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

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.

Pelvic Measurements
And yet 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 babys 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 datawhich 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

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