Multicenter clinical trials of fetal pH monitoring in the U.S.A

A multicenter collaborative study of the safety and clinical efficacy of the ROCHE fetal pH monitor has been started. A common protocol and reporting forms are used. As of April, 1978, 115 case reports have been received describing results with the latest hardware. The tissue pH monitor can be relied upon to monitor pH if the values are in the normal range. Comparison of tissue pH (tpH) with 146 capillary pH samples revealed 98% accuracy of tpH in classifying normal (greater than or equal to 7.20), but false tpH acidosis occurred in 6% of normals. Therefore, acidotic tpH values must be verified. Although six infants had some degree of trauma (small lacerations), there were no serious or permanent injuries.