Postpartum Hemorrhage
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERInitiation of standard postpartum oxytocin immediately following fetal shoulder delivery
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
OTHERInitiation of standard postpartum oxytocin immediately following placenta delivery
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
OTHERSaline Placebo
Saline placebo will be initiated post placenta delivery (within 15 seconds).
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization will be achieved using a computer generated algorithm. Both patient and provider will be unaware of the allocation arm.
Intervention model description
Two parallel randomized, placebo-controlled, and double-blinded studies. For this study we will include 52 scheduled cesarean sections and 52 vaginal deliveries as two separate cohorts.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable * Scheduled cesareans * Women aged 18 years or older * Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units
Exclusion criteria
* Multifetal gestation * Placental abruption or antepartum hemorrhage * Maternal bleeding disorder * Known fetal anomaly or anemia * Fetal growth restriction with abnormal Doppler * Significant maternal anemia (pre-operative hemoglobin ≤ 7g/dL * Intrapartum stillbirth * Placenta accreta spectrum * Abnormal placentation (previa or abruption) * Planned cord blood banking * Refusal of blood products * Any contraindication for delayed cord clamping * Maternal history of aortic stenosis or pulmonary hypertension or other severe cardiac structural disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin | Up to 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Maternal Adverse Outcomes | Postpartum, Up to 6 weeks | Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia. |
| Cumulative Neonatal Adverse Outcomes | Post Delivery, Up to 6 weeks | Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality. |
Countries
United States
Outcome results
None listed