A failed RCT to determine the best method of delivery for very low birth weight infants

Abstract

An RCT to determine the optimum method of delivery for very low birth weight (VLBW) infants was canceled after it had been in progress for only 5 months when it was discovered that more than 40% of eligible patients were being withdrawn from the trial before randomization. A review of hospital births before the trial began suggested that the trial was held too late: that a critical shift in obstetric practice towards abdominal delivery of VLBW infants had already occurred. Obtaining patient consent to participation, which had been the main predicted problem, was not difficult.