The early external cephalic version (ECV) trial: A randomised controlled trial of ECV beginning at between 34--36 weeks compared to 37--38 weeks gestation.

摘要

Background. In about 3–4% of all pregnancies at term the fetal presentation is non-cephalic. External cephalic version (ECV) at term has been shown to decrease the rate of non-cephalic presentation at birth, and to decrease the rate of Caesarean section (CS). However success rates for ECV are low. This randomised trial was done to compare the effectiveness of a policy of beginning ECV early at between 34–36 weeks gestation, and beginning ECV at 37–38 weeks gestation.; Methods. At 25 centers in seven countries, 233 women with a singleton breech fetus were randomly assigned to having ECV performed early at between 34–36 weeks, or delayed until 37–38 weeks. The primary outcome was the rate of non-cephalic presentation at birth. An intention to treat analysis was used.; Findings. Data were received for 232 women, with 116 women in each of the early and delayed ECV groups. The rate of non-cephalic presentation at birth in the early ECV group was 66/116 (56.9%) and 77/116 (66.4%) in the delayed ECV group (RR [95% CI] = 0.86 [0.70, 1.05], p = 0.09). The rate of serious fetal complications and the rate of preterm birth 37 weeks were not significantly increased in the early ECV group compared to the delayed ECV group (6.9% vs. 7.8% RR [95%CI] = 0.89 [0.36, 2.22] p = 0.69 versus 8.6% vs. 6.1% RR[95%CI] = 1.42 [0.56, 3.59] p = 0.31). The rate of CS was 75/116 (64.7%) compared with 83/116 (71.6%) in the early and delayed ECV group respectively (RR [95% CI] = 0.90 [0.76,1.08] p = 0.32). Neonatal outcomes were comparable in the two groups. In both groups, the rate of reversion to non-cephalic presentation was low and the majority of women indicated that they would consider having an ECV in another pregnancy.; Interpretation. Early ECV may reduce the incidence of non-cephalic presentation at delivery. A large pragmatic trial is required to assess this approach further in terms of CS rates and neonatal outcomes prior to recommending changes in clinical practice. In the interim, women with breech fetuses should be provided with information about ECV that includes the findings and limitations of this trial.