Last time we covered the INFANT trial which demonstrated no apparent benefit for “high-tech” decision support software used during childbirth. This week we look at the other end of the technology spectrum during childbirth by way of the BUMPES trial to answer the question does lying down or sitting upright during the second stage of labour with a low-dose epidural make a difference to the number of women having a normal vaginal birth?
Stories of Trials That Matter
When we think of large simple randomised trials we might think of maybe studies done in cardiovascular disease or cancer and testing one or more drug treatments. But the need for reliable evidence from large randomised trials extends across all areas of medicine and trialists have applied themselves in many areas to develop this evidence. One such area is pregnancy and childbirth.
The diagram above outlines a learning healthcare system, which can be defined as an integrated system of delivering health that learns from its own mistakes. The four stages of the learning cycle resemble a traditional learning cycle for, say, an individual learning a new skill (for example, learning to ride a bicycle) and are as follows:
We know that routine breast cancer screening is beneficial in women aged 50-70, but the effects in slightly younger and older women is still uncertain. In response to this, the AgeX trial was established in 2010 offering additional screening to women aged 47-49 and 71-73. Randomisation is by means of clusters to include women invited for screening with their counterparts who are not invited for screening at 65 of the 80 breast cancer screening centres in England.
Niacin lowers LDL cholesterol and raises HDL cholesterol. The THRIVE trial randomly assigned more than 25,000 patients with vascular disease to receive either extended-release niacin with laropiprant or matching placebo. 245 sites were located in the UK, Scandinavia and China. During a median follow-up of 3.9 years, participants randomly assigned to niacin had lower LDL cholesterol and higher HDL cholesterol compared to matching placebo in patients whose LDL cholesterol had been standardized through prior statin therapy.