New System May Help Babies Avoid Brain Damage

"The umbilical cord, the brain and the heart are the particular aspects of the fetus that have to be conserved almost at all costs to maintain life," says Dr. Lawrence D. Devoe, Brooks Professor and chair of the MCG Department of Obstetrics and Gynecology. "When you start seeing changes in the heart that suggest an oxygen deficit, such as elevations in the ST segment, that means your ability to handle an overall lack of oxygen has been exceeded and your defenses are beginning to crumble."

Dr. Devoe is a principal investigator on the study of a device that combines this ST segment monitoring – which also is measured in an electrocardiogram, or ECG, – with the standard fetal heart rate monitoring performed on 80 to 90 percent of the 3.2 million babies exposed to labor in the United States each year.

Typical heart rate monitoring includes putting an ultrasound unit on the mother's abdomen or an electrode on the baby's head via the vagina to pick up fetal heartbeat, which is translated into a pattern. Although obstetricians know certain heart rate patterns indicate stress, "it's a pretty big leap from seeing these patterns to knowing for sure that oxygen delivery to the baby's brain is being interfered with," Dr. Devoe says. In fact, about half the time doctors see the abnormal heart rate, the baby is in no immediate danger.

Heart rate monitoring alone also can provide a horribly false sense of security. "A baby that is stressed early on would raise his heart rate," Dr. Devoe says. "But as the stress period becomes more intense, the baby's ability to sustain that heart rate goes down. It's like a runner. Initially, your heart rate goes up because you are trying to deliver more oxygen, but you may reach a point where you hit a wall and you can't do it anymore."

The STAN S21 Fetal Heart Monitor system®, designed by Sweden-based Neoventa, Inc., now under study in some 800 labors in the United States, seems to take some of the educated guesswork out of whether there is a real problem and helps physicians make better decisions quicker, Dr. Devoe says.

Previous studies during about 8,000 labors in England and Sweden found a 50 percent reduction in babies born with abnormal blood gasses, a 20 percent reduction in unnecessary C-sections and no hypoxic brain damage in babies monitored during labor with the device.

"When you get heart rate patterns where the condition of the baby is uncertain, your options are to continue to watch that pattern and see if it gets worse or go ahead and get the baby delivered now," Dr. Devoe says. "But when you add the ECG information, that can tell you early enough in the game that this heart rate pattern you are watching, not only is not going to get better, but the conditions that are producing it suggest that the chances of getting the (healthiest) baby mean you go now.

"This is really the first practical breakthrough in moving the field of monitoring to the next level, that is helping the precision of the tool and helping people who use it to make better clinical decisions," Dr. Devoe says.

Part of that help comes in an intense learning and certification process to ensure that investigators studying it – and one day any doctor using it – are getting optimal information to help them make critical decisions. Dr. Devoe worked with Neoventa on the U.S. version of the educational program.

U.S. studies of the device are not randomized, as are many trials. With parental consent, the device is being used in pregnancies at least 36 weeks along, with the baby pointed head first and where there is enough concern to place an electrode on his head rather than monitor heart rate via the mother's abdomen. Dr. Devoe classifies these labors at the "higher end of risk." Forty percent to 50 percent of babies born at a referral center such as MCG Medical Center would qualify for the study, although he suspects the monitor may one day be used in most labor processes. "What we are looking at here is translatability of a system that has already been tested and proven in other countries," Dr. Devoe says.