Summary of findings 1. Induction of labour versus expectant management for suspected fetal macrosomia.
Induction of labour versus expectant management for suspected fetal macrosomia | |||||
Patient or population: women with term or near term (> 37 weeks' gestation) with suspected fetal macrosomia Setting: data from four trials: a multi‐centre study in France, Belgium and Switzerland and studies in UK, Israel and USA Intervention: induction of labour Comparison: expectant management | |||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | |
Risk with expectant management | Risk with Induction | ||||
Caesarean section | Study population | RR 0.91 (0.76 to 1.09) | 1190 (4 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | |
293 per 1000 | 267 per 1000 (223 to 320) | ||||
Moderate | |||||
296 per 1000 | 269 per 1000 (225 to 323) | ||||
Instrumental delivery | Study population | RR 0.86 (0.65 to 1.13) | 1190 (4 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | |
152 per 1000 | 130 per 1000 (99 to 171) | ||||
Moderate | |||||
148 per 1000 | 127 per 1000 (96 to 167) | ||||
Shoulder dystocia | Study population | RR 0.60 (0.37 to 0.98) | 1190 (4 RCTs) | ⊕⊕⊕⊝ MODERATE 1 3 | |
68 per 1000 | 41 per 1000 (25 to 67) | ||||
Moderate | |||||
61 per 1000 | 36 per 1000 (22 to 59) | ||||
Brachial plexus injury | Study population | RR 0.21 (0.01 to 4.28) | 1190 (4 RCTs) | ⊕⊕⊝⊝ LOW 4 | |
3 per 1000 | 1 per 1000 (0 to 14) | ||||
Fracture (any) | Study population | RR 0.20 (0.05 to 0.79) | 1190 (4 RCTs) | ⊕⊕⊕⊕ HIGH 5 | |
20 per 1000 | 4 per 1000 (1 to 16) | ||||
Moderate | |||||
10 per 1000 | 2 per 1000 (0 to 8) | ||||
Low Apgar score (5 minutes) | Study population | RR 1.51 (0.25 to 9.02) | 858 (2 RCTs) | ⊕⊕⊝⊝ LOW 4 | |
5 per 1000 | 7 per 1000 (1 to 42) | ||||
Moderate | |||||
2 per 1000 | 4 per 1000 (1 to 22) | ||||
Low arterial cord blood pH (< 7.10) | Study population | RR 1.01 (0.46 to 2.22) | 818 (1 RCT) | ⊕⊕⊕⊝ MODERATE 2 | |
29 per 1000 | 29 per 1000 (13 to 65) | ||||
Moderate | |||||
29 per 1000 | 29 per 1000 (13 to 65) | ||||
*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; OR: Odds 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 Studies contributing data were at risk of bias (lack of blinding)
2 Wide 95% CI crossing the line of no effect
3 We downgraded this outcome for lack of blinding (clinical assessment of dystocia could be affected by lack of blinding)
4 Wide 95% CI crossing the line of no effect and low event rate
5 Not downgraded for low event rates due to fairly large sample, and 95% CI not crossing the line of no effect, and we considered this outcome was less likely to be affected by lack of blinding