Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping (PROCEEDING)

Columbia University

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Other: Initiation of standard postpartum oxytocin immediately following placenta delivery; Other: Saline Placebo; Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT04632264

AAAS9154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

Pre-placental group

Experimental group

Description:

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).

Treatment:

Other: Saline Placebo

Other: Saline Placebo

Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery

Post-placental group

Other group

Description:

Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).

Treatment:

Other: Saline Placebo

Other: Saline Placebo

Other: Initiation of standard postpartum oxytocin immediately following placenta delivery