Stock 1993.
| Methods | RCT. | |
| Participants | Inclusion criteria: breech presentation between 36 and 42 weeks with no contraindication to ECV. N = 63. Exclusion criteria: diabetes, heart disease, thyrotoxicosis, ruptured membranes, multiple pregnancy, uterine scar, placenta praevia, oligohydramnios, impaired fetal growth, nuchal cord, placenta praevia. | |
| Interventions |
Intervention 1:tocolytic: ritodrine ‐ beta stimulant (A1) ‐ parenteral. Group B: ritodrine 0.3 mg per minute infusion for 30 minutes and during the procedure, and placebo bolus injection. N = 21. Intervention 2:tocolytic: hexoprenaline ‐ beta stimulant (A1) ‐ parenteral. Group C: placebo infusion and hexoprenaline 10 micrograms bolus injection. N = 21. Comparison:placebo. Group A: placebo infusion and bolus injection. N = 21. For the purposes of this review, which addresses the effectiveness of IV tocolysis for ECV rather than the evaluation of specific tocolytic agents, intervention 1 (group B) and intervention 2 (group C) have been combined. Nulliparous = 18 in tocolytic groups and 9 in placebo group. Multiparous = 24 in tocolytic groups and 12 in placebo group. We have not set up a subgroup comparison of 1 beta stimulant vs another, so the data from this study on failed ECV for ritodrine (7/21) vs hexoprenaline (5/21) are not included as a direct comparison. |
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| Outcomes | Immediate ECV success; ECV completed < 1 minute; fetal bradycardia during ECV. | |
| Notes | Improved ECV success rate with tocolysis reached statistical significance for hexoprenaline but not for ritodrine. Study authors decided not to continue the ritodrine/placebo arm of the trial to completion. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 'Each investigator had a separate randomisation sequence. These were in sets of 3 to the 3 groups, stratified for parity.' Method of randomisation not specified. |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled trial. Practitioners were blind to group allocation, as were the women. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Practitioners were blind to group allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of exclusions of loss to follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
| Other bias | High risk | No statistically significant differences between groups in terms of parity, height, age or gestation at time of ECV (see Table 2 on page 266). No differences between groups regarding fetal biparietal diameter, abdominal circumference. Femur length or AFI. Women in ritodrine group were significantly lighter than those in the other 2 groups. Trial stopped early for benefit. |