Comparison of the outcome of delayed versus early clamping of the umbilical cord in premature neonates- a randomised controlled trial

Abstract

Introduction: Early cord clamping (ECC) has been the usual practice in preterm neonates, predominantly to facilitate immediate resuscitation of the neonate. Delayed cord clamping (DCC) seems to be safe, associated with higher blood volumes, hematocrit, improved hemodynamic stability, lesser incidence of anemia, intraventricular hemorrhage (IVH), need for blood transfusions, without any increase in untoward effects such as lower APGAR scores, polycythemia, jaundice and respiratory distress. Although several studies have shown the beneficial effects of DCC, still there is a lot of anxiety, concern and reluctance among obstetricians to accept this practice. This is primarily due to possible interference with immediate neonatal resuscitation and active management of third stage of labour. Also there is no clear cut consensus regarding the ideal timing of DCC, especially during cesarean section. Objective: To compare the effect of delayed cord clamping ( DCC) versus early cord clamping ( ECC) on hemoglobin levels in gram% on day one of life, peak serum bilirubin levels in mg/dl attained before discharge and on adverse neonatal outcome in late premature neonates, between 34 to 36 weeks 6 days period of gestation. Methodology: Design: Randomized controlled study. Setting: KLE University’s Dr. Prabhakar Kore Hospital and Medical Research Center, Attached to Jawahar Lal Medical College, Belagavi. Subjects: 128 pregnant women delivering late premature neonates both vaginally and cesarean sections and fulfilling inclusion criteria, between May 2014 to May 2015 were allocated using computer generated randomization chart. Intervention: Subjects were randomized into two groups. In DCC (64 subjects), cord was cut after 45 seconds and in ECC (64 subjects), cord was clamped within 5 seconds. Babies delivered vaginally were placed just below the level of the introitus and during cesarean deliveries; babies were placed on sterile drapes between the mother’s legs. All babies were gently dried, stimulated, suctioning done if needed. The outcomes assessed were Hb in gm% on Day one of life, highest total and direct serum bilirubin level attained before discharge in mg/dl, APGAR score at 1 and 5 minutes, NICU admission rates, need for phototherapy for hyperbilirubinemia and neonatal mortality rate. Results: The two groups were matched in terms of demographic parameters like maternal age and parity, mechanism of onset of labour, mode of delivery, and indication for induction of labour, indication for LSCS, sex of the neonate, gestational age at delivery and birth weights. Mean hemoglobin levels in gram% on day 1 of life were significantly higher among DCC 15.66 ± 3.12 versus 14.05 ± 3.07 in ECC, p = 0.0039. There was no significant difference in mean total serum Bilirubin and mean direct serum bilirubin in (mg/dl) among DCC and ECC (7.92 ± 3.61 versus 8.03 ± 3.18, p = 0.8552) and (0.40 ± 0.198 versus 0.371 ± 0.229, p = 0.449) respectively. No significant difference was noted in phototherapy (14.10% versus 10.90% p = 0.592) and APGAR score at 1 min < 7 (59.37% versus 54.68% p = 0.592). Rate of NICU admission (23.4%) and pregnancy outcome (live birth rates) was same in both groups (p = 1). Conclusion: Delayed cord clamping upto 45 secs appears to be a safe and cost effective beneficial tool which significantly improves the hemoglobin levels in late preterm neonates. It does not cause significant risk of hyperbilirubinemia and increased risk of phototherapy, does not compromise the APGAR score at birth. This can be performed during both cesarean and vaginal delivery, with neonates placed at or below the level of introitus. Thus delayed cord clamping in late preterm neonates should be incorporated in routine practice