Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Initiation of standard postpartum oxytocin immediately following placenta delivery; Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery; Other: Saline Placebo

• Registration Number: NCT04632264
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-17
• Study Start: 2020-12-10
• Primary Completion: 2021-04-02
• Study Completion: 2021-09-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-placental group	Saline Placebo	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).
Post-placental group	Initiation of standard postpartum oxytocin immediately following placenta delivery	Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).
Pre-placental group	Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery	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).
Post-placental group	Saline Placebo	Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States