Whether beneficial or not
Monday, June 6, 2011 at 1:11PM
By Jill Arnold
Here is the first and last paragraph of an editorial by a physician and consultant for Neoventa Medical in the current AJOG (June 2011).
First:
As an obstetrician, present at the dawn of intrapartum electronic fetal monitoring (EFM), I had every expectation that EFM would improve perinatal outcomes and that these effects would be validated by robust clinical trials. However, metaanalysis of the randomized controlled trials (RCTs) comparing EFM with fetal heart tone auscultation failed to show that EFM decreases the most adverse perinatal events, mortality and hypoxic neurologic injury. Whether taken individually or collectively, the published trials were simply not adequately powered for these tragic outcomes which, fortunately, are quite rare. Consequently, 4 decades after its introduction into intrapartum care, the benefits, if any, that may be attributable to EFM remain to be conclusively established.
EDIT 6/11/2011: Criticism was received that not enough of the original editorial was included in the post. Here are the next two paragraphs.
This current situation makes the study by Chen et al, potentially quite important. First, its sheer size far exceeds the preceding RCTs in aggregate. Second, unlike the earlier RCTs, this study did find that EFM use was associated with significantly reduced rates of neonatal mortality and low Apgar scores. Third, the improved survivorship of preterm fetuses receiving EFM is noteworthy because most of the previous trials focused on term or near term infants. Fourth, fewer neonatal seizures were observed in the “high-risk” group who received EFM. Finally, like the previous RCTS, EFM was associated with increased rates of operative vaginal deliveries, and cesarean section for “fetal distress.”
The authors opine that these encouraging results reflect the ability of EFM to provide “accurate and early detection of fetal acidemia” and to encourage appropriate interventions. As a retrospective cohort study rather than a prospective clinical usage trial, a post hoc, propter hoc relationship between the use of EFM and the neonatal outcomes observed cannot be absolutely determined. One could also argue that Apgar scores and/or neonatal seizures may not be adequate surrogate markers for hypoxic neurologic injury, because they can stem from numerous causes other than intrapartum oxygen deprivation. Further, birth certificates as data sources have some significant limitations. Unlike complete medical records, they do not afford a glimpse into the actual fetal heart rate (FHR) tracings to determine whether they were properly interpreted or acted on. Other possibly relevant and important details of medical care and decision making that might have affected neonatal outcomes were not available to the investigators.
Last:
Returning to the central question implicit in this study, should every parturient, regardless of risk status, and with a pregnancy of any viable gestational age, receive continuous EFM? Chen et al do not have the definitive answer and neither do I. Given the enormity of undertaking the adequately powered RCT that should been done when EFM was introduced, it is unlikely that the desired level I evidence will be available any time soon. Even if such a study were considered, that is, comparing EFM with fetal heart tone auscultation, would there be sufficient bed side work force to make it feasible? Lacking this study, and if we provisionally accept the hypothesis that EFM does improve perinatal outcomes, then the obvious corollary is to address the more frequent, possibly excessive number of obstetric interventions that accompany EFM and place many mothers at risk. Whether such interventions can be made more appropriately by making our fetal monitors more “intelligent” or by using well-studied adjunctive screening methods, or both, it behooves all who care for laboring patients to encourage work on this side of the equation as the overwhelming majority of laboring patients will continue to receive EFM, beneficial or not, in the foreseeable future.
The editorial is online, so feel free to read and comment here.
Reader Comments (30)
One step forward…two steps back. How maddening. I was checked routinely by a doppler and didn’t have to be moved from whatever position I was laboring in that felt best. If I was forced to labor in bed, hooked up to EFM, I can only imagine how quickly I would’ve been begging for pain medication and then sent down a road that often leads to a c-section.
This is not the first article criticizing continuous EFM, but perhaps one of the most straightforward physician muttered words I've heard on the subject. In my lit review for my dissertation proposal I found that the research was overwhelmingly in favor of the judicious use of EFM for all labors regardless of risk level. In nearly all of the research that I came across, the cascade effect of interventions (usually ending in an unnecessarean) due to ambiguous readings coupled with the subjective nature of reading strips from EFM far outweighed the benefits in terms of reductions of infant morbidity and mortality.
Don't get me wrong, I firmly believe in the technologies that help to alleviate poor birth outcomes, but in this case, the data stands that EFM has a place, simply not in all labors and deliveries and certainly not to be used continuously. Just my 2cents and for anyone interested, I'd be more than happy to share many, many journal articles on the topic.
What is there to say? Except maybe, dear doctors, when you continually choose your beloved interventions over our health, don't be surprised when we become not only defensive, but reluctant to use your services unless we have no other option. As far as I am concerned, you can place all the impetus for the rise in homebirths and especially unassisted births squarely in the hands of the medical profession and their insistence on using their machines that go "ping!" come hell, high water, or increased maternal mortality.
I fell victim to a C Section because the EFM malfuncioned, failed to show any heartbeat. The Obs reminded me later that 'it wasn´t worth taking chances'. My friend with a CP child said how lucky I was. I felt I had been cheated and mistreated. Could I have had a normal birth? I think so, it was my second child (first was a normal vaginal delivery) and I had an easy pregnancy. We will never know. Another statistic.
Emjaybee, couldn't have said it better!
Nice post, emjaybee!! While Big Obstetrics is busy shifting the blame for intervention-overkill onto women (we're obese, we're having babies when we're older, we frivolously sue doctors), maybe it's time for them to have a look in the mirror...
My husband and I had our first baby in the hospital and while I was laboring alone the baby's heartrate plummeted unbeknownst to us (or apparently anyone)...long story short, when the nurse finally came in to check the EFM strip and saw the decel, I was rushed in for an emergency CS. I delivered our son vaginally while being prepped but because of a fluke cord accident during my labor he suffered severe hypoxia and our little guy died the next day. I fully believe there was nothing that could have been done to save him, but EFM certainly didn't prevent the tragedy. And I do honestly wonder if a midwife with a Doppler, in constant attendance, might not have caught it sooner. (Our next baby was a high-tech hospital birth but the last two were amazings with some fabulous midwives in attendance.)
I'm a NCB supporter, a doula (in my before kids life), a homebirthing Mom and (gasp!) a L&D RN. I want the moms I care for to have the birth they desire. But above all, I want the baby to come out of their vagina. If that happens in the tub, wonderful. If that happens at home, awesome. If that happens with Pitocin and an epidural, great. So we watch and wait and let labor take it's course, but if I know that an intervention will make the difference between a section and a vaginal birth, you'd better believe I'll reccomend the intervention. Tonight I cared for a mom who had been actively laboring with ruptured membranes for 36 hours. She was 6cm and had been 6cm for 12 of those hours. She had an awesome doula and an awesome midwife and a fabulous partner. But she needed to relax and the baby needed to rotate. So she chose an epidural and five hours later pushed out her son. I don't think it would have worked out without the epidural. Do I think they are HIGHLY overused? Absolutely. But do they have a place? Definitely.
Mel, thanks for your comment. I'm so sorry for your loss.
*amazing HOMEBIRTHS* I meant. =]
It might make for a more useful discussion if you included the second paragraph:
"This current situation makes the study by Chen et al2 poten- tially quite important. First, its sheer size far exceeds the pre- ceding RCTs in aggregate. Second, unlike the earlier RCTs, this study did find that EFM use was associated with significantly reduced rates of neonatal mortality and low Apgar scores. Third, the improved survivorship of preterm fetuses receiving EFM is noteworthy because most of the previous trials focused on term or near term infants. Fourth, fewer neonatal seizures were observed in the “high-risk” group who received EFM. Finally, like the previous RCTS, EFM was associated with in- creased rates of operative vaginal deliveries, and cesarean sec- tion for “fetal distress.”
Because so many babies have decels using CEFM (even "bad" decels) and are then delivered perfectly pink and healthy, I have to conclude that the monitors don't work well technically or that decels can be a normal part of labor.
"Because so many babies have decels using CEFM (even "bad" decels) and are then delivered perfectly pink and healthy, I have to conclude that the monitors don't work well technically or that decels can be a normal part of labor."
The job of the monitors is to detect decelerations so that the care provider can be sure that the baby is getting enough oxygen. The baby doesn't normally go from perfectly healthy and oxygenated to blue and limp in minutes; that process usually takes hours, with a very set pattern of worsening decelerations the whole way. (Of course, an abruption or sudden cord accident is the exception here.) Saying that babies who are born pink and healthy is a sign that monitors don't work doesn't make logical sense. If monitors work, we would expect to see fewer, not more, blue babies.
It may be the case that monitors don't work all that well, but citing healthy, pink babies as evidence of that isn't the way to show it.
After 22 years in the business (as midwife and OB nurse) I become more and more convinced that we truly don't know what a normal fetal heart rate tracing is. A few examples...Two weeks ago, a midwife showed up at home to assess a woman in early labor. She was 3 cms. The fetal heart rate was 70...yes, 70. It took more than 30 minutes to get to the hospital. They did a stat c-section and a healthy baby with 9 - 9 apgars arrived. Just 2 weeks prior to that a baby was born with "perfect" fetal heart rate tracing that was almost dead--heart rate of 60 and nothing else. Ajpgars 1-1-2. I can give example after example just like this. We think we know what a tracing is saying, whether there's good oxygenation, etc. I'm beginning to think listening/tracing fetal heart tones and interpreting them is a pure guessing game. As far as I'm concerned, the only thing that is conclusive is the dreaded lack of variability.
Jill, you have completely distorted the message of this OB's editorial with selective quoting. You have somehow missed (and excluded from your snippet) the fact that it accompanies the largest EFM study ever done, which strongly suggests that EFM cuts the death rate in half for infants between day 1 and day 8. That it saves an enormous number of lives in births prior to 37 weeks. That it prevents neonatal seizures in high risk mothers (a finding which was stated earlier, in the Cochrane Review that is so often selectively mined for quotes). And that the reduced death rate holds true for the babies of low-risk, term mothers, not just high-risk or premature births.
Go back, re-read the editorial, and look at the accompanying study. This OB is merely saying that this current study, which is huge and quite compelling and addresses the sample size limitations acknowledged in the Cochrane Review, is showing us that if the results hold true--and there's little reason to think they wouldn't--we need to focus our attention *not* on reducing the use of EFM, but instead on continuing to use it while looking strongly at new technology that will decreasing the number of false positives and eliminate the subjectivity of reading, both factors that lead to an increase in surgical deliveries beyond the break-even point.
The fact is that many women have emergent cesareans for an unreassuring tracing, only to have babies minutes later that are seemingly completely healthy. How many healthy babies do we want to deliver surgically to be sure we get all the unhealthy ones, even though we know we will never get all of the unhealthy ones?
I wonder if the device mentioned at the end of this blurb is available, or closer to becoming available, yet:
"There are numerous reasons that one of three U.S. births now is by cesarean, but Dr. Alex Friedman blames some on an imprecise monitor strapped to laboring women. Too often, he has sliced open a mother's abdomen fearing the worst, only to pull out a pink, screaming bundle.
"Everyone knows it's a bad test," said Friedman of the Hospital of the University of Pennsylvania. "You haven't done the patient a big service by doing an unnecessary surgery."
Electronic fetal monitors record changes in the baby's heart rate, a possible sign of too little oxygen. They became a tradition - now used in 85 percent of births - years before research could prove how well they work.
Guidelines issued last summer, aiming to help doctors better interpret which tests are worrisome, acknowledge the monitors haven't reduced deaths or cerebral palsy. But they do increase the chances of a C-section. While they should be used in high-risk women, the guidelines say the low-risk could fare as well if a nurse regularly checked the baby's heart rate.
Later this year, the National Institutes of Health will begin a major study to see if adding a newer technology - a type of fetal EKG already used in Europe - to the heart-rate monitor would better identify which babies really are struggling and need rapid delivery."
http://www.physorg.com/news195126809.html
The problem of false positives is well-known. However, false negatives are extremely rare. If the monitor says your baby is in trouble, it probably is, but might not be. If the monitor says your baby is not in trouble, it's almost certainly right.
On the other hand, if you're being monitored via intermittent doppler, false negatives are more common, because a baby in distress often begins in a transient manner. It's easier to miss the distressed baby, or to wait too long for a c-section. Just as a child who is struggling in a swimming pool may well look "just fine" when you pull them out, yet common sense tells us that the same child will be in bad shape if we wait longer, a baby who is left in labor when signs of distress become apparent will often *not* be "just fine" if you continue with labor, even if they look great when you pull them out. The longer you wait, the greater the risk of hypoxia, brain damage, and death. That becomes a delicate dance on the part of the provider (OB or midwife), in trying to balance the risks and pain to the mother of a surgical intervention against the very real possibility of an intrapartum or neonatal death.
One thing to consider is that in this particular study, the difference in the number of full term mothers who had surgical deliveries (including vaginal ones) was actually quite small, whether they were on EFM or not. Yet the death rate for the babies in the EFM group was half of the rate in the non-EFM group. That indicates that ultimately, distress became apparent for most of the babies in the non-EFM group who died--but that the interventions came too late.
<<How many healthy babies do we want to deliver surgically to be sure we get all the unhealthy ones, even though we know we will never get all of the unhealthy ones? >>
That's a question that's going to have a different answer depending on which baby is yours, I suppose.
How funny. I would have posted the whole thing if I could have, which is why I linked it and encouraged everyone to read it. There is intentionally no commentary of mine accompanying the post... just grabbed first paragraph and last paragraph as an intro-conclusion teaser to go read the article.
Two cries of conspiracy here. Wow. I wish I could be as clever and deliberate as you give me credit for.
Jill, it's hardly an accusation of conspiracy to point out that your quotes and in particular emphasized bits coupled with zero reference to the significant study this is published alongside suggests you either don't understand what he's saying nor the significance of the study, or you are leaving out the meaning and study for reasons unknown to me.
That your first few commenters took the same exact understanding that your quotes also implied, and ran with it, certainly suggests that they're not reading the links and are relying on your excerpt as being true to the spirit of the original message.
Not to mention that the very title of your post shows that you think it's somehow significant that a doctor realizes not every intervention is beneficial...
"just grabbed first paragraph and last paragraph as an intro-conclusion teaser to go read the article."
Now that you know, why don't you fix it so it accurately represents what the editorial says?
The editorial lauds the publication of the largest study ever done on EFM and finds that EFM cuts the rate of early neonatal mortality in half. In contrast to the Cochrane Review on EFM, which the review author himself acknowledges is, at 37,000 participants, underpowered to determine whether EFM saves lives, this study involves more than 1,730,000 women.
If your misrepresentation of the editorial is not deliberate, surely you will promptly correct it, right?