Schorr 1997.
Methods | RCT. | |
Participants | Inclusion criteria: breech presentation or transverse lie. N = 69. Exclusion criteria: placenta praevia, fetal compromise, fetal growth restriction, ruptured membranes. | |
Interventions |
Intervention:regional analgesia (C) + tocolytic. Epidural analgesia with 2% lidocaine with 1:200,000 epinephrine (N = 35); prehydration with 2000 mL lactated Ringer's solution vs no epidural (N = 34). All women received 0.25 mg terbutaline SQ. ECV attempted up to 3 times, with vaginal elevation of the presenting part when necessary. N = 35. Comparison:no regional analgesia + tocolytic. N = 34. 250 mg terbutaline given as adjunct. |
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Outcomes | Successful ECV, complications, mode of birth, presentation at delivery. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation cards placed in permuted blocks of 10 by Division of Biostatistics. |
Allocation concealment (selection bias) | Low risk | Allocation put in sealed opaque envelopes, and all investigators participating in clinical aspects of the study were blinded to the randomisation sequence. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind people to the use of epidurals. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | It is not possible to blind people to the use of epidurals. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although 5 women declined randomisation, there seemed to be no exclusions and no loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | No differences in baseline data. No other biases apparent. |