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

El‐Sayed 2004.

Methods RCT ‐ with cross‐over for some unsuccessful ECVs.
Participants Inclusion criteria: term singleton pregnancy with breech presentation. N = 59.
Exclusion criteria: Maternal exclusion criteria included chronic hypertension, preeclampsia, placental abruption, placenta praevia, maternal cardiac disease, chorioamnionitis and previous uterine surgery.
Fetal exclusion criteria included ruptured membranes, IUGR (EFW < 10th centile for GA by US), decreased AFI or oligohydramnios, fetal anomalies incompatible with life and an extended fetal head.
Interventions Intervention:tocolytic: nitroglycerine ‐ nitric oxide donor (A3) ‐ parenteral.
IV nitroglycerin (100 μg IV × 2). N = 30.
Comparison:tocolytic: terbutaline ‐ beta stimulant (A1) ‐ parenteral.
Terbutaline (0.25 mg SQ). N = 29.
After successful ECV, the decision to induce then or wait for spontaneous labour was left to the doctor. After failed ECV, the options were intervention with the other drug in the trial, discharge with appointment for CS or immediate CS; the decision was left to the doctor.
Outcomes Successful ECV; difficult ECV; palpitations; headaches; method of delivery; light‐headedness; flushing; reversion (back to breech after ECV).
Notes We have used only data on initial "Failed ECV" because of the cross‐over element of this study. We are contacting study authors to clarify the other outcome data.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation done by a third party not involved in the trial. 30 labels bearing the word 'nitroglycerin' and 30 labels bearing the word 'terbutaline.' Labels were placed on 60 unmarked opaque envelopes, which were sealed, shuffled thoroughly and numbered sequentially.
Allocation concealment (selection bias) Low risk Labels were placed on 60 unmarked opaque envelopes, which were sealed and numbered sequentially.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding of participant or doctor. Differing routes of administration of drugs, IV or SQ, meant that people would know which drug was being administered.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Unclear whether the assessor was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1 woman was assigned to terbutaline before it was confirmed that the baby was breech; excluded as fetus had a cephalic presentation. This was considered insufficient to influence the analysis.
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Low risk No statistically significant differences in pretreatment maternal or fetal characteristics (see Table 1, on p 2053). These were maternal age, GA at ECV, multiparity, EFW,  body mass index, anterior placenta and ECV by maternal‐fetal medicine attending.