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. 2015 Feb 12;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4

Vani 2009.

Methods RCT.
Participants Inclusion criteria: healthy women, singleton fetus in breech presentation, 37 to 39 weeks with intact membranes, no signs of labour and a clinically EFW 2 to 4 kg. USS performed to confirm breech presentation and to ascertain fetal neck position and location of the placenta. N = 114.
Exclusion criteria: AFI outside range of 5 to 25, fetal hyperextended neck, placenta previa, gross fetal anomalies, hypertension, gestational diabetes, antepartum haemorrhage, uterine scar (from CS, myomectomy or perforation), uterine malformation allergy or contraindication to salbutamol or contraindication to a trial of labour even if in cephalic presentation.
Interventions Intervention:tocolytic: salbutamol ‐ beta stimulant (A1) ‐ parenteral.
Salbutamol (IV dose of 0.1 mg salbutamol with further boluses every 5 minutes). N = 57.
Comparison:placebo. N = 57.
Outcomes Successful ECV, palpitations, hypotension, fetal presentation at delivery, method of delivery, perinatal morbidity, Apgar scores.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generated by a random‐number generator.
Allocation concealment (selection bias) Low risk Sealed numbered opaque envelopes prepared in blocks of 4.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label RCT and IV administration of tocolytic was not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label RCT and IV administration of tocolytic was not blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No exclusions after randomisation and no loss to follow‐up. All women received their allocated treatment.
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Unclear risk A significant difference was noted in the location of the placenta between the 2 groups. Significantly more women in the tocolysis group had a placenta attached to the fundus. Fewer women in the intervention group had a placenta in the anterior upper segment and more in the posterior upper segment, although statistical significance is not reported. It is unclear whether this would have an impact on outcomes.
Post hoc multivariate logistic regression analyses incorporating placental location and allocated treatment as independent co‐variables in the analysis with successful ECV and CS reported separately as dependent outcomes. After control for placental location in both models for successful ECV and CS salbutamol, tocolysis remained significantly associated with increased ECV success (adjusted OR 3.4; 95% CI 1.4 to 8.2; decreased CS adjusted OR 3.4; 95% CI 0.14 to 0.79).