Fernandez 1997.
| Methods | RCT. | |
| Participants |
Inclusion criteria: singleton, non‐cephalic pregnancy; > 36 weeks' gestation. N = 103. Exclusion criteria: younger than 17 years of age, prior uterine surgery, ruptured membranes, placenta praevia, anomalous fetus, multiple gestation, sensitivity to terbutaline, other maternal medical complications. |
|
| Interventions |
Intervention:tocolytic: terbutaline ‐ beta stimulant (A1) ‐ parenteral. Terbutaline 0.25 mg in unlabelled insulin syringe given SQ 15 to 30 minutes before ECV attempts. Forward then backward roll attempted. N = 52. Comparison:placebo. N = 51. |
|
| Outcomes | Successful ECV; CS. | |
| Notes | Parkland Memorial Hospital, Dallas, Texas, USA. January 1994 to June 1995. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised computer tables ‐ randomisation by pharmacy using computer‐generated random sequence. |
| Allocation concealment (selection bias) | Unclear risk | No mention in article. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Terbutaline or placebo obtained from pharmacy in unlabelled syringe. Placebo was an equal volume of normal saline. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo‐controlled trial with blinding of staff. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusion of women or loss to follow‐up. Appears to be an intention‐to‐treat analysis. |
| Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
| Other bias | Low risk | With exception of maternal age, the 2 groups did not differ at baseline. Mean age for terbutaline group: 23.4. Mean age for placebo group: 25.7. |