Intrapartum fetal oximetry monitor studies should measure C-section rate -- FDA guidance.

INTRAPARTUM FETAL OXIMETRY STUDIES SHOULD INCLUDE CESAREAN SECTION ENDPOINT, FDA recommends in a June 14 draft guidance document on premarket approval application submissions for the devices. Describing the efficacy phase of investigational device exemption studies for intrapartum continuous monitors for fetal oxygen saturation and fetal pH, FDA says it "is an intervention study to determine whether using fetal oxygen saturation by pulse oximetry as an adjunct to fetal monitoring leads to better outcomes." The agency "suggests the evaluation of the effect of fetal pulse oximetry on the rate of C-sections performed" when the monitor detects "non-reassuring fetal heart rate patterns."