Taking the fear out of childbirth.Despite advances in modern medicine, and sometimes even because of them, preventable disabilities such as cerebral palsy, a medical condition brought on by brain injury before, during, or shortly after birth, are still afflicting American …
Linked to the health of both the mother and child, cerebral palsy can also be caused by accidents made by doctors and nurses during the birth process.
Costing nearly $1 million to manage over a person’s lifetime, about two in every 1,000 American babies are born with the problem which results in loss of motor control and abnormal body movement – with the diagnosis sometimes only coming much later, when it’s too late to prove malpractice.
Now, there may be a way to help prevent doctors and nurses from making mistakes, giving relief to both medical practitioners and new mothers. Israel’s Birmont Medical has created a device for the continuous real-time monitoring of labor progression.
About the width of an adult’s fingernail and inserted like a tampon, Birmont’s device comes fitted with two unique cameras to record and monitor the mother and baby’s vital signs during the course of labor, up to the time when the baby’s head crowns.
With a small computer attached to the future mom’s leg, the device allows for complete freedom of movement in the labor ward, including visits to the bathroom, assures Birmont co-founder Ami Lowenstein.
The Birmont device has been tested on 60 pregnant women in Israel. By continuously monitoring the birthing process from within, Birmont prevents the need for repeated physical (digital) examinations by doctors, thereby reducing infections as well.
Three other Israeli companies have tried to make a fetal monitoring device, says Lowenstein, but none have succeeded: “There is a huge hole in the market,” he tells ISRAEL21c.
One of the problems of entering a new device into hospitals is earning the confidence of doctors and opinion leaders, and getting the insurance companies to support the new technology. Birmont is currently working in that direction.
Keeping tabs on all the vitals such as heart rate, blood pressure, and cervical dilation, the device will not only give a mother-to-be a sense of security, it will be an important tool for insurance companies to deal with malpractice suits.
It is currently difficult to diagnose less severe cases of cerebral palsy or mental retardation early, until the child has grown into a toddler – when a parent notices that their child isn’t holding its head properly or walking or talking like the other kids.
Founded six years ago in the Yozmot Granot Initiative Center, Birmont is now looking for an investor to bring the device to market in the US. The investment will be used towards a multi-center FDA clinical trial in the US, and if successful, Birmont’s monitor could be in the delivery room by as early as the end of next year.
The projected cost per unit is expected to be about $10 to $200 per delivery, depending on what the hospitals demand. Some will insist that the entire unit be disposable for sanitation purposes, driving the cost up, explains Lowenstein.
Birmont’s target market is huge: about 80 percent of all women arrive at the hospital before the baby’s head has crowned.
The company’s co-founders include a retired MIT professor Dr. Simon Cohen, a physicist from America who now lives in Israel; and Prof. Drorit Hochner, a gynecologist who heads the maternity ward at Hadassah University Hospital on Mount Scopus, where the device was tested to favorable reviews.
“I know the positive reaction of the doctors, the nurses and the women themselves,” says Lowenstein. “We are now explaining the advantages to insurance companies – about how we can save the documents we record from the birth for a period of up to 20 years, if anyone should have a claim.
“Insurance companies are careful to save the data and this is a huge advantage to them if a parent should need to sue the hospital for malpractice,” Lowenstein explains.
Most importantly, Birmont hopes to save lives and to spare families and hospitals from grief.
Sadly, when in the hospital not long ago, Lowenstein witnessed the needless death of a baby. “A [traditional] monitor of the hospital made a mistake and listened to the heart rate of the mother thinking it was the baby. The baby was under stress and the doctors and nurses didn’t know – it shows the need for such a device as ours.”