ROME, Italy — At a medical conference in southern Italy in 2006, bioengineer Sergio Casciaro asked a group of gynecologists what they used to monitor birth. One doctor replied, “We rely on the digital method.”
And “by digital,” continued the doctor, “I mean the digits that extend from my palm,” and waved his fingers in the air.
Casciaro was dumfounded. “I couldn’t believe that we still had no technology to provide objective monitoring of birth,” he said.
Attempting to fill this gap, Casciaro and his team of researchers introduced AMOLAB — Automatic Monitoring of Labor. By strapping a transducer belt over a woman’s pelvis, the device is able to transmit live images of the position and angle of the fetus up to the moment of birth.
Conceived by the scientists at the National Council of Research in their spare time, AMOLAB has already won Italy's National Innovation Award. This summer, its first clinical trials began.
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In providing continuous recorded evidence of the progression of birth, Casciaro says the 3-dimensional ultrasound instrument could discourage doctors from performing unnecessary Cesarean sections.
“If the national average of C-sections has reached 40 percent, and peaks to 65 percent in southern Italy, there must be a problem,” said Casciaro. “I think the situation is out of control.”
For decades, obstetricians and midwives have relied heavily on their own clinical intuition. They combine their expertise with a number of instruments — including their bare hands — to help monitor everything from fetal heartbeat and contractions, to the size and angle of the baby.
But these traditional tools, as shown by a recent study published in the American Journal of Obstetrics and Gynecology, expose even seasoned doctors to high margins of error.
Doctors know this, so at the sign of any complication during labor, many prefer to make an incision, rather than endanger the baby and mother or face a lawsuit.
“These days, there is definitely an excessive use of Cesarean sections,” said Dr. Gianfranco Nacci, head of Gynecology and Obstetrics at the Perrino Hospital in Brindisi, a major medical center in the heel of Italy’s boot. “This situation doesn’t only affect Italy, but all countries in the world, unfortunately even developing countries,” he said.
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Throughout the Western world, the number of C-sections performed has increased dramatically.
Since the 1980s, the World Health Organization has insisted that all countries limit Cesarean procedures to no more than 15 percent of all births. In the United States, rates have reached a national record high of 37 percent, according to a recent report by the National Center for Health Statistics.
Today in Italy, the number of babies born through C-sections has reached 38 percent. This figure has doubled in just 15 years.
This doesn't necessarily mean that the level of medical intervention in childbirth has increased. At the Perrino Hospital, where Nacci has delivered babies for 20 years, precise C-sections have replaced older and more risky procedures — such as using forceps or vacuum extractors to move a baby along the birth canal.
“But we have gone too far now,” said Nacci. “We have arrived at percentages of C-sections that have no clinical justification."
To complicate matters, doctors say patients’ expectations around natural birth have shifted, too.
“In the past, mothers were more willing to wait and labor lasted more hours,” said Laura Bruno, an obstetrician who works with Doctor Nacci at the Brindisi Hospital. “But now, some women come to the hospital expecting C-sections."
To Sergio Casciaro, however, it’s not the mothers’ expectations, but the doctors’ desire to make it home for dinner that influences the final outcome. Also, said Casciaro, in most Italian regions, hospitals can charge double fees for a C-section, which continuously tips the balance against vaginal birth.
“The ability to have tangible, solid evidence to demonstrate that they made the best decision in that scenario is what I want to provide for doctors and mothers,” said Casciaro. While C-sections certainly can save the lives of mothers and babies, the intervention also leads to a longer recovery for the mother and the possibility of other side effects.
“Right now it’s all subjective,” continued Casciaro, who thinks doctors’ discretion doesn’t always safeguard mothers during birth. However, AMOLAB could also have a benefit for doctors, providing information that would shield them from unfair lawsuits.
The AMOLAB team has registered their invention under an international patent and is now in talks with private investors to fund a leap into the commercial market.