Fetal Blood Oxygen Monitor Found Ineffective

The fetal pulse oximeter was used at every birth in conjunction with a fetal heart-rate monitoring device. In half of the deliveries, the physicians did not read the information produced by the oximeter. The researchers found that there was no difference in the cesarean section (c-section) rates or the infants' health outcomes between the deliveries in which physicians did read the oximeter data and those during which they did not. The researchers had originally planned to enroll 10,000 women in the study, but decided to stop it earlier than intended after it became apparent that the information from the oximeter "was not helping anybody.”

The fetal pulse oximeter used in the study was produced by Nellcor (Pleasanton, CA, USA).

"It's important that we found out now that this is a technology which does not appear to provide any meaningful benefit to mothers or babies,” said lead author Dr. Steven Bloom, chair of obstetrics and gynecology at Southwestern Medical Center. "We had hoped it would serve as an important adjunct or additional tool for obstetricians to use to assess the health of a baby during labor, but we didn't quite find that.”

The U.S. Food and Drug Administration (FDA) approved the fetal pulse oximeter on the condition that Nellcor would conduct further research on its use and effectiveness. However, due to lack of interest, the company discontinued production of the monitor in January 2006.



Related Links:
University of Texas Southwestern Medical Center
Nellcor