“No robust evidence” to justify NICE’s advice to low-risk first-time mothers, says BTA patron
Professor Brian Toft OBE, Emeritus Professor of Patient Safety at Coventry University and patron of the Birth Trauma Association, has criticised the advice in the revised NICE guideline on intrapartum care released today – and warned that it could be dangerous for both mother and babies.
He says: “At present there is no robust evidence to justify NICE assuring low risk first time mothers that to give birth in a free standing midwifery unit is as safe as is a hospital. Indeed, there is evidence to suggest the contrary.
“Consequently, given the potential harm to which mothers and their babies would be exposed, if the assertion by NICE should prove to be wrong; the weight of evidence in favour of such a change in public policy ought to be irrefutable.”
Maureen Treadwell, research officer at the BTA, says: “There are plans to centralise maternity units to make the most effective use of resources. This will lead to the downgrading of many consultant units to midwife led units. It is important that woman have choice of place of birth, but this needs to be based on accurate information.”
“Every birth is different, and every woman is different. There is no one right way to give birth. Yes, a woman may be low risk and ‘advised’ to give birth in a freestanding midwifery unit – but what if her sister or friend had a horrific experience in one of these units, and therefore she prefers to give birth in a hospital? Her choice is no less valid. Will she be listened to?
“NICE says women should have choice of hospital, but advises women without risk factors to give birth in freestanding midwifery units, alongside midwifery units and home birth for non-first time mums. For most trusts, four choices is unaffordable and NICE agrees that variations will be necessary. Since non-hospital birth is deemed both ‘cheaper’ and ‘safer’, these are the services that will be commissioned. This will be unacceptable to many women and their only choice will be to pay for care in the private wing of a hospital if they can afford it.
“If reconfiguration of maternity services goes ahead in the face of warnings from lawyers, user groups and doctors, there is likely to be a significant increase in deaths and brain damage for the babies of first time mothers and significant avoidable costs for the NHS.”
Background, and notes for editors
1. Currently, information on deaths and serious morbidity from free standing midwifery units is not in the public domain although several of these units have closed on safety grounds and press reports are not infrequent:
2. Multiple clinical negligence practices have publicly criticised free standing midwife units.http://www.leighday.co.uk/Blog/May-2014/Birth-without-doctors-know-the-risks
Pattinson and Brewer commented they are receiving 50% of their cases from out of consultant unit births - a very high number given that most women give birth in hospital:
Millions are being paid in compensation:
3. At a cost of around £13 million, the Department of Health commissioned a study of the safety of birth centres and homebirth called Birthplace. Instead of a records-based investigation, this was undertaken by midwives completing separate forms on each birth. The details of births where the mother transferred to another unit because of complications would have been the most difficult to complete, yet this was the important data. There were significant data losses. Moreover, 20% of woman included in the primary analysis of consultant unit births had complications at the start of labour - the primary analysis ignored this.
When the data from units who returned more than 85% of the data was analysed and the complications group removed, the babies of first time mothers who gave birth in midwifery units had over double the rate of serious adverse outcomes.
Whilst it is a sensitive issue, it should have been recognised that there was a conflict of interest with respect to midwives working in free standing midwife units, since a poor result could have potential implications for their employment.
The Birth Trauma Association had the Birthplace study reviewed by a well published epidemiologist in Europe who described the study as 'fundamentally flawed' - the study was far too underpowered to detect the statistical significance of rare events. However, a recent study in the Netherlands found that low risk women in midwifery led care had significantly higher risks than high risk women giving birth in a hospital with doctors. (1)
There were no user groups involved such as SANDS in the Birthplace advisory Group. Consequently, important issues known to be important in many deaths such as the time taken to transfer were never properly investigated. This was an extraordinary and most basic omission.
4. When NICE analysed the data in their draft Intrapartum Guideline, they excluded a large amount of important data suggesting increased risk because it did not meet their search criteria. Their evidence suggesting no additional risk came only from research rated as ‘low’ or very low’ quality. The major flaw in nearly all of the data was that it did not accurately match the midwife led and hospital groups; it compared apples with pears. Furthermore, the data only looked at women who went to midwife led units by choice and these would tend to be women who felt they were unlikely to need to transfer in an emergency and did not want epidural – it ignored the importance of these two issues to many women (2) Moreover it ignored important evidence that suggests when you allocate women to midwifery led care as opposed to letting them choose, the advantages of midwife led care disappear. (3)
1.Perinatal mortality and severe morbidity in low and high risk term pregnancies in the Netherlands: prospective cohort study. Annemieke C C Evers et alia 25/8/2010
2. Investigating women's preferences for intrapartum care: home versus hospital births. Longworth L, Ratcliffe J, Boulton M.
3. Is the operative delivery rate in low-risk women dependent on the level of birth care? A randomised controlled trial. Bernitz S1, Rolland R, Blix E, Jacobsen M, Sjøborg K, Øian P. BJOG. 2011 Oct;118(11):1357-64. doi: 10.1111/j.1471-0528.2011.03043.x. Epub 2011 Jul 12.