#5 Caesarian Section versus Vaginal Delivery for Breech Presentation – The Term Breech Trial - Evidence Based Medicine Podcast

Evidence Based Medicine Podcast

For show notes including all the results for this trial: http://www.ebmpodcast.com/breech The Term Breech Trial is one of the most important clinical trials in the history of obstetrics and has changed the way we manage breech presentation across the world. The term breech trial was as randomised controlled trial comparing planned caesarian section to planned vaginal delivery for management of breech presentation at term. 2088 pregnant women, who were presenting in a breech presentation at 37 weeks or more, were randomised to one of two groups: planned vaginal delivery OR planned caesarian section. Women were recruited from 26 different countries using 121 clinical centres. The women could either have frank breech or complete breech, but they were excluded if they had a footling presentation. Women were also excluded if they were having very large babies - They defined really big as an estimated weight of 4kg or more which is 8.8 pounds (for the Americans) Allocation was concealed and the plan would be that if they were randomised to the C-section group, they would schedule it in at anytime from 38 weeks onwards. On the day of the C-section, they would make sure the baby was still in breech, and if it had managed to move to be in cephalic presentation they would then just plan a normal vaginal delivery. About 40% of the mums where randomised at the time of labour, and so they would have been pretty quickly rushed off to get their Caesarian section after being randomised to that group. If they were randomised to the planned vaginal delivery group, they would just wait for them to labour spontaneously, unless for whatever reason they needed induction of labour and they had a whole protocol on how induction of labour was to be managed. The primary outcome was the death of the baby either during labour or in the first 28 days of life, or like really bad things happening to the baby. And there was a heap of these: birth trauma, which included subdural haematoma, intracerebral haemorrhage, spinal-cord injury, basal skull fracture and peripheral-nerve injury or clinically significant genital injury; seizures occurring at less than 24 h of age or requiring two or more drugs to control them; Apgar score of less than 4 at 5 min; cord-blood base deficit of at least 15; hypotonia for a least 2 h; stupor, decreased response to pain, or coma; intubation and ventilation for at least 24 h; tube feeding for 4 days or more; or admission to the neonatal intensive care unit for longer than 4 days. Of those assigned to C-section - 90% were actually delivered by C-section. The 10% who were delivered vaginally, did so either because they managed to turn to cephalic presentation, or they had progressed too quickly in labour that it was too late for C-section, or because the mother changed her mind last minute and decided against a C-section. Of those assigned to the planned vaginal birth - only 56% ended up delivering vaginally. The rest were delivered via C-section and the most common reason being that they just weren’t progressing in labour or the baby was too big for the pelvis. So what were the results? Well that composite primary outcome - with all the bad stuff that can happen to a new born baby, coupled with some less bad stuff - went from 5% in the planned vaginal delivery group to 1.6% in the C-section group. So there was a 3.4% decrease in what they called serious neonatal morbidity or neonatal/perinatal mortality with planned C-section over planned vaginal delivery. The number needed to treat was 30, which means for every 30 breech babies we deliver via planned C-section instead of planned vaginal delivery, we will prevent 1 bad thing happening to the baby. So let’s look at the breakdown of the components of this primary outcome: Starting with perinatal or neonatal death - this went from 1.3% with planned vaginal delivery, to 0.3% with planned C-section, so a 1% decrease in baby death with planned C-se...