Summary of findings for the main comparison. Amniotic membranes sweeping compared to no treatment/sham.
| Amniotic membrane sweeping compared to no treatment/sham for induction of labour | ||||||
| Patient or population: pregnant women carrying a live fetus at or near term (≥ 36 weeks' gestation). Setting: antenatal environments where amniotic membrane sweeping is likely to be used. Intervention: amniotic membrane sweeping Comparison: no treatment/sham | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with no treatment/sham | Risk with amniotic membranes sweeping | |||||
| Spontaneous onset of labour | Study population | RR 1.21 (1.08 to 1.34) | 3170 (17 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ||
| 598 per 1000 | 723 per 1000 (646 to 801) | |||||
| Induction of labour | Study population | RR 0.73 (0.56 to 0.94) | 3224 (16 RCTs) | ⊕⊕⊝⊝ LOW 3 4 | ||
| 313 per 1000 | 228 per 1000 (175 to 294) | |||||
| Caesarean section | Study population | RR 0.94 (0.85 to 1.04) | 5499 (32 RCTs) | ⊕⊕⊕⊝ MODERATE 5 | ||
| 165 per 1000 | 155 per 1000 (140 to 171) | |||||
| Spontaneous vaginal birth | Study population | RR 1.03 (0.99 to 1.07) | 4538 (26 RCTs) | ⊕⊕⊕⊝ MODERATE 6 | ||
| 711 per 1000 | 733 per 1000 (704 to 761) | |||||
| Uterine hyperstimulation with/without fetal heart rate (FHR) changes ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | No study reported on this outcome. |
| Maternal death or serious maternal morbidity | Study population | RR 0.83 (0.57 to 1.20) | 2749 (17 RCTs) | ⊕⊕⊝⊝ LOW 7 8 | ||
| 44 per 1000 | 36 per 1000 (25 to 53) | |||||
| Neonatal death or serious neonatal perinatal morbidity | Study population | RR 0.83 (0.59 to 1.17) | 3696 (18 RCTs) | ⊕⊕⊝⊝ LOW 9 10 | ||
| 36 per 1000 | 30 per 1000 (22 to 43) | |||||
| *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. | ||||||
1 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Three trials had unclear risk of bias for randomisation. Nine trials had unclear allocation concealment and one had a high risk of bias. No trial was blinded. Twelve trials had unclear risk of bias for blinding of outcome assessment and three were high risk of bias. One trial was at high risk of selective reporting bias.
2 We downgraded (1) level for serious risk of inconsistency due to evidence of statistical heterogeneity (Tau² = 0.03; Chi² = 59.79, df = 16 (P < 0.00001); I² = 73%)
3 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Three trials had unclear risk of bias for randomisation. Ten trials had unclear allocation concealment. No trial was blinded. Ten trials had unclear risk of bias for blinding of outcome assessment and two were high risk of bias. Two trials were at high risk of attrition bias and two trials were at high risk of selective reporting bias. One trial was at high risk of selective reporting bias.
4 We downgraded (1) level for serious risk of inconsistency due to evidence of statistical heterogeneity (Tau² = 0.17; Chi² = 60.72, df = 15 (P < 0.00001); I² = 75%)
5 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Seven trials had unclear risk of bias for randomisation with one trial at a high risk of bias. Nineteen trials had unclear allocation concealment and two had a high risk of bias. No trial was blinded. Twenty‐two trials had unclear risk of bias for blinding of outcome assessment and five were high risk of bias. One trial was at high risk of attrition bias and two trials were at high risk of selective reporting bias.
6 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Five trials had unclear risk of bias for randomisation with one trial at a high risk of bias. Sixteen trials had unclear allocation concealment. No trial was blinded. Nineteen trials had unclear risk of bias for blinding of outcome assessment and three were high risk of bias. Two trials were at high risk of selective reporting bias.
7 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Two trials had unclear risk of bias for randomisation with one trial at a high risk of bias. Twelve trials had unclear allocation concealment and one trial had a high risk of bias. No trial was blinded. Eleven trials had unclear risk of bias for blinding of outcome assessment and three were high risk of bias. Two trials were at high risk of attrition bias and two trials were at high risk of selective reporting bias.
8 We downgraded (1) level for serious risk of imprecision due to the total (cumulative) sample size of 2749 being less than the optimal information size (OIS) of 15342.
9 We downgraded (1) level for serious risk of bias due to evidence of design limitations in all trials. Two trials had unclear risk of bias for randomisation. Ten trials had unclear allocation concealment. No trial was blinded. Eleven trials had unclear risk of bias for blinding of outcome assessment and two were high risk of bias. Two trials had a high risk of attrition bias and two trials had a high risk of reporting bias
10 We downgraded (1) level for serious risk of imprecision due to the total (cumulative) sample size of 3696 being less than the optimal information size (OIS) of 18716.