Mancuso 2000.
Methods | RCT. | |
Participants |
Inclusion criteria: women undergoing ECV attempt. Age 18 years or greater, singleton pregnancy, 37 weeks or more, breech or transverse presentation, intact membranes, EFW 2000 to 4000 g, reassuring fetal heart rate testing. N = 108. Exclusion criteria: placenta praevia, prior classical CS, third‐trimester bleeding, AFI < 5 or > 25 cm, known uterine malformation, suspected major fetal anomaly, active‐phase labour |
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Interventions |
Intervention:regional analgesia (C) + tocolytic. Lumbar epidural analgesia with 3 + 10 mL 2% lidocaine, with epinephrine test dose and fentanyl 100 micrograms. N = 54. Comparison:no regional analgesia + tocolytic. N = 54. All received Ringer's Lactate 1500 mL IV, and terbutaline 0.25 mg SQ. |
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Outcomes | Presentation after ECV attempt; presentation at birth; fetal bradycardia causing cessation of ECV attempts; the way women gave birth. | |
Notes | Tripler Army Medical Centre, Honolulu, Hawaii, December 1994 to June 1998. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table. |
Allocation concealment (selection bias) | Low risk | ...with group assignments sealed in sequentially numbered opaque envelopes randomisation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind people to epidurals. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | It is not possible to blind people to epidurals. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusions or loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | Baseline data were similar between groups; no evidence of other bias. |