Babies have a way of arriving in the world on their own schedule, absent physician intervention, and because of the uncertainty this can create for both mother and obstetrician, an Israeli company has developed a monitoring system that would help obstetricians determine cervical dilatation and fetal head station during the active stage of labor.

Barnev (Netanya, Israel) spent four-plus years in development on what is now its first product, reporting that its CLM (Computerized Labor Monitoring System) has received FDA clearance for marketing in the U.S.

Currently, the only way to determine dilatation and fetal head position is via vaginal examination, by insertion of the fingers toward the cervix. Such examinations, the company said are "intrusive and uncomfortable for the birthing mother and at best produce subjective data."

According to Barnev CEO Yossi Machtey, who responded to questions from Medical Device Daily via email, the CLM system "uses proprietary ultrasound technology to provide safe, continuous and accurate measurement of cervix dilatation and fetal head descent."

The system does this by reading signals from three disposable sensors that are located on the cervix and fetal head, as well as external to the mother's body.

"The underlying concept behind CLM is the use of ultrasound technology to calculate the distance between sensors," Machtey wrote. "The CLM system monitors cervical dilatation by transmitting ultrasonic waves from transducers, placed on the abdomen, to receivers affixed safely and painlessly to the mother's cervix."

Machtey said it is a "standard practice" to attach an ECG electrode to the crown of the baby's head once it becomes accessible during labor. The results of the measurements taken by the sensors is produced graphically and with numbers associated with both cervical dilatation and the station of the fetal head. The results are also presented graphically on a screen with the date and time that is part of the system.

And the device is not meant just for troubled births.

While Machtey said the design of its CLM "does not exclude any pregnancies," the FDA only gave clearance for women in the active stage of labor with dilatation of 3 cm to 7 cm and "normal fetal presentation." The FDA's clearance "does not include women with breech presentations and/or infectious diseases such as hepatitis and HIV."

Machtey also said that the data collected by the CLM "can be introduced in litigation, should such a situation arise."

Asked if this might prevent physicians from adopting the device, he said the technology "could protect them, likely more often than be used against them."

Since this is Barnev's first product, the company is currently in the final stages of recruiting a VP of marketing in the U.S., he said.

"We will focus initially on large institutions, and as confidence in the system builds, work towards the smaller and community hospitals," he said.

The company is optimistic that obstetricians will benefit from the device during the birthing process.

"A multi-center clinical trial, conducted internationally, including in the U.S., has shown the CLM to be an effective and accurate tool in monitoring the progress of labor," said Dan Farine, MD, a professor of ob/gyn at the University of Toronto and head of Barnev's medical advisory board.

Farine continued, "We are 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."

Barnev, founded in 1998, is a Delaware corporation with its R&D facility in Israel. The company is exclusively focused on medical devices in the area of obstetrics.