Dugoff 1999.
Methods | RCT. | |
Participants |
Inclusion criteria: breech presentation, 36 weeks or more, reactive CTG, intact membranes, minimum 2 × 2 cm pocket of amniotic fluid. N = 102 in the main paper (in abstract, reported as 101 women). Exclusion criteria: gross fetal anomaly, uterine malformation, EFW > 4000 g, fetal growth restriction, placenta praevia, third‐trimester vaginal bleeding, labour, contraindications to spinal analgesia or terbutaline. |
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Interventions |
Intervention:regional analgesia (C) + tocolytic. Spinal analgesia with 10 mcg sufentanil and 1 mL 0.25% bupivacaine and 500 mL lactated Ringer's prehydration. N = 50 (49 in abstract; we will use detail from the detailed publication) Comparison:standard care + tocolytic. N = 52. ECV with terbutaline 0.25 mg was attempted usually by 2 operators, and was stopped for fetal bradycardia, maternal discomfort. Up to 4 attempts were allowed. Vaginal elevation of the presenting part not used. |
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Outcomes | Successful ECV; breech delivery; CS. | |
Notes | University of Colorado Health Sciences Centre and Denver Health Medical Centre, USA. October 1993 to August 1997. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, computer‐generated sequence. |
Allocation concealment (selection bias) | Unclear risk | Allocation by cards in sealed envelopes. Cards designating "spinal" or "no spinal" were placed in sealed opaque envelopes that were opened after women signed informed consent forms. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Likely that the women and the clinician were not blinded to whether or not women received an epidural. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of whether investigators were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Spontaneous version occurred before ECV in 4 women in the spinal group (after the spinal was given) and in 1 woman in the no spinal group. These women were included in the intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Low risk | No differences in baseline characteristics were noted. |