A well conducted RCT has not shown the expected 30% drop in stillbirth and many commentators are suddenly ,and very dangerously ,saying that maternal awareness of fetal movements is not an important preventative factor for stillbirth.
This is nothing short of an astounding conclusion. It flies in the face of EVERYTHING we know from multiple well conducted observational and experimental studies done over many years. It doesn’t make sense and most importantly those who are using words like “harm” and “flop” in connection with this study and its findings should be ashamed of themselves as they are directly placing babies lives in danger.
As I already said the study actually does show a reduction in stillbirth, 9% …that’s NINE percent. About 77 women are holding their babies in their arms as a result of their hospital participating in this study instead of visiting their graves.
So why is this study being called a flop, and a failure?
Well its because the investigators powered their study for at least a 25% drop. That means that when they calculated how many participants they needed to show a statistically significant difference in the stillbirth rate they looked at the aforesaid studies and made their calculations based on them, no doubt thinking that a RCT design would be able to show a similar effect size. With the benefit of hindsight I hope they are now thinking it would have been far better to have taken a more modest approach. Why? Because, of course, in the meantime the cat is well and truly out of the bag. What I mean is that the information that they gave the women in the study was already in general use as was the pathway for the care-providers response. In spite of this FACT the intervention STILL worked to reduce stillbirth by 9%! Why? Because mums were made aware of the importance of fetal movements and their care-provider acted appropriately when they reported those concerns.
I often compare protecting the vulnerable baby from stillbirth to how we have protected the vulnerable baby from SIDS and this is an appropriate analogy to make again here
I’d like the naysayers of this study to imagine that someone has recently completed and reported a very large well conducted RCT published in one of the best medical journals in the world. The study was an intervention in which parents were told to place their baby to sleep on their back to prevent SIDS. The study was powered on an 80% drop in the SIDS rate (as this is the drop that has been reported following the back to sleep campaigns). The study reports that they could not replicate this drop in their RCT and that therefore placing the baby in the supine position to prevent SIDS “remains unproven”. Would there, or would their not be an outcry from the SIDS community? Wouldn’t they say there is no way such an RCT would be able to show that kind of reduction now because the information about putting your baby back to sleep is already well known? YOU BET THEY WOULD and so actually the stillbirth research community AND those whose baby’s lives have been saved as a direct result of being made aware of the importance of fetal movements need to voice their concerns in the “controversy” that CI Norman seems to be expecting and do the same
When it comes to investigating the effect of an intervention that is already well known RCTs can't possibly "prove" a concept thats already in no doubt, yet in spite of this the study showed a 9% reduction! If anything this shows that awareness IS important.
So now I am prepared to go on record and predict that when the other large randomised step wedge cluster RCT ‘my baby’s movements’ study in Australia is published it will also not show the expected drop in stillbirth and some might also call it a “flop” and a “failure”. Hopefully most of us will be smart enough to shrug and say “of course not” and move on with continuing to save baby’s lives by telling the mum about the importance of fetal movements and acting appropriately when she presents with concerns.