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 CONCLUSION The original term breech trial recommendations should be withdrawn.