Fetal monitoring research resources

Fetal monitoring is a controversial area.

Many women are told that their baby needs to be monitored, and yet the research shows that this doesn’t confer the benefits that people think it will.

This page brings together some of the work that has challenged the mainstream viewpoint over the years. Sadly, these challenges haven’t made much of a dent in the status quo.

There are, as always, plenty more papers and perspectives out there, so I’m not going to suggest that this is a complete list – it’s just a collection of those that I have found useful and quoted over the years.

I hope that you will find this to be a good jumping-off point, especially if you’re interested in the work of those who are questioning the use of this technology.

 

“Rubbish technology”

Midwifery Professor Paul Lewis once described electronic fetal monitoring as ‘rubbish technology’. He wrote an important article in 2013, in which he discussed the lack of robust evidence to support the notion that it is beneficial to monitor the fetal heart in labour.

Yes, not just via continuous electronic fetal monotoring (CEFM) but even via intermittent auscultation (IA), of which he says:

“…this relatively innocuous but frequent intervention may impede the natural process and progress of labour. It might be better than CTG monitoring, but that in itself is not reason enough to advocate its use.” (Lewis 2013: 386)

 

Here’s another key paragraph from that article, which deserves to be quoted in full rather than paraphrased, because I don’t think it could be said any more eloquently:

“Although CEFM is associated with a reduction in neonatal seizures compared to IA, this appeared to have no long-term significance. There are also no significant differences in cerebral palsy, infant mortality or other standard measures of neonatal wellbeing.  CEFM was, however, strongly associated with an increase in cesarean sections and instrumental vaginal births (Alfirevic et al 2007). If there are no positive benefits of CEFM in labour and clear adverse consequences, why do our guidelines continue to advocate its use, and why has it become so embodied in our practice?  The Cochrane review states that ‘the real challenge is how best to convey this uncertainty to women to enable them to make an informed choice without compromising the normality of labour’, but this clearly misses the point that the use of this ‘rubbish technology’ is itself compromising the normality of labour and birth, and the only thing that keeps it going is likely to be vested interests.’ (Lewis 2013: 386).

 

Lewis P (2013). Room 101 – The only place for fetal monitoring in labour. British Journal of Midwifery 21(6):386.

The Cochrane review referenced in the above quote was updated in 2017 and the more recent version can be found here.

 

Challenging fetal monitoring

Two 2014 papers were published in the print version of the BJOG. Both were written by obstetricians at the same London Trust (St Georges) and added further weight to the notion that we should be thinking very hard about what we are doing in this area.

 

Are we (mis)guided by current guidelines on intrapartum fetal heart rate monitoring? Case for a more physiological approach to interpretation.

“Original interpretations of fetal heart rate (FHR) patterns equated FHR decelerations with ‘fetal distress’, requiring expeditious delivery. This simplistic interpretation is still implied in our clinical guidelines despite 40 years of increasing understanding of the behaviour and regulation of the fetal cardiovascular system during labour. The physiological basis of FHR responses and adaptations to oxygen deprivation is de-emphasised, whilst generations of obstetricians and midwives are trained to focus on, and classify, the morphological appearances of decelerations into descriptive categories, with no attempt to understand how the fetus defends itself and compensates for intrapartum hypoxic ischaemic insults, or the patterns that suggest progressive loss of compensation. Consequently, there is a lack of confidence, marked variation in FHR interpretation, defensive practices, unnecessary operative interventions, and a failure to recognise abnormal FHR patterns, resulting in adverse outcomes and expensive litigation.” (Ugwumadu 2014: 1063)

This paper is detailed and it makes for really interesting reading.  Ugwumadu (2014) challenges current guidance, offers alternatives and provides much food for thought and debate.  His response to the use of the ‘DR C BRAVADO’ mnemonic which is designed to aid in the assessment of CTG tracings was that, “The user is compelled to document their assessment of the CTG features by ticking relevant boxes, but no reference is made to the evolution or progression of the FHR, the success or failure of fetal compensation, or the potential fetal consequences.  Some clinicians regard this ‘tick box’ exercise as the object of FHR interpretation.” (Ugwumadu 2014: 1064)

medium_360181859This is one of a number of areas where our understanding of physiology has grown without widespread and concomitant consideration of how our changed knowledge might be applied to practice.  While it only relates to part of the bigger question of what kinds of fetal monitoring we should be offering to women in labour, it is a welcome addition to the literature on a topic that affects so many women and babies.

The second paper is Fetal scalp blood sampling during labour: is it a useful diagnostic test or a historical test that no longer has a place in modern clinical obstetrics?

In this paper, Chandraharan (2014) unpacked the history of and evidence relating to fetal scalp blood sampling.

“Contrary to the popular belief in the UK, FSBS did not develop as an additional test of fetal wellbeing to reduce the false-positive rate of CTG. FSBS developed as a test of fetal wellbeing in its own right, used by Saling in Berlin, Germany in 1962, before commercial production of CTG machines in 1968. He took scalp blood samples from babies during labour to detect acidosis and published his series. This test, which was then developed as an alternative to CTG, was subsequently introduced in the UK, when CTG was found to have a high false-positive rate, to reduce unnecessary operative interventions.” (1056).

Probably my favourite line from this paper, and certainly the one I have most often quoted is this one:

“Current normal and abnormal values for fetal scalp pH that were recommended by the NICE Guideline Development Group on Fetal Monitoring were derived from two small studies that were performed in 1962 and 1968, without sound scientific basis.” (Chandraharan 2014: 1056)

This happens so often, and in so many areas, and it’s hard to spot where it is going on unless you have the time, skills and energy to take a deep look into the background of a subject.  Which is why it’s great when people take the time to write articles like these ones.

 

Chandraharan E (2014).  Fetal scalp blood sampling during labour: is it a useful diagnostic test or a historical test that no longer has a place in modern clinical obstetrics?  BJOG: An International Journal of Obstetrics & Gynaecology 121(9): 1056–62.

Ugwumadu A (2014). Are we (mis)guided by current guidelines on intrapartum fetal heart rate monitoring? Case for a more physiological approach to interpretation. BJOG: An International Journal of Obstetrics and Gynaecology, 121(9):1063-70.

 

The case against electronic fetal monitoring

Just weeks after the publication of the above articles, another article brought together the case against the use of electronic fetal monitoring technology.  The authors begin their paper – Cerebral Palsy Litigation: Change Course or Abandon Ship – by explaining that, in the last half-century, the response to the frequency of litigation and the increasing value of damages relating to birth-related cerebral palsy ‘was abandonment of the venerable ‘‘first do no harm’’ principle, replacing it with the expedient self-serving ethics of ‘‘do whatever is necessary to keep trial lawyers at bay.’’’ (Sartwelle & Johnston 2014)

The paper then goes on to describe the effects of this litigation and the way in which it is based on erroneous beliefs about electronic fetal monitoring:

“Electronic fetal monitoring precipitated, nurtured, and continues to be the primary cudgel against defendant physicians in the world’s courtrooms. But electronic fetal monitoring is based on 19th-century childbirth myths. Its scientific foundation is almost nonexistent. Its false positive rate exceeds 99%. It does not predict cerebral palsy.  After 40 years of continuous use and supposed improvements, electronic fetal monitoring has not reduced the cerebral palsy risk. It has, however, increased the cesarian section rate, with the expected increase in mortality and morbidity risks to mothers and babies alike.” (Sartwelle and Johnston 2014)

It gets even better, as the authors explain how a courtroom evidence rule could be used to turn this situation around.  I thoroughly recommend reading this article, as it brings together a number of key areas of evidence, and is one of the clearest and most quotable pieces I have ever read on this topic.

“It is far past time for birth-related professional organizations to confront electronic fetal monitoring reality, abandon the electronic fetal monitoring ship, and start over. Birth-related professional organizations must come to grips with the undeniable evidence that electronic fetal monitoring is an epic medical ethical dichotomy—it harms mothers and babies in direct opposition to the long-made promise not to do so. The time to act is now. If not now, when?”  (Sartwelle and Johnston 2014).

“The cardinal driver of cerebral palsy litigation is electronic fetal monitoring, which has continued unabated for 40 years. Electronic fetal monitoring, however, is based on 19th-century childbirth myths, a virtually nonexistent scientific foundation, and has a false positive rate exceeding 99%. It has not affected the incidence of cerebral palsy. Electronic fetal monitoring has, however, increased the cesarian section rate, with the expected increase in mortality and morbidity risks to mothers and babies alike. This article explains why electronic fetal monitoring remains endorsed as efficacious in the worlds’ labor rooms and courtrooms despite being such a feeble medical modality. It also reviews the reasons professional organizations have failed to condemn the use of electronic fetal monitoring in courtrooms. The failures of tort reform, special cerebral palsy courts, and damage limits to stem the escalating litigation are discussed. Finally, the authors propose using a currently available evidence rule—the Daubert doctrine that excludes ‘‘junk science’’ from the courtroom—as the beginning of the end to cerebral palsy litigation and electronic fetal monitoring’s 40-year masquerade as science.”

Sartwelle TP and Johnston JC (2014). Cerebral Palsy Litigation: Change Course or Abandon Ship.  Journal of Child Neurology.  DOI: 10.1177/0883073814543306

 

Perpetuating Myths, Fables, and Fairy Tales…

5503941553_2ce80db658“Electronic fetal monitoring (EFM) entered clinical medical practice at the same time bioethics became reality. Bioethics changed the medical ethics landscape by replacing the traditional Hippocratic benign paternalism with patient autonomy, informed consent, beneficence, and nonmaleficence. But EFM use represents the polar opposite of bioethics’ revered principles—it has been documented for half a century to be completely ineffectual, used without informed consent, and harmful to mothers and newborns alike. Despite EFM’s ethical misuse, there has been no outcry from the bioethical world. Why? This article answers that question, discussing EFM’s history and the reasons it was issued an ethics pass. And it explores the reason that even today mothers are still treated with blatant medical paternalism, deprived of autonomy and informed consent, and subjected to real medical risks under the guise that EFM is an essential safety device when in fact it is used almost solely to protect physicians and hospitals from cerebral palsy lawsuits.” (Sartwelle et al 2015).

“A half century of research in CP and EFM has exposed the myths, fables, and fairy tales forming the foundation for a continuing deceit foist upon mothers and babies by physicians and BRPOs fearful of trial lawyers—so fearful that mothers are given no choice or informed consent about EFM. This medical paternalism supposedly died decades ago, but apparently the reports of its death were greatly exaggerated. As a recent author observed, although EFM is almost certainly fatally flawed, “the overwhelming majority of laboring patients will continue to receive EFM, beneficial or not, in the foreseeable future.”

Sartwelle TP, Johnston JC and Arda B (2015). Perpetuating Myths, Fables, and Fairy Tales: A Half Century of Electronic Fetal Monitoring. The Surgery Journal, online ahead of print. DOI http://dx.doi.org/10.1055/s-0035-1567880

“EFM inventors sidestepped the scientific method and simply branded their machine a success. They failed to question the fundamental principles underlying EFM theory — the nineteenth century myth that asphyxia caused CP. Rather, influenced by twentieth century man’s newfound control over human disease, these inventors rushed EFM into widespread clinical use based on little more than anecdotes to prove their theory that EFM would reduce by half intrapartum deaths, mental retardation, and CP.

At exactly the same time, a revolution in legal theories and evidence law was taking place. Physicians confronting an exponential expansion of legal liability theories did whatever necessary to keep trial lawyers at bay. Defensive medicine appeared, and it was trial lawyers, not physicians, in charge of the decisions concerning how and when babies were born. And EFM met Murphy’s law.” Sartwelle and Johnston (2015).

Sartwelle TP and Johnston JC (2015).  Neonatal encephalopathy 2015: opportunity lost and words unspoken. The Journal of Maternal-Fetal & Neonatal Medicine, Early Online: 1–4

 

Electronic Fetal Monitoring: Rearranging The Titanic’s Deck Chairs

“EFM was introduced into clinical practice with no instruction manual, no clinical trials, with unrealistic expectations of efficacy, and without clearly defined use parameters. Fifty years of trial and error have not cured its shortcomings. By omission and blindness, BRPOs [birth-related professional organisations] have allowed trial lawyers to use EFM like a Saturday night special perpetually pointed at obstetricians and the myriad healthcare providers routinely caring for laboring mothers and their babies. The EFM gun makes every potential birth the one that will result in years of litigation, multiple defendants pointing the finger of blame at each other, and the very real possibility that at the end there will be a career-damaging, headline-making jury verdict. It is little wonder, then, that most physicians view a quick cesarean-section as the only choice when the machine indicates even a slight possibility of a birth problem. Far better to choose early cesarean-section with its complications and risks for mothers and babies than to risk being sued for acting slowly. The failure of BRPOs to act has made this decisional dilemma a daily occurrence and has created an ethical nightmare for innocent care providers: birth decisions made based on fear—the fear of being sued—are neither rational nor ethical.

It is far past time for BRPOs to confront electronic fetal monitoring reality, stop rearranging the deck chairs, abandon the EFM ship, and start over. BRPOs must come to grips with the fact that EFM undeniably creates an epic medical-ethical dichotomy—it harms mother and babies, in direct opposition to the promise care providers made—first, do no harm.”

 

Sartwelle TP, Johnston JC. Cerebral Palsy and Electronic Fetal Monitoring: Rearranging The Titanic’s Deck Chairs. J Child Dev Disord. 2016, 2:1.

 

The undiscussed cost of electronic fetal monitoring…

“In randomised clinical trials comparing electronic monitoring with intermittent auscultation, electronic monitoring increased the risk of caesarean by 63% (relative risk=1.63, 95% confidence interval 1.29 to 2.07). This suggests that, if electronic monitoring had not been used in those 620 000 women, 240,000 fewer of them would have had caesarean deliveries.” Nelson et al (2016).

Nelson K, Sartwell T and Rouse D (2016). Electronic fetal monitoring, cerebral palsy, and caesarean section: assumptions versus evidence. BMJ 2016;355:i6405 doi: 10.1136/bmj.i6405

 

Cherry picking evidence

In 2018, two senior doctors wrote to the British Medical Journal to commend them for publishing a recent debate which highlights the way “in which the doctors supporting monitoring seem to cherry pick evidence” (Bewley and Braillon 2018).

During this debate, Peter Brocklehurst, the “principal investigator of many great obstetric trials (including INFANT, a randomised controlled trial of 47 062 women undergoing continuous electronic fetal heart rate monitoring)” (Bewley and Braillon 2018) explained that,

“As a screening test, electronic fetal monitoring performs poorly. It has a poor positive predictive value, even with computerised interpretation of the fetal heart rate. This means that most of the fetuses identified as being at risk of hypoxia are not.” (Brocklehurst 2017).

In their letter, Bewley and Braillon (2018) pointed out that “Cochrane, the International Federation of Gynecology and Obstetrics, and the National Institute for Health and Care Excellence have all said that no evidence shows that human or computerised interpretation of cardiotocographs reduces the rates of intrapartum stillbirth and cerebral palsy but does cause maternal harm. INFANT showed that adding intelligent decision support to costly and demanding cardiotocography did not improve clinical outcomes for mothers or babies.”

They offered suggestions of other approaches to screening for and dealing with fetal hypoxia: mobile resuscitation devices which enable resuscitation to be carried out without cutting the cord, and carbon monoxide breath ananlysers. While the latter may raise ethical and wider issues which need careful consideration (as has been raised by some of the people involved in human rights and childbirth groups), it is clear that we need to reconsider this technology, which has failed to live up to our hopes.

Such reconsideration will not only involve challenging beliefs. Bewley and Braillon (2018) conclude that, “Our longstanding reliance on cardiotocography shows the effect of a rigid mindset but might be related to vested interests from equipment manufacturers, plaintiff lawyers, and experts with lucrative medicolegal practices.”

Bewley S and Braillon A (2018). Electronic fetal heart rate monitoring: we need new research approaches. BMJ 2018: 360: k658.

Mullins E, Lee C and Brocklehurst P (2017). Is continuous electronic fetal monitoring useful for all women in labour? BMJ 2017: 359: j5423.

 

Continuing the electronic fetal monitoring debate

“Four centuries ago, the Catholic Church declared heliocentrism to be heretical, banned all heliocentric books, and ordered Galileo to refrain from holding, teaching, or defending heliocentric ideas. A similar effort is taking place today. It seeks to suppress debate over birth caregivers’ half-century misguided use of electronic fetal monitoring (EFM) and cesarean sections (C-sections) to allegedly prevent cerebral palsy (CP). The theory — EFM predicts CP and just-in-time C-sections and prevents CP — has caused more harm than good to mothers and babies and has resulted in decades long, worldwide EFM-CP litigation that has reached a crisis of near epidemic proportions, costing tens of millions annually.”

– Sartwelle and Johnston (2018: e23).

 

This article, the latest by Tom Sartwelle and Jim Johnston and freely available online here, tells the story behind some of the recent EFM debates in the medical literature and discusses the bias towards electronic fetal monitoring and away from critical debate of the issues and the evidence (and lack thereof) on this topic. It highlights the vested interest of those wishing to continue using and defending EFM and raises important quesions about the need to critically question the evidence and thinking that underpins maternity care.

Sartwelle TP & Johnston JC (2018). Continuous Electronic Fetal Monitoring during Labor: A Critique and a Reply to Contemporary Proponents. The Surgery Journal 4:e23–e28

 

EFM: ubiquitous yet flawed

“EFM has become a quintessential example of the perils of adopting new medical technologies without proper study of risks and benefits. Despite its ubiquity and the degree to which it is relied on for decision-making in obstetrics, EFM is a poor tool for identifying or predicting adverse neurological events in infants. Randomized trials comparing EFM with intermittent auscultation (all of which were completed by the early 1990s and not repeated because EFM has since become widely adopted) have demonstrated that EFM does not prevent adverse neonatal outcomes such as low Apgar scores, acidosis, or need for admission to the neonatal intensive care unit. It is not a surprise, therefore, that the incidence of cerebral palsy has not changed in decades among infants born at term in the developed world (1.4-1.8 per 1000 live births). In addition, there is no evidence that EFM can prevent milder neurological deficits, such as developmental delay or cognitive impairment.” (Hirsch 2019).

Another paper highlighting the ineffectiveness of electronic fetal monitoring was published in the Journal of the American Medical Association. Clinical Professor of Obstetrics and Gynecology Emmet Hirsch (2019) gave an overview of the state of practice and the lack of evidence for EFM, despite tens of trials, concluding that, “The result of EFM becoming standard practice is that physicians and hospitals, perhaps indirectly, have contributed to harming families.”

You can read the article here.

Hirsch, E (2019). “Electronic Fetal Monitoring to Prevent Fetal Brain Injury: A Ubiquitous Yet Flawed Tool.” JAMA doi:10.1001/jama.2019.8918

Does electronic fetal heart rate or CTG monitoring reduce perinatal mortality in ‘high risk’ women?

In 2019, Small et al published an interesting paper on CTG monitoring in “high risk” women.

First a bit of background. There are three things we currently know about when it comes to CTG monitoring in labour.

1. CTG monitoring doesn’t prevent perinatal death or cerebral palsy when it is used in healthy (“low risk”) labouring women.

2. CTG monitoring does increase the chance of caesarean and other interventions.

3. Despite both of these things being well grounded in robust evidence, the use of CTG monitoring is widespread.

We have long needed more evidence about the effect of CTG monitoring in women who are deemed to be at higher risk for a poor perinatal outcome. So I was delighted to see the publication of a systematic literature review and meta-analysis which looked at this very question. That is, whether cardiotocograph monitoring rather than intermittent auscultation during labour was associated with changes in perinatal mortality or cerebral palsy rates for high-risk women.

Small et al (2019) looked at nine RCTs and 26 non-experimental studies. Here’s what they found … the bold emphasis is mine:

“Meta-analysis of pooled data from RCTs in mixed- and high-risk populations found no statistically significant differences in perinatal mortality rates. The majority of non-experimental research was at critical risk of bias and should not be relied on to inform practice. Cardiotocograph monitoring during preterm labour was associated with a higher incidence of cerebral palsy.”

They conclude that, “Research evidence failed to demonstrate perinatal benefits from intrapartum cardiotocograph monitoring for women at risk for poor perinatal outcome. There is an urgent need for well-designed research to consider whether intrapartum cardiotocograph monitoring provides benefits.”

Why is CTG monitoring in preterm labour associated with a higher incidence of cerebral palsy? We don’t know. And until more people greet findings like these with openness and curiosity rather than defensiveness, we won’t find out.

It is always amazing to note how much intervention and interference in pregnancy and birth is introduced without much evidence to support it. And yet it takes a phenomenal amount of research to even begin to dismantle and discontinue practices that aren’t helpful and may be harmful. And we’re nowhere near there yet with electronic fetal monitoring. But every paper like this is another that we can discuss with colleagues, women and families, in the hope of moving to care that is more respectful, woman-centred and evidence-based.

Small KA et al (2019). Intrapartum cardiotocograph monitoring and perinatal outcomes for women at risk: Literature review. Women and Birth https://doi.org/10.1016/j.wombi.2019.10.002

 

“EFM is a waste of extremely scarce resources…”

This paper looked at the use of EFM as a means of reducing cerebral palsy (CP) in sub-Saharan Africa (SSA).

As the authors note, “CP is a significant problem in SSA where it is characteristically albeit erroneously considered synonymous with birth asphyxia, leading to the increasing use of EFM in a misguided effort to reduce perinatal morbidity and mortality.” (Johnston et al 2019).

However, their literature review again demonstrated that EFM is not beneficial.

“EFM has a 99.8% false positive rate, does not predict or prevent CP or any other neonatal neurological injury and has no proven efficacy in routine childbirth. EFM causes significant harm to mothers and babies by prompting unnecessary C-sections with all of the attendant complications of that procedure, leading to considerable risks in subsequent pregnancies including lifelong repeat C-sections with high rates of operative complications, uterine rupture, and placental abnormalities, all having a higher morbidity and mortality in SSA. Recent evidence suggests babies born by C-sections suffer an increased risk of chronic and autoimmune diseases. Additionally, while EFM use without informed consent is unethical, it may be challenging to obtain true informed consent in the SSA population.” (Johnston et al 2019)

I do love that this team always comes straight to the point. They conclude that, “EFM is a waste of extremely scarce resources while simultaneously adding another layer of useless staff training complexity as well as significant morbidity and mortality to a desperately critical situation. The authors recommend ending continuous EFM in routine pregnancies in SSA, which aligns with the Australian, Canadian, New Zealand and United Kingdom guidelines, follows recent USA recommendations, and comports with the World Health Organization Quality of Care Network goals. EFM related funding should be redirected to improve healthcare for mothers, train birth attendants, and focus on therapeutic intervention for children with CP and related neurological disorders.” (Johnston et al 2019).

Johnston JC, Sartwelle TP, Arda B & Zebenigus M (2019). Electronic Fetal Monitoring as a Remedy for Cerebral Palsy in Africa: First Do No Harm. Neurology 92 (15 Supplement)

 

“So the question is why would the BRPOs [birth-related professional organisations] of the world ignore obvious evidence of EFM harm, ignore informed consent, ignore the violation of mothers’ bioethical autonomy, and ignore the reality that most of the birth profession is lying daily to mothers and themselves about EFM  dangers and forcing mothers to undergo a medical procedure that has the potential for current and future harm?” (Sartwelle et al 2016)

 

Finally, a few of my own articles that relate to this area and which highlight important aspects of this debate.

Midwives matter more than monitors

Pinard Wisdom

 

 


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