Double blind RCT of early versus traditional oxytocin management in the third stage to prevent blood loss

Abstract

THE THIRD STAGE TO PREVENT BLOOD LOSS ALBERT SCHAEFER, LAURA KLEIN, PAM WOLFE, GRETCHEN HEINDRICKS, LANCE DOWNS, DEBRA GUINN, McLeod Regional Medical Center, Florence, South Carolina, University of Colorado Health Sciences Center, Ob/Gyn, Denver, Colorado, Biostatistician, Denver, Colorado, Denver Health Medical Center, Pharmacy, Denver, Colorado, Northwest Perinatal Center and Women’s Healthcase Associates, OB-GYN, Portland, Oregon OBJECTIVE: To determine if postpartum blood loss is reduced with early administration of a standardized oxytocin infusion immediately following delivery of the anterior sholder compared to traditional management in the third stage of labor. STUDY DESIGN: Subjects were randomized to receive a standardized oxytocin infusion immediately following delivery of the infant’s anterior shoulder (early group) or following delivery of the placenta (traditional group). Infusions were double-blinded. All participants received a total of 40 units of oxytocin. The first 20 U were given over the initial 10 minutes (2000 mU/min) and the remainder administered over 50 minutes (400 mU/min). The primary outcome measure was the mean fall in hematocrit from admission to 24 hours postpartum. A sample size of 200 was required. This number was inflated to 215 based on anticipated protocol violations. RESULTS: 215 patients were randomized on admission into two groups: early group (N = 107) and traditional group (N = 108). There were 7 protocol violations (3 early vs 4 traditonal, P = .98). The groups were balanced at randomization for potential confounders including parity, prior cesareans, induction, etc. Cesareans were equally distributed between the two groups (early 17% vs.traditional 25%, P = .18) . There were no significant differences in the mean fall in hematocrit (4.9 G 3.4 vs. 5.3 G 3.9, P = .35), rate of postpartum hemorrhage (8.4% vs 7.4%, P =.81), use of adjunctive uterotonics (12.1% vs 7.4%, P = .26), blood transfusion (2 vs 2, P= 1.0) or need for invasive procedures (1 vs 2, P = 1.0). There were also no differences in the length of the third stage (10 G 13 min vs 8G 7 min, P = .51) or the rate of retained placentas (1 vs 1, P = 1.0). CONCLUSION: Early intravenous oxytocin administration for third stage management did not reduce blood loss nor increase complications in the third stage. SMFM Abstracts S69