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Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

NCT04632264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

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

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

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).

Sponsors & Collaborators

Principal Investigators

  • Stephanie E. Purish, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-04-02
Completion
2021-09-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632264 on ClinicalTrials.gov