Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery
* Other: Initiation of standard postpartum oxytocin immediately following placenta delivery
* Other: Saline Placebo
* Other: Saline Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-placental group<br>Oxytocin will be initiated immediately after delivery of the neonatal anterior shoulder (within 15 seconds). This is our intervention group. Saline placebo will be initiated post placenta delivery (within 15 seconds). | Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery<br>* 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<br>Other: Saline Placebo<br>* Saline placebo will be initiated post placenta delivery (within 15 seconds).<br>|
| Other: Post-placental group<br>Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds). | Other: Initiation of standard postpartum oxytocin immediately following placenta delivery<br>* 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<br>Other: Saline Placebo<br>* Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Maternal Adverse Outcomes | Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia. | Postpartum, Up to 6 weeks | 
| Cumulative Neonatal Adverse Outcomes | Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality. | Post Delivery, Up to 6 weeks |