Summary of findings 2. Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus.
| Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus | ||||||
| Patient or population: third trimester induction of labour in women with a viable fetus Setting: Brazil, Egypt, India, Iran, Nigeria, the Netherlands, Sweden Intervention: balloon (Foley or ATAD) Comparison: low‐dose vaginal misoprostol | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with low‐dose vaginal misoprostol | Risk with balloon (Foley or ATAD) | |||||
| Vaginal delivery not achieved in 24 hours | Study population | RR 1.09 (0.85 to 1.39) | 340 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| 412 per 1000 | 449 per 1000 (350 to 573) | |||||
| Uterine hyperstimulation with FHR changes | Study population | RR 0.39 (0.18 to 0.85) | 1322 (8 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 33 per 1000 | 13 per 1000 (6 to 28) | |||||
| Caesarean section | Study population | RR 1.28 (1.02 to 1.60) | 1756 (12 RCTs) | ⊕⊕⊝⊝ LOW 1 3 | ||
| 243 per 1000 | 311 per 1000 (247 to 388) | |||||
| Serious neonatal morbidity or perinatal death | Study population | RR 0.58 (0.12 to 2.66) | 381 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 4 | ||
| 21 per 1000 | 12 per 1000 (2 to 55) | |||||
| Serious maternal morbidity or death | Study population | not estimable | 464 (4 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 5 | no events occurred in included studies | |
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| Apgar score < 7 at 5 minutes | Study population | RR 1.00 (0.50 to 1.97) | 941 (7 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| 30 per 1000 | 30 per 1000 (15 to 59) | |||||
| Neonatal intensive care unit admission | Study population | RR 1.00 (0.61 to 1.63) | 1302 (9 RCTs) | ⊕⊕⊝⊝ LOW 1 2 6 | ||
| 47 per 1000 | 47 per 1000 (29 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 imprecision due to wide CI crossing the line of no effect
3We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I2 = >30%)
4We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events
5 We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and no events reported in included studies
6 Although there was some evidence suggesting small‐study effect we did not downgrade for publication bias because individual studies did not reach statistical significance and there was low heterogeneity across all studies for this outcome. Also, no difference was found between fixed‐effect or random‐effect analyses