[HeartsOpenWide]

Don't laboring women have enough tubes, straps, and drugs already?

FDA Clears Computerized Labor Monitoring System

By Lee Barnhart, MD Buyline Clinical Analyst



Barnev, Inc. announced that the U.S. FDA has cleared the company's new computerized labor monitoring system, the CLM, for use in the active stage of labor. The device continuously measures cervical dilation and fetal head station. These measurements are displayed real time both numerically and graphically, enabling the medical team to act based on timely information.



Traditionally, monitoring the progress of labor must be done through intrusive and repeated manual examinations. Measurements are generally obtained every one to four hours by inserting the fingers towards the cervix. Measured by finger-lengths and not objective measurements, multiple examinations even by the same person often provide varied results. These uncomfortable examinations also increase stress and anxiety for birthing mothers while increasing health risks. The CLM automates and objectifies the examination process, giving labor teams the accurate real-time information. Signals from disposable sensors located on the maternal cervix and fetal head provide objective, continuous and accurate cervical dilatation and fetal head descent data, reducing the need for frequent vaginal examinations.



The underlying concept behind CLM is the use of ultrasound technology to calculate the distance between sensors. The CLM system monitors cervical dilation by transmitting ultrasonic waves from transducers (placed on the abdomen) to receivers affixed safely and painlessly to the mother's cervix. Thus cervical dilation is monitored continuously. Similarly, sensors affixed to the fetal crown and at external anatomical locations enable accurate monitoring of fetal head descent. In most hospitals, the attachment of an ECG electrode to the crown of the baby's head (as soon as it is accessible) is a standard practice.



The company is confident that the CLM will help obstetricians and midwives make truly informed decisions during labor, expedite their decision making process and potentially reduce the various risks of delivery resulting in significantly improved medical care, as well as a reduction in costs. In addition, use of the CLM can potentially lower the cost of malpractice, a common concern in the medical profession. The data collected by the CLM could be introduced in litigation, should such a situation arise.



Barnev marked the official launch of the CLM at the 27th Annual Meeting of the Society for Maternal-Fetal Medicine (SMFM) meeting on February 7, 2007.

[RNLaborNurse4U]

Oh great, yet another piece of equipment to strap onto a woman in labor.

[LizzyL&DRN]

Doubtful the hospitals will spend the money for this new system. It sounds awful! I don't think experienced nurses are really that far off when checking cervical dilation and station. The only thing that matters is 10 anyway right??? When the head is crowning I don't need some fancy new internal to tell me its time to have a baby. I will be suprised if this system ever makes it to the floor.

[happybunny1970]

Good grief... like I need another piece of machinery strapped to me to have a normal delivery without complications...

It's one of those things that objectively sounds like a good idea, but has little practical worth. I mean, unless you are strapping it on to one of those freak mothers that come in in active labor, immediately get an epidural, and fall asleep in the bed who have to be woken up to push...

[2curlygirls]

I mean, unless you are strapping it on to one of those freak mothers that come in in active labor, immediately get an epidural, and fall asleep in the bed who have to be woken up to push...

Is there something wrong with this?

[fins]

Well, it has two advantages.

First, it provides continuous monitoring, instead of the episodic monitoring of cervical exams.

Second, it doesn't involve having someone repeatedly shove her fingers up your vagina to measure your cervix. It's something that L&D nurses do every day, so you may have forgotten just how disquieting it is to have done to you. But I know my wife just cringed every time a nurse came in to do an exam. She's a grownup, so she didn't say anything to anyone (but me), but I promise you, if you had offered her the option of "strapping on another piece of equipment" so that she didn't have to go through that, she'd have accepted.

[ukstudent]

So someone has to place the internal sensors onto the cervix and then rupture the membrains in order to place a sensor onto the baby. At which time the clock will be ticking down for a vag deliver, after which it will be a c-section. Then if she does deliver in the time limit someone has to go back in and retrieve the sensors placed on the cervix. At least I assume they don't just leave them, however that was not mentioned. I think if I have anymore children I will say no to this and allow my nurse to look after me.

[ragingmomster]

[quote=2curlygirls;2284709]I mean, unless you are strapping it on to one of those freak mothers that come in in active labor, immediately get an epidural, and fall asleep in the bed who have to be woken up to push...

You would wake her up? I'd just let her sleep until the baby fell out or she woke up and asked "what's that?" LOL

[Jolie]

Originally Posted by fins

Well, it has two advantages.

First, it provides continuous monitoring, instead of the episodic monitoring of cervical exams.

Second, it doesn't involve having someone repeatedly shove her fingers up your vagina to measure your cervix. It's something that L&D nurses do every day, so you may have forgotten just how disquieting it is to have done to you. But I know my wife just cringed every time a nurse came in to do an exam. She's a grownup, so she didn't say anything to anyone (but me), but I promise you, if you had offered her the option of "strapping on another piece of equipment" so that she didn't have to go through that, she'd have accepted.

Having experienced resistant pre-term labor with both of my pregnancies, I see a possible use for this technology in monitoring the cervical dilation of PTL patients. I began contracting and dilating at 23 weeks. I was on bedrest, home monitoring (on the rare occasions I was allowed to go home), and a slew of meds intended to keep the contractions "under control". At times, my contractions escalated for no apparent reason, and there was always the worry that my cervix was dilating as well. (Sometimes it was, sometimes it wasn't). But the only way to monitor that was by repeated vaginal exams which were terribly uncomfortable, increased infection risk (even with membranes intact), and may have contributed to further uterine irritability and further cervical dilation (a vicious circle).

If only the cervical sensor was placed, membranes would not have to be ruptured, and it would be possible to have a reliable monitor of cervical dilation. I see that as a real plus to the management of PTL.

I would be interested to hear if it is being used anywhere for this purpose, and how successful it is.

[Kiwimid]

oh my goodness, what a stupid idea. even in the case of preterm labour wouldnt it agreevate the cervix/uteris? it just doesnt sound right. I went from about 3 cms to 10 in an hour and would it detect cervical lips? i can see a million reasons why you wouldnt just it and about a handful to why you would.