| Methods |
An international multicentre randomised controlled trial with randomisation stratified by parity using a centralised telephone randomisation system. Breech verified within 4 days of randomisation, and confirmed prior to ECV attempt. |
| Participants |
All nulliparous women with any breech presentation and multiparous women with a frank breech presentation were eligible for the trial if they had a live singleton fetus and a gestational age of between 34 weeks, 0 days and 36 weeks 0 days. Women were excluded if they had a parity > 4, if they planned to move to a non‐trial centre, or if there was any contraindication to labour or vaginal birth (such as placenta previa, or previous classical caesarean section), to ECV (such as fetal heart rate abnormalities, abruptio placenta, fetal anomalies, uterine anomalies, oligohydramnios, rupture of membranes, over distended uterus) or to early ECV (such as fetus engaged in the pelvis, an increased risk of preterm labour, increased risk of abruptio placenta). |
| Interventions |
ECV was begun between 34 weeks 0 days and 36 weeks 0 days in the early group (n = 117); and between 37 weeks 0 days and 38 weeks 0 days in the delayed group (n = 116). Tocolysis recommended either routinely or selectively in both groups; analgesia permitted. |
| Outcomes |
Primary: presentation at delivery.
Other: caesarean section rate; serious fetal complication; preterm birth < 37 weeks; women's view's about ECV. |
| Notes |
n = 233.
Funded by Canadian Institutes of Health Research; coordinated through the Maternal Infant and Reproductive Health Research Unit (MIRU) at the University of Toronto, Canada. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Stratification by parity, random block sizes. External randomisation service. |
| Allocation concealment (selection bias) |
Low risk |
External telephone randomisation service. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Unblinded intervention. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Interim analysis was carried out by blinded assessors. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Analysis by intention‐to‐treat. 233 women randomised, outcome data available for 132 women and babies. |
| Selective reporting (reporting bias) |
Low risk |
Protocol provided by the authors. Outcome reporting bias not apparent. |
| Other bias |
Low risk |
Other bias not apparent. |
