Skip to main content
OpenTrials
Completed

NCT Number: NCT04632264

Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery

Other

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

Initiation of standard postpartum oxytocin immediately following placenta delivery

Other

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

Other

Saline placebo will be initiated post placenta delivery (within 15 seconds).

Primary outcomes

  1. Change in Hemoglobin

    Time frame: 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 outcomes

  1. Cumulative Maternal Adverse Outcomes

    Time frame: Postpartum, Up to 6 weeks

    Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia.

  2. Cumulative Neonatal Adverse Outcomes

    Time frame: Post Delivery, Up to 6 weeks

    Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: PROCEEDING

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2020
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.