Five years to the term breech trial: the rise and fall of a randomized controlled trial.

OBJECTIVE: On the basis of the end points of neonatal morbidity and death, the authors of the term breech trial concluded unequivocally that cesarean delivery was safer for breech babies.

STUDY DESIGN: Analysis of the original and new data gives rise to serious concerns as far as study design, methods, and conclusions are concerned. In a substantial number of cases, there was a lack of adherence to the inclusion criteria. There was a large interinstitutional variation of standard of care; inadequate methods of antepartum and intrapartum fetal assessment were used, and a large proportion of women were recruited during active labor. In many instances of planned vaginal delivery, there was no attendance of a clinician with adequate expertise.

RESULTS: Most cases of neonatal death and morbidity in the term breech trial cannot be attributed to the mode of delivery. Moreover, analysis of outcome after 2 years has shown no difference between vaginal and abdominal deliveries of breech babies.

CONCLUSION: The original term breech trial recommendations should be withdrawn.