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‘Round and ‘Round the Mulberry Bush: Yet Another Medical Device to “Save” Women in Labor

September 22nd, 2011 by avatar

The Trig Medical company has a seemingly altruistic goal in mind: to reduce the risks involved with childbirth while improving the outcome of pregnancy and lowering the overall cost of obstetrical care.  Their newest product promises nothing short of this.  The LaborPro is an ultrasound-based device created to accurately track fetal station and position upon entering the mother’s pelvis. Using GPS-like position tracking technology, the LaborPro promises to “improve the labor and delivery experience and outcomes of childbirth” by removing the “blind interpretation” of cervical dilation and fetal positioning by maternity care providers. In layman’s terms, Trig Medical believes maternity care providers are so in-adept at their clinical skills of measuring cervical dilation and fetal position and station, that they feel (another) technical device is warranted in the labor and delivery setting.  Ultimately, the LaborPro is positioned as a tool which can reduce unnecessary c-sections and improve rates of fetal and maternal morbidity and mortality (and record progress of labor minute-by-minute in case this data becomes useful in a post-birth lawsuit).

 

Sounds compelling, right?

Two studies published in the American Journal of Obstetrics & Gynecology (200(4), 2009) provided data to back the use of the LaborPro in the L&D setting.  The studies, Determination of fetal head station and position during labor: a new technique that combines ultrasound and a position-tracking system, and How reliable is the determination of cervical dilation? Comparison of vaginal examination with spatial position-tracking ruler  were conducted by Dr. Jacky Nizard et al.[1],[2] in multiple centers including sites in France, Israel and Brooklyn, NY.  Interestingly, one of the other researchers, Dr. Yoav Paltieli, is not only employed by Trig Medical, but the developer of the device. The studies were small (N=166 women, fetal position/head station study; N=188 women, cervical dilation study)and clinical examinations for study data were conducted by midwives and physicians.  The ultrasound scans were performed by midwives and midwifery students in the final stages of their training.

The condensed results of the studies are as follows:

  • mean absolute difference between vaginal exam for fetal station vs. LaborPro assessment of fetal station: of 5.5 ­+ 6.1 mm
  •  Vaginal examination head-position evaluation, within a 45° interval, complied with the LaborPro system in 35 of 87 cases (40.2%)
  • Mean error was 10.2 ± 8.4 mm and ranged from 7.5 ± 7.3 mm, when cervical dilation was > 8 cm, to 12.5 ± 8.7 mm when cervical dilation was between 6.1 and 8 cm.

Indisputably, there were differences between the LaborPro and clinician measurements of dilation, station and position, and yet, I can’t help but to ask, how significant were those differences An example, provided in the study article, is the mean difference in measurement of fetal head station between the clinician’s own estimation, and that of the LaborPro. Out of (only) 59 measurements, clinician measurements were -0.8 + 0.89 millimeters different compared to LaborPro data.  0.8 millimeters is equivalent to 0.08 centimeters…less than a tenth of a centimeter.  Can this difference in estimation of where the fetus lies in the mother’s pelvis really make a difference in clinical outcome?  Even at its worst deviation (-0.8 + 0.89) the difference between a clinician’s estimation of fetal station is +1.69 millimeters (little more than one tenth of a centimeter).  I have a hard time understanding how the knowledge of the fetus being one tenth of a station further down (or up and out of) the pelvis would actually alter clinical management of labor and birth.

“Mrs. Jones, according to the LaborPro, your baby is at negative one and nine-tenths station, rather than at o station, as we thought.  We are going to need to do a cesarean section to get this baby out, safely.”

Am I the only one who thinks this is totally ridiculous?

On a more personal note, I can imagine being a maternity care provider—a doctor or midwife—well adept at assessing a woman’s process in labor, only to be approached by a company—or hospital administration—and told, ‘your clinical assessment skills aren’t nearly as good as you think they are…you need this machine to better track your patients’ progress through labor.’  Kind of demeaning, right?

And what about the non-measurement-based indicators as to where a woman (and her baby) are in labor?  As I imagine any midwife and intuitively-geared maternity care provider will tell you, so much more than the results of a vaginal exam reveal how a woman’s labor is progressing:  her self-derived body positioning, her vocalization, her behavior, the physical sensations she reports.  Opting for more and more devices to tell us what’s going on during labor risks taking the art away from maternity care.  Do we really want to trend toward a device-driven, artless approach to attending labor and birth?

And still, aside from the above-mentioned issues is the potential intrusion of yet another device to distract care providers from tending to the woman.  I remember one sage piece of wisdom I heard during PA school again and again:  treat the patient, not the monitor (test…scan…etc.)  Investing in one more machine is tantamount to divesting in our clinical skills, our attention to the human subject before us, our concern for recorded data that might come in handy if things go poorly during a birth…we risk aiming our attentions in all the wrong places.

Maternity care providers, I urge you:  Say ‘No’ to the LaborPro.

 

Tomorrow, you will have the chance to read another assessment of the LaborPro by Melissa Vose and Asheya Hennessey, Directors of Mothers of Change for Maternity Care

 

Posted by:  Kimmelin Hull, PA, LCCE, FACCE

 

 

References:


[1] Jacky Nizard MDa, Shoshana Haberman MD, PhDc, Yoav Paltieli MD, PhDd, e, Ron Gonen MDd, Gonen Ohel MDd, Diane Nicholson CNMc and Yves Ville MD How reliable is the determination of cervical dilation? Comparison of vaginal examination with spatial position-tracking ruler  American Journal of Obstetrics and Gynecology
Volume 200, Issue 4, April 2009, Pages 402.e1-402.e4

[2] Jacky Nizard MDa, Shoshana Haberman MD, PhDc, Yoav Paltieli MD, PhDd, e, Ron Gonen MDd, Gonen Ohel MDd, Diane Nicholson CNMc and Yves Ville MD Determination of fetal head station and position during labor: a new technique that combines ultrasound and a position-tracking system.  American Journal of Obstetrics and Gynecology Volume 200, Issue 4, April 2009, Pages 402.e1-402.e4

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  1. avatar
    Abundant B’earth
    September 22nd, 2011 at 09:25 | #1

    It seems that fetal position is coming into play less and less in modern obstetrics, no matter how the determination of position is made. The art of palpation is dying. Working with the laboring woman to rotate or re-position a malpositioned baby is unheard of outside doula and midwifery circles. Either the baby slides out like butter or the motherbaby is wheeled down to the OR.

    I recently was surprised to see a resident at a teaching hospital attempt to determine position (based on vaginal exam) when a mother was already in the throes of second stage labor. She assessed Right Occiput Anterior and I commented, “that’s odd, the baby was LOP yesterday.” Baby’s head restituted to LOT during birth. I can’t imagine a machine would have made an iota of difference to this mother’s labor (though it may have read the fontanelles correctly!).

  2. September 22nd, 2011 at 09:30 | #2

    Indeed, I see the biggest risk to this is the loss of attention to the actual person (people) it is supposed to be monitoring, and the lost art of manual examination. So many basic maternity care arts (like palpation, breech delivery, etc) are lost on these new providers. Do we want technology, and not a very convincing one, to replace skills that are critical? And what about when those providers find themselves in a place without the LaborPro? I was attending a planned cesarean birth for pre-eclampsia where NOBODY on the entire L&D floor could find a working blood pressure machine. There weren’t any anywhere, and nobody could find a plain ‘ol blood pressure cuff either. This mom had a very real risk of rising blood pressure, yet the staff had become so reliant on the missing machine that they couldn’t even check this mom’s blood pressure for over two hours. I think they finally found a working machine in the OR. There are just some skills that need to be left to human hands/eyes/ears.

  3. September 22nd, 2011 at 10:57 | #3

    There is a reason why we describe medical care as both an art and a science. The same, I think, can be said for midwifery care, even if the posture with which midwives approach their patients is different. But if we continue to do away with the “art” side of things, what will we be left with? Most people I know who practice medicine of one branch or another originally pursued their career of choice due to a fascination with the science of medical care, paired with the art of caring for human beings. If we lose our artistic approach to patient care–maternity care, in this instance–we are no better than a population of robots performing tasks based on algorithms and calculations during which compassion, emotion and intuition have no place.

  4. September 22nd, 2011 at 11:12 | #4

    Reading your take on this, Kimmelin, sparked another question/comment which I hadn’t thought to ask while writing my article on the subject. These studies all assume, of course, that LaborPro is the accurate measure, and that the clinicians must be off in their measurements. If ultrasound for fetal size during pregnancy is anything to go by, it may in fact be the machine that is inaccurate and the clinicians that are accurate. A baby’s weight is easy to assess: ultrasound gives you an estimate before birth, then baby is born and you can weigh the baby. Now you can determine how accurate the measurement was. Ultrasound comes up short-handed. Similarly, a midwife or physician can palpate before birth and give an estimate of fetal size. Then baby is born and you can weigh the baby. You could compare whether an experienced clinician is more accurate than ultrasound at predicting fetal size. But, in a case like dilation and fetal head station and position, there is no external validity measure to say which is correct–the machine or the clinician. While we automatically assume the machine must be correct, in fact, the machine may be making errors, and so even the slight differences shown in these studies are rendered essentially meaningless, if we are trying to discover whether LaborPro will be more accurate than manual examination.

  5. avatar
    Judith
    September 22nd, 2011 at 17:48 | #5

    I agree with the above comments and wish to add that the last thing we need is to add more technology to the birthing room. one more item to take our attention away from the woman in labor, and her attention away from what is happening internally. we imprison her with this device, and again have a reason she needs to be on continuous monitoring, have ruptured membranes, etc. did how discouraging this could be to be constantly confronted with how little dilated you might be?!
    we need to be careful when new technology gets introduced-just look at the fetal monitor-what did it bring us? and this would contribute to the ever rising C/S rate plus what about infection rate from this invasive monitor?!just when we got away from using scalp electrodes and IUPC’s! and so goes the ever rising cost of health care without better outcomes!

  6. avatar
    Rachel
    September 22nd, 2011 at 21:55 | #6

    I can only imagine how uncomfortable that thing must be for both mother and baby. Not the way I would want to welcome my little one into the world. I realize that dilation tends to be the be all, end all for hospital delivery, but honestly, you can tell plenty about what a woman and her baby are doing simply by watching and occasionally assessing heart tones if necessary. In fact, you can probably tell more about how a woman is doing by watching her than you can by sticking anything up her vagina and messing with her cervix. There seems to be this assumption that babies won’t come out without intervention. Just a little patience would show that most babies come out just fine, without any assistance at all.

  7. September 23rd, 2011 at 09:53 | #7

    I heard about LaborPro not to long ago. Devices like this worry me because it further dehumanizes birth – and birth is a very human thing! In an effort to increase cost savings (reduce the number of hospital employees) hospitals continually become more and more reliant on devices to tell them what is happening to a patient, rather then using their eyes, ears, hands and instincts to tell them if a mother or baby needs intervention during labor. The almighty dollar is why hospitals use continual EFM, with one nurse at a desk to monitor 12 laboring mothers. In our local hospitals they have a 2-1 patient nurse ratio, however, if someone is on break that ratio drops further.

    This is also a lawsuit prevention device. “See, we used the LaborPro. She needed that intervention/c-section, etc. The machine proves it!” Again, the almighty dollar rules.

    We can only hope that doctors will step up and say they prefer to check a mother manually for dilation, baby’s position, etc. and refuse to use this unnecessary and dehumanizing machine.

  8. avatar
    Bonnie
    September 24th, 2011 at 17:00 | #8

    I watched the video and read the article and felt horror. One more machine to add to our technocracy. I am a nurse on a busy LDRP unit and struggle daily to promote the idea that birth is normal. I encourage IA over EFM, encourage mobility, position change, shower and tub, food and drink. I feel as if I’m losing the struggle to yet another birthing machine and women will easily be conned into relying on it. Birth is normal, and pregnancy is not a disease.

  9. avatar
    Jon
    September 26th, 2011 at 13:57 | #9

    I agree with the above poster, specifically with “one more machine to add to your technocracy”. Although the LaborPro does have good intentions, I can see less personal care being given to pregnant women due to it.

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