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

December 28, 2021 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-placental group
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
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
Other: Saline Placebo
Saline placebo will be initiated post placenta delivery (within 15 seconds).
Other: Saline Placebo
Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).
Other: Post-placental group
Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).
Other: Saline Placebo
Saline placebo will be initiated post placenta delivery (within 15 seconds).
Other: Saline Placebo
Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).
Other: Initiation 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Stephanie E. Purish, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Actual)

April 2, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS9154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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