CURRENT STATUS OF THE MULTICENTER RANDOMIZED CLINICAL-TRIAL ON FETAL OXYGEN-SATURATION MONITORING IN THE UNITED-STATES

Current clinical methods of intrapartum fetal assessment are sensitive but poorly specific in detecting fetal compromise during labor. These limitations have substantially contributed to the escalating cesarean section rate which occurred in the US during the last several decades . Experimental and clinical research efforts directed towards applicat ion of the oxygen saturation monitor (pulse oximeter) to intrapartum f etal assessment have produced encouraging results. If this new method of fetal assessment is to enter the clinical arena, safety and efficac y issues must first be properly evaluated via randomized clinical tria ls. The purpose of this report is to describe the design of a multicen ter randomized clinical trial of intrapartum fetal oxygen saturation m onitoring recently begun in the US. Specific aspects of the trial, inc luding purpose, study design, sample size estimates, control and test groups, inclusion and exclusion criteria, fetal heart rate classificat ion, definition of normal fetal arterial oxygen saturation (Spo(2)), c linical management protocol, and assessment of maternal-fetal outcomes will be addressed. (C) 1997 Elsevier Science Ireland Ltd.