A randomized clinical trial is proposed to study the effects of electronic fetal heart rate monitoring (EFM) and fetal scalp blood sampling (FSB) versus traditional auscultation of the fetal heart rate in premature infants of very low birth weight (26-32 weeks gestation). The study will be conducted at the University of Washington and Madigan Army Hospital. The study sample will be approximately 400 singleton vertex pregnancies in early labor. The intrapartum monitoring technique will be randomly assigned to either EFM and FSB or traditional intermittent auscultation. Criteria for fetal distress and intervention have been standardized. Surviving infants will be followed until one year of age to assess development. The objectives of the study will be to analyze the effects of electronic fetal monitoring vs. traditional auscultation in infants of very low birthweight with respect to the following endpoints: (1) perinatal mortality, (2) perinatal morbidity including Apgar scores, acid-base status at birth, and frequency of intracranial hemorrhage as determined by ultrasound or CT scan, (3) maternal morbidity including rates of cesarean section, (4) infant neurological and psychomotor development to one year of age as measured by the Bayley Scale of Infant Development, (5) provider satisfaction, (6) consumer satisfaction, (7) medical decision making, and (8) cost-effectiveness analysis. Data will be analyzed at the University of Washington. The study will be sensitive enough to determine a difference in survival of 0.125 (N=141/group) and a difference in the Bayley Score of 8 (N=129/group) (Alpha=0.05, Beta=0.20). The proposed study is a comprehensive technology assessment of EFM in high risk pregnancies due to prematurity. The study is significant because risks and benefits of EFM will be analyzed in the context of potentially countervailing outcomes, such as potential differences in perinatal mortality and morbidity and differences in maternal morbidity, rates of cesarean section, costs, and consumer satisfaction. Since neurological development will be followed to one year of age, long term effects of EFM can be assessed.
