Egypt Intervention: vaginal isosorbide mononitrate (40 mg) inserted into the posterior fornix of the vagina once Comparison: Foley catheter No. 14‐16 Fr inserted into the endocervical canal, beyond the internal os and inflated with 50‐60 mL of normal saline | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with Foley catheter | Risk with isosorbide mononitrate | |||||
| Vaginal delivery not achieved within 24 hours | Study population | RR 2.63 (1.32 to 5.21) | 80 (1 RCT) | ⊕⊕⊝⊝ Low1, 2 | ||
| 200 per 1000 | 526 per 1000 (264 to 1000) | |||||
| Uterine hyperstimulation with fetal heart rate changes | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Caesarean section | Study population | RR 1.00 (0.39 to 2.59) | 80 (1 RCT) | ⊕⊝⊝⊝ Very low1, 3 | ||
| 175 per 1000 | 175 per 1000 (68 to 453) | |||||
| 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 | ||||||
1 One study with design limitations (risk of bias, downgraded 1 level). 2 Small sample size (imprecision, downgraded 1 level). 3 Wide CI crossing the line of no effect, small sample size (imprecision, downgraded 2 levels).