Nor Azlin 2008.
Methods | RCT. | |
Participants | Inclusion criteria: singleton term pregnancies with a breech presentation. N = 86. Exclusion criteria: oligohydramnios, macrosomia, presence of a contraindication for vaginal delivery, previous caesarean delivery, multiple pregnancy, hypertension in pregnancy, rhesus‐negative mother, previous history of abruptio placenta, lethal fetal anomaly, contraindication against nifedipine or terbutaline. | |
Interventions |
Intervention:tocolytic: nifedipine ‐ calcium channel blocker (A2) ‐ oral. Oral nifedipine (20 mg). N = 43 (nulliparous 18, multiparous 25). Comparison:tocolytic: terbutaline ‐ beta stimulant (A1) ‐ parenteral. IV terbutaline (50 μg). N = 43 (nulliparous 21, multiparous 22) (6 lost to further follow‐up). |
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Outcomes | Successful ECV, difficult ECV, palpitations, hypotension, method of delivery, perinatal morbidity. | |
Notes | 6 successful ECVs from the terbutaline group were lost to follow‐up. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised random‐number generator. |
Allocation concealment (selection bias) | Low risk | Sealed, opaque, numbered envelopes in sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Clinicians doing ECV were blinded to the tocolytic drug, women were not blinded because 1 group had oral administration and the other IV. Clinicians doing the ECV were in control of the success rate and were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Clinicians doing ECV were blinded to the tocolytic drug, women were not blinded because 1 group had oral administration and the other IV. Clinicians doing the ECV were in control of the success rate and were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Among those who had successful ECV, 6 from terbutaline group were lost to follow‐up, so although all women were included in the assessment of the success of ECV, the outcome of CS is at risk of bias. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | The study was not stopped early. Baseline characteristics were similar between groups in maternal age, GA, AFI, parity and type of breech presentation. No other biases were identified. |