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An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Primary Purpose

Uterine Atony, Postpartum Hemorrhage

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytocin
Oxytocin
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Atony focused on measuring Uterine atony, Postpartum hemorrhage, Vaginal delivery, Uterotonic, Oxytocin, Bolus, Evidence-based, Protocol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Vaginal Delivery

Exclusion Criteria:

  • Cesarean Delivery
  • Allergy to Oxytocin
  • Cardiac Arrhythmia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Conventional standard of care

    Evidence based protocol

    Arm Description

    Traditional administration of oxytocin at Lutheran Medical Center involves the use of two 20 IU / 1000 mL bags hung sequentially at a flow rate of 125 mL / hour each after the delivery of the anterior shoulder. This will total no more than 16 hours.

    The proposed evidence based protocol involves utilizing a single 30IU / 500mL bag of oxytocin. After the delivery of the anterior shoulder, an initial rapid infusion bolus of 50mL of the 30IU / 500mL at 999mL / hour. Three minutes after rapid infusion, uterine tone should be assessed. If inadequate uterine tone persists, a second rapid infusion at the same dose and rate as above should be given. If inadequate uterine tone persists, a third rapid infusion may be given. If adequate uterine tone is achieved after any rapid infusion, the remainder of the bag should be administered at a rate of 100mL / hour until finished. If adequate tone is not achieved, the remainder of the bag should be administered at 100mL / hour and additional uterotonic agents should be considered.

    Outcomes

    Primary Outcome Measures

    Estimated blood loss

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2015
    Last Updated
    July 27, 2017
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02410655
    Brief Title
    An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery
    Official Title
    An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Submission discarded. Study never enrolled subjects.
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    July 27, 2017 (Actual)
    Study Completion Date
    July 27, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Atony, Postpartum Hemorrhage
    Keywords
    Uterine atony, Postpartum hemorrhage, Vaginal delivery, Uterotonic, Oxytocin, Bolus, Evidence-based, Protocol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional standard of care
    Arm Type
    Active Comparator
    Arm Description
    Traditional administration of oxytocin at Lutheran Medical Center involves the use of two 20 IU / 1000 mL bags hung sequentially at a flow rate of 125 mL / hour each after the delivery of the anterior shoulder. This will total no more than 16 hours.
    Arm Title
    Evidence based protocol
    Arm Type
    Active Comparator
    Arm Description
    The proposed evidence based protocol involves utilizing a single 30IU / 500mL bag of oxytocin. After the delivery of the anterior shoulder, an initial rapid infusion bolus of 50mL of the 30IU / 500mL at 999mL / hour. Three minutes after rapid infusion, uterine tone should be assessed. If inadequate uterine tone persists, a second rapid infusion at the same dose and rate as above should be given. If inadequate uterine tone persists, a third rapid infusion may be given. If adequate uterine tone is achieved after any rapid infusion, the remainder of the bag should be administered at a rate of 100mL / hour until finished. If adequate tone is not achieved, the remainder of the bag should be administered at 100mL / hour and additional uterotonic agents should be considered.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    Pitocin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    Pitocin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Estimated blood loss
    Time Frame
    24 hours postpartum

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Vaginal Delivery Exclusion Criteria: Cesarean Delivery Allergy to Oxytocin Cardiac Arrhythmia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Violetta Lozovyy, MD
    Organizational Affiliation
    Lutheran Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jade King, BS
    Organizational Affiliation
    Lutheran Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Roulhac D Toledano, MD, PhD
    Organizational Affiliation
    Lutheran Medical Center
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kevin Fitzpatrick, MD
    Organizational Affiliation
    Lutheran Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

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