Summary of findings for the main comparison. Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus.
| Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus | ||||||
| Patient or population: third trimester labour induction in women with a viable fetus Setting: Australia, China, Denmark, Iran, Jordan, India, Italy, Israel, Nigeria, Pakistan, Singapore, Sweden, the Netherlands, USA, UK Intervention: balloon (Foley or ATAD) Comparison: vaginal prostaglandin E2 | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with vaginal prostaglandin E2 | Risk with balloon (Foley or ATAD) | |||||
| Vaginal delivery not achieved in 24 hours | Study population | RR 1.01 (0.82 to 1.26) | 1685 (7 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| 528 per 1000 | 533 per 1000 (433 to 665) | |||||
| Uterine hyperstimulation with FHR changes | Study population | RR 0.35 (0.18 to 0.67) | 1966 (6 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 31 per 1000 | 11 per 1000 (6 to 21) | |||||
| Caesarean section | Study population | RR 1.00 (0.92 to 1.09) | 6619 (28 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 238 per 1000 | 238 per 1000 (219 to 260) | |||||
| Serious neonatal morbidity or perinatal death | Study population | RR 0.48 (0.25 to 0.93) | 2757 (8 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 20 per 1000 | 9 per 1000 (5 to 18) | |||||
| Serious maternal morbidity or death | Study population | RR 0.20 (0.01 to 4.12) | 1481 (4 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 3 | ||
| 3 per 1000 | 1 per 1000 (0 to 11) | |||||
| Apgar score < 7 at 5 minutes | Study population | RR 0.74 (0.49 to 1.14) | 4271 (14 RCTs) | ⊕⊕⊝⊝ LOW 1 4 | ||
| 22 per 1000 | 16 per 1000 (11 to 25) | |||||
| Neonatal intensive care unit admission | Study population | RR 0.82 (0.65 to 1.04) | 3647 (12 RCTs) | ⊕⊕⊝⊝ LOW 1 4 | ||
| 74 per 1000 | 60 per 1000 (48 to 77) | |||||
| *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 | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event)
2We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I2 = >30%)
3We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events
4We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect