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An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

NCT02410655 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-07-31

No results posted yet for this study

Summary

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

Conditions

  • Uterine Atony
  • Postpartum Hemorrhage

Interventions

DRUG

Oxytocin

500 mL bag of oxytocin (30 IU / 500 mL) to be connected to the IV, and controlled at the obstetricians request. Up to two, 50 mL rapid infusion boluses to be given after delivery of anterior shoulder. Upon completing the bolus(es) flow rate should be continued at 100 mL / hour. This should total no more than 4.5 hours.

DRUG

Oxytocin

A total of two 1000 mL bags of oxytocin (20 IU/ 1000 mL) are to be connected to the IV sequentially, and controlled at the obstetricians request, are each to be administered over 8 hours after delivery of anterior shoulder in vaginal delivery. This will total 16 hours of oxytocin infusion.

Sponsors & Collaborators

Principal Investigators

  • Violetta Lozovyy, MD · Lutheran Medical Center

  • Jade King, BS · Lutheran Medical Center

  • Roulhac D Toledano, MD, PhD · Lutheran Medical Center

  • Kevin Fitzpatrick, MD · Lutheran Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-07-27
Completion
2017-07-27

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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 NCT02410655 on ClinicalTrials.gov