'Round and 'Round the Mulberry Bush: Yet Another Medical Device to "Save" Women in Labor

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).

LaborPro

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 pelvisreally 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, PhDczzz, Yoav Paltieli MD, PhDde, 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, PhDde, 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

To leave a comment, click on the Comment icon on the left side of the screen.  You must login to submit a comment.  

Recent Stories
Research Review: Waterbirth Continues to be an Appropriate Option for Low-Risk Families

Series: Building Your Birth Business - Five Reasons to Consider an Early Pregnancy Class

Causal Inference - A Better Research Method for Studying Labor & Birth?