Sullivan 2009.
Methods | RCT. | |
Participants | Inclusion criteria: singleton breech presentations after 36 weeks' gestation. N = 95. Exclusion criteria: patients with contraindications to neuraxial anaesthesia, allergies to study medications. | |
Interventions |
Intervention:systemic opioids (E) + tocolytic. Systemic opioids (50 µg fentanyl). N = 47. Comparison:regional analgesia (C) + tocolytic. CSE anaesthesia (bupivacaine 2.5 mg and 15 µg fentanyl followed by 45 mg lidocaine and 15 µg epinephrine). N = 48. Both groups received terbutaline. |
|
Outcomes | Successful ECV, hypotension, decelerations of FHR, persistent decelerations, CS. | |
Notes | 1 woman excluded after randomisation before ECV because of non‐reassuring CTG. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer random‐number table. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 woman was excluded after randomisation because she underwent an emergency CS. Other possible exclusions are unclear. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | No significant differences between the 2 groups in age, parity, GA, height, weight or obstetrician predicted difficulty of version. Other biases not identified. |