Monitoring fetal oxygen levels during labor does not lead to healthier newborns or reduce unnecessary Caesarean deliveries.
Previous research suggested that measuring oxygen levels in the blood of a fetus helps reduce the number of caesarean deliveries. It was thought the measurements may help doctors to understand the reasons behind abnormal heart rates.
In 2000, the U.S. Food and Drug Administration gave conditional approval for one device, called OxiFirst, which measures fetal oxygen levels during delivery and is designed to be used along with electronic tracking of the fetal heart rate.
But in Thursday’s New England Journal of Medicine, researchers concluded the device is ineffective, based on their study of 5,341 first-time mothers at 14 hospitals.
In a statement, the FDA said it was reviewing the results to decide whether to change labels on the monitors or tell hospitals about the results, adding it is unlikely to withdraw approval for OxiFirst based on only one study.
Obstetricians are still looking for a way to measure the health of a fetus during delivery.
The research was funded by the U.S. National Institute of Child Health and Human Development, part of the National Institutes of Health.