Weiniger 2010.
Methods | RCT. | |
Participants |
Inclusion criteria: Healthy multiparae at term requesting ECV for breech presentation, without fetal or uterine anomaly, were enrolled after written informed consent, and all eligible multiparae requesting ECV after 37 weeks' gestation were approached for recruitment before the ECV. ASA status I to II, 37 to 40 complete weeks' gestation, no fetal abnormality (including IUGR), no contraindication for vaginal delivery or no contraindication for regional analgesia. N = 64. Exclusion criteria: previous CS, previous myomectomy with uterine cavity penetration or uterine anomaly, morbid obesity (body mass index 40 kg/m2), AFI 7 cm, neuropathy, severe back pain with radicular radiation, patient refusal of regional analgesia, poor communication or request for elective CS (after failed ECV at another institution or not wishing to attempt ECV). |
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Interventions |
Intervention:regional analgesia (C) + tocolytic. Spinal analgesia (bupivacaine 7.5 mg). N = 31. Comparison: no regional analgesia + tocolytic. N = 33. Ritodrine (50 mg IV) used as muscle relaxant until April 2003, when it was replaced by nifedipine (20 mg orally). |
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Outcomes | Successful ECV. | |
Notes | 1 woman's data not analysed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "...concealed cards allocated at random by a physician not involved in study enrolment..." |
Allocation concealment (selection bias) | Unclear risk | "Women were randomised using numbered sealed envelopes containing concealed cards allocated at random by a physician not involved in study enrolment". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The 2 experienced ECV‐performing obstetricians were not blinded. Women could not be blinded either |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding attempted |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 woman (in analgesia group) refused ECV after randomisation. 1 woman randomly assigned to receive spinal analgesia did not receive the intended treatment, as the anaesthetist was unable to locate the dura (her ECV was unsuccessful, but she was analysed as intention‐to‐treat in the spinal analgesia group) 2 women with breech presentation in consecutive pregnancies were enrolled twice in the current study. A further analysis without these women was performed to exclude potential bias for the primary outcome. The success of ECV with spinal analgesia excluding the repeat data was 23 of 27 (85.1%) vs 19 of 33 (57.5%) without analgesia (P value < 0.02) None of this would be sufficient to have an impact on the analysis |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Unclear risk | Similar maternal age, GA, weight at time of ECV and height. Similar too in terms of breech in past pregnancy, EFW, AFI. Study authors report there was no difference according to parity in the rate of successful ECV within intention‐to‐treat groups. However, it should be noted that for parity 1, 13 were included in the spinal analgesia group and 21 in the no analgesia group. |