Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.
The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
104
The intervention is to determine if initiating oxytocin as soon as the fetus is delivered decreased postpartum blood loss. 30 units in 500 milliliters of 0.9% sodium chloride
Standard of care includes oxytocin administration post-delivery regardless of delivery mode. This is the comparative group. 30 units in 500 milliliters of 0.9% sodium chloride
Saline placebo will be initiated post placenta delivery (within 15 seconds).
Columbia University Irving Medical Center
New York, New York, United States
Change in Hemoglobin
Change defined as greater or equal to 1.0 g/dL (≥ 1 standard deviation (SD)) hemoglobin drop between the two arms following a vaginal delivery and greater or equal to 0.9 g/dL (≥ 1SD) following a cesarean delivery.
Time frame: Up to 24 hours
Cumulative Maternal Adverse Outcomes
Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia.
Time frame: Postpartum, Up to 6 weeks
Cumulative Neonatal Adverse Outcomes
Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality.
Time frame: Post Delivery, Up to 6 weeks
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Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).