| Methods |
Women were "randomly allocated" to the study group or the control group. Randomisation was stratified by parity (nulliparas and multiparas). |
| Participants |
620 healthy women with uncomplicated breech pregnancy at 36‐38 weeks in Sudan from 1995‐2001 (135 nulliparas and 175 multiparas in the study group compared to 125 nulliparas and 185 multiparas in the control group). Ultrasound examination before randomisation excluded congenital malformation, oligohydramnios, placenta praevia, uterine abnormality. Other exclusions were previous CS, APH, hypertensive disorders, IUGR. |
| Interventions |
ECV attempt of up to 5 minutes without tocolysis versus no ECV attempt. If the procedure failed or when reversion occurred, the manoeuvre was repeated up to 3 times at subsequent antenatal visits. |
| Outcomes |
Mode of delivery, Apgar scores at 1, 5, 10 min, fetal weight. |
| Notes |
Baseline characteristics were similar except for maternal age (multiparas in control group older than study group). There were 750 ECV attempts in 310 women: 196/750 successful (26%) with greater success in multiparas. Apgar scores not reported. Additional information requested but not obtained from authors. Location: antenatal care clinic at Wad Medani Teaching Hospital, Sudan. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
'Randomly allocated.' |
| Allocation concealment (selection bias) |
Unclear risk |
Not described. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Women would have been aware of the intervention and this may have affected decisions re care in later pregnancy and at the birth. It was stated that ECV was carried out by a single obstetrician. It is not clear if this same obstetrician cared for women in the control group or was involved in other aspects of care. Staff would be aware of intervention and this may have affected other aspects of care and decision‐making at the birth. This may have had an impact on outcomes such as CS. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
It was not clear whether outcome assessment was carried out by staff who were involved in care. It is unlikely that lack of blinding of outcome assessors would have influenced some of the outcomes measured. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No loss to follow‐up reported. |
| Selective reporting (reporting bias) |
High risk |
The authors do not report on all prespecified outcomes, e.g. Apgar scores, or other key outcomes of interest, e.g. morbidity. |
| Other bias |
High risk |
Potentially high risk of bias. |
