Is Computerized Labor Monitoring the Future of Labor Assessment?

All women who have given birth with a birth attendant present are familiar with the standard method for determining cervical dilation and position of the baby's head during labor: a manual vaginal exam every 1-4 hours until the child is born. However, there is a new piece of equipment on the market which may change hospital labor monitoring as we know it.

In 2001, an Israeli obstetrician decided that with all the technology available for childbirth, there had to be a way to create a machine that would accurately determine the same factors as a vaginal exam¹. In 2007, he and his team finally received FDA approval for the "Barnev Computerized Labor Monitor" (CLM for short) in the active stage of labor, and began marketing it to hospitals across the USA².

The CLM equipment consists of a doppler placed on the abdomen, two censors attached to the cervix, and one sensor attached to the baby's scalp. The information is then displayed on easy to read screens next the patient's bed and in the nurse's station.

According to the Barnev company, over 300 women participated in a trial of the CLM, resulting in the following alleged benefits: a faster, simpler, and less painful way to determine cervical dilation and fetal position, freedom to use Pitocin or an Epidural, freedom to have a 'natural' childbirth, quicker treatment of fetal distress, CPD, failure to progress, and other labor complications³. Other reported benefits include cost effective management of labor, a legitimate defense for care providers experiencing lawsuits⁴, less unnecessary cesarean sections, forceps and vacuum extractions⁵.

What the press releases have not stated is that there are moderate risks involved with the CLM, as classified by the FDA. These risks include: patient injury, electrical hazards, ultrasound tissue damage, electromagnetic interference and electrostatic discharge hazards, mismanagement of patient, adverse tissue reaction, and infection⁶.

Other considerations that have not been discussed include the risk associated with rupturing the membranes, which is necessary to insert the electrode into the baby's scalp, the potential for increased discomfort, and intervention if the CLM restricts the patient to her hospital bed. It is necessary for further studies in these areas to be conducted before the CLM can be freely used on all women.

In fact, some of the midwives originally involved in the CLM clinical study were removed from the program because of their strong hesitancy in such use of technology. One of the midwives told Midwifery Today that she believes "this product takes advantage of and potentially harms women and their babies in labor, all for the purpose of economically profiting a biotech company"⁷.

Although computerized labor monitors offer many benefits, use of manual vaginal examination still gives all necessary information to the care provider. Together with the lack of studies necessary for appropriate use of CLM, it may be wise for women to temporarily question its use when the equipment comes to their hospital.

Sources:
1 - Article by Avi Hein. Feb 14, 2007. www.stepstrategy.net/artman/publish/article_2687.shtml
2, 3 - Barnev, Inc. www.barnev.com/?CatagoryID=163
4 - www.obgyn.net/fetal-monitoring.asp?page=/news/computerized_labor_monitoring
5 - www.trigmed.com/index.php
6 - "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems" U.S.D.H.H.S. Food and Drug Administration. April 24, 2007
7 - "Postdate Pregnancies". Midwifery Today E-News. Vol 8, Issue 11