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LaborPro: Third Generation of Monitoring Technology Promising to Improve Outcomes, Without Adequate Testing or Proven Benefit

September 23rd, 2011 by avatar

New technology claims to be a ‘breakthrough in non-invasive labor progress monitoring,’ using ultrasound and GPS-like imaging to determine pelvic diameter, cervical dilation, and the position and descent of the baby.  LaborPro claims that their advanced technology can reduce inaccuracies inherent in manual assessment of cervical dilation and fetal head station and position, and that the use of their technology will lead to fewer unnecessary cesarean sections.  Sounds great…doesn’t it?

When I heard about this technology, I got a sinking feeling. Our grandmothers had X-rays to determine pelvic diameter. Oops, that can damage the baby. Our mothers were introduced to continuous electronic fetal monitoring to make sure that babies were coping well. Oops, that has led to an increase in cesareans without improving outcomes for babies.  And now, we could be the generation that uses ultrasound and GPS to create 3D images of what is happening during labour, leading to…oops….?

LaborPro—the name sounds reassuring and promising, as if the machine has been through birth many times, like an experienced midwife. What the technology offers is so tempting…maybe clinicians would make fewer subjective decisions about labour dystocia (failure to progress) if they could SEE the baby’s head descending. Maybe they wouldn’t inaccurately assess ‘your pelvis is too small,’ if they could measure the pelvis.  And yet…

Pelvic Measurements

•    Pelvic measurements taken while lying down are different than if a woman is upright and moving. When a woman is on hands and knees her pelvic outlet is 0.5 cm bigger than when she is lying down, and movement also helps increase pelvic space. This can make a big difference to the ability of the baby to rotate and descend. Also, while measurements can be made to determine the space between the pelvic bones, the pelvis stretches during labour, and no one can predict how much it will stretch. Pelvic movement is one of the reasons labour hurts.

Optimal Positions and Movement During Labour

•    It seems (from the LaborPro video, the way that sensors are placed, and the way ultrasound is used) that women will need to be supine or semi reclining to have LaborPro applied to them.  This is the least effective position to labour in.

•     It seems that during the use of the LaborPro tool, women must be stationary, as they will have sensors attached to their body.  This is the least effective mode to labour in: it is more effective for women to move around freely during labour to encourage descent and optimal positioning of the fetus.

Ultrasound Safety & Accuracy

•    The use of routine ultrasound during pregnancy continues to be a controversial issue, especially in healthy term pregnancies.  The threshold of safe ultrasound exposure has not been established, nor has it been recently studied in an independent or academic manner. The Society of Obstetricians and Gynaecologists of Canada (SOGC), Health Canada, U.S. Federal Drug Administration, and American Institute of Ultrasound in Medicine (AIUM) all advise against the non-medical use of ultrasound, referring to concerns about tissue overheating and cavitation.

•    Particularly, an extended or repeated exposure of ultrasound to the head of an infant, which houses the brain, has not been extensively studied with regards to safety for the unborn baby.  The LaborPro is applied close to the unborn baby’s head during labour.

•    Ultrasonography measurements with regards to fetal size are notoriously inaccurate.  What makes the ultrasound machine suddenly an extremely accurate measurement of size and position?

•    What happens if the sensors slip or move during the use of LaborPro? Will this create inaccurate results, leading to unnecessary interventions?

Non-Invasive?

•    While LaborPro claims its technology is non-invasive, to determine cervical dilation, the technology still requires that clinicians insert a finger into the woman’s vagina. The difference with LaborPro is that a positioning sensor is attached to the clinician’s finger, so the technology can determine how dilated the woman is, rather than the clinician. This means women will continue to have vaginal exams and the use of technology, doubling up on the quantifying, measuring, left brained, logical, medical assessment without evidence of health benefits.

•    Labour is largely a function of the parasympathetic nervous system, particularly the dilatation phase.  Any disturbance, interference in a woman’s privacy, interruptions, or breakdown in her confidence in her ability to give birth will introduce fear into the equation.  Fear counters parasympathetic functions, and slows down labour progression.  LaborPro has the potential to disturb a woman’s concentration and the quiet peacefulness of a birth environment, interfere with her privacy by techs, physicians, or other staff entering and exiting her room more often than before or in a more disturbing manner because of the moving of equipment, and the potential to break down a woman’s confidence because of the implication that technology is a more trustworthy entity than the woman’s body or low tech approach by care providers.  Research shows the benefits of having a low tech approach encourage favourable outcomes.

Loss of Hands-on Skills and Human Touch

•    The LaborPro tool has the potential to undermine care provider hands on skills.  Research (referenced and expanded upon in Atul Gawande’s book “Better”) shows that a low tech approach costs health care systems less and results in better health for patients, regardless of which area of medicine is assessed.

•    In times of emergency (i.e. electrical blackout, fire), natural disaster (earthquake, flood etc.), and widespread lack of access to technology because of a rural environment, hands on skills are imperative. Surges in patient loads can lead to all machines or surgical suites being in use, along with a lack of technicians or physicians trained in using the technology.

•    All medical practitioners recognize the importance of good hands on skills and human touch in medicine.  Despite this, we so often look  to technology to tell us what we can determine clinically.  The use of a pulse oximeter is a great example: a patient’s pulse may be determined by palpating the radial artery and her blood oxygen concentration can be estimated by assessing her skin colour.  The oximeter is sometimes wrong, and a quick assessment is more accurate.  Good manual measurement skills will be lost if technology usurps hands on assessment via LaborPro.

•    Yes, the accuracy of measuring actual centimetres dilated varies between care providers and is subjective.  But knowing the exact number is not as important as assessing progress: is a woman more or less dilated than the last time I measured? And assessing the presence of remaining cervix: is the cervix fully dilated or not?  Exact centimetre accuracy is less important.

Add to all these concerns the fact that NONE of the clinical trials (which were most likely funded by Trig Medical, the company selling LaborPro) showed that the technology was any better than digital examination for determining dilatation, position, and station. The research sample sizes were small, and did not include any outcome data—which means it certainly does not support or even address the claim that LaborPro will reduce caesarean sections, and there is no data on whether the health of mothers and babies are improved with the technology.

One of the selling features of LaborPro is that it automatically stores data on labour—which could then be used to defend medical personnel in malpractice suits. In fact, some have suggested that this may in fact be one of the main reasons hospitals will buy this equipment.

TrigMed is on a circuit in the US, at conventions such as ACOG 2011, Birth 2011, ISUOG 2011, and RSNA 2011. They are presenting their product to obstetricians, promising results that have no academic research behind them.

I have a better idea. Instead of implementing an expensive, untried product, which will most likely lead to more problems and misdiagnoses, let us move towards a proven approach to labour and delivery: supportive one-to-one care, allowing labour to begin on its own, and patience with the birth process.   Let mothers learn to listen to their own bodies and babies, and let mothers be the ones to tell medical personnel what is happening within themselves. Let us allow nature to unfold in the way it is designed, slipping babies into the world with as little interference as possible.

 

Guest Posted by: By Melissa Vose and Asheya Hennessey, Directors, Mothers of Change for Maternity Care 

 


Fetal Monitoring, Guest Posts, Medical Interventions, Science & Sensibility , , , , , , , , , , , ,

  1. September 23rd, 2011 at 09:23 | #1

    “While LaborPro claims its technology is non-invasive, to determine cervical dilation, the technology still requires that clinicians insert a finger into the woman’s vagina.”

    You make an interesting point here, and it prompts me to ask: when exactly did our maternity care system come to equate vaginal examination as “non-invasive?” Ask any woman undergoing a vaginal exam–during labor, or at any time in her life–and she will most certainly tell you that that experience is most definitely invasive.

  2. avatar
    sara r.
    September 23rd, 2011 at 15:22 | #2

    Totally agree with Kimmelin’s comment- I was fortunate enough to avoid any vaginal exams during my birth because my daughter was crowning when we arrived at the hospital. Later, in observing a doula client endure a vaginal exam, I was absolutely struck with the invasiveness of this common “procedure”. It makes it worse when the mom has back labor and laying down is excruciating. I am pregnant again, and although my midwife has said that she would like to do a vaginal exam when we reach the birth center to check for baby’s position, I am again hoping to avoid it, even if I have to simply refuse.

    The whole concept of this machine is ridiculous, imo. Cervical dilation is simply not a good measurement tool for labor progress, in my opinion.

  3. avatar
    Reality
    September 23rd, 2011 at 16:48 | #3

    I am flummoxed by women who object to standard exams during the delivery process. They were barely noticeable over the horrible pain of the contractions, and unnoticeable after the blessed relief of the epidural.

    I’m perplexed as to your objections in the ways as to which technology can make the lives of women and emergent babies safer, especially by the outright inaccurate statement that EFM does not save babies lives, because it most certainly does. Why are you opposed to this?

  4. September 23rd, 2011 at 20:17 | #4

    I’m reminded of what my statistician supervisor used to say, along the lines of “it’s better to have an approximate answer to an exact question than the exact answer to an approximate question”. The LaborPro might (and that’s obvious a huge “might”) provide exact answers but it’s not at all obvious that they are answers to the right questions about a woman in labour.
    Sadly, the medical profession has a long history of being excited by exact answers without paying attention to the exact questions.

  5. avatar
    Sue
    September 24th, 2011 at 02:55 | #5

    Dear Author,
    I don’t know whether you are an active clinician, bit I have several issues with statements that you have made (and you have only provided two references).

    For example, you state:
    “The use of a pulse oximeter is a great example: a patient’s pulse may be determined by palpating the radial artery and her blood oxygen concentration can be estimated by assessing her skin colour.”

    Can you really support his comment. It is not true that colour reflects oxygen saturation until the patient is actually cyanosed – which represents severe hypoxia. That’s why oximetry has become standard in all the critical care areas, including anesthesia and emergency medicine. Where have you seen evidence otherwise?

    In a discussion such as this, it is important to present objective information, rather than opinion. Thanks for explaining.

  6. September 25th, 2011 at 08:43 | #6

    @Reality
    Actually, there is no current (or recent) data supporting this claim. The truth is that EFM has failed to deliver on the promise of “saving babies lives.” For excellent (up-to-date) reviews on the topic, check out the related sections in A Thinking Woman’s Guide to a Better Birth (Henci Goer) and Pushed (Jennifer Block). Also, for a comprehensive review on EFM (includes review of data from 13 RCTs on EFM) read this Cochrane Review: http://www.ncbi.nlm.nih.gov/pubmed/11405949. The gist of the Cochrane review: while there was a protective effect against neonatal seizures, there was NO reduction in: cerebral palsy, NICU admissions or perinatal death.

  7. September 26th, 2011 at 13:54 | #7

    In fact I wrote the following;
    “The use of a pulse oximeter is a great example: a patient’s pulse may be determined by palpating the radial artery and her blood oxygen concentration can be estimated by assessing her skin colour.”
    And as a clinician my statement was an example of how over reliance on technology can cause a loss of clinical skills. Skin colour and quality assessments are actually fairly accurate if combined with other observations or measurements, depending upon what one is using oximetry for. Often paramedics, nurses, and physicians will skip manual assessment of the pulse and skin condition and rely solely on the oximeter. If a patient’s extremities are cold, dirty, in tonic clonic muscle contractions during a seizure, or etcetera, the oxygen saturation that shows on the oximeter is quite frequently lower than actual oxygen saturation.

    My intent was not to suggest that a pulse oximeter not be utilized, but rather that it be combined with retained clinical skills to provide the most accurate assessments and the most optimal patient care. In certain cases exact percentage oxygen saturation is valuable to know (respiratory failure, etc), and in certain cases manual pulse rates are impractical (during transfers between beds, etc). However the complete reliance on technological tools will result in the loss of hands on clinical skills and a loss of trust in clinical observation as a trustworthy tool in medicine.
    If a patient is in respiratory arrest, is pale, cool, and clammy, with cyanosis on the nail beds, I do not need a pluse oximeter. My eyes and touch will tell me what I need to know, and faster than the pulse oximeter. This was my intended message in using pulse oximetry as an example of when technology and hands on skills intersect. My point was simply that clinical skills are important to retain, and that clinical observations can be relied on more heavily than technological measurements.
    I hope this clarifies my use of the pulse oximeter as an example.

  1. May 22nd, 2012 at 23:15 | #1