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Oxytocin Dosing at Planned Cesarean Section and Anemia

Primary Purpose

Blood Loss Anemia, Uterine Atony With Hemorrhage

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Planned cesarean sections for singletons at or greater than 37 weeks gestational age
  • Primary or repeat cesarean section will be included

Exclusion Criteria:

  • Multiple fetal pregnancies
  • Hematologic disorders
  • Fetal anomalies
  • Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period.
  • Known contraindication to oxytocin
  • Hypersensitivity to oxytocin
  • Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control

    Treatment

    Arm Description

    Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.

    Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.

    Outcomes

    Primary Outcome Measures

    Blood loss in postpartum period defined by grams/hour
    Measure pads used post-partum

    Secondary Outcome Measures

    Change in Hemoglobin
    Pre-op hemoglobin and post-op hemoglobin
    Change in Hematocrit
    Pre-op hematocrit and post-op hematocrit
    Length of hospital stay
    Start of surgery to discharge (hours)
    Need for additional uterotonics
    Use of uterotonics
    Continuation of breastfeeding
    Is patient breastfeeding at 6 week post-partum visit
    Quantity of narcotic pain medications
    Number of narcotic tablets used from time of surgery to discharge
    Attendance at post-partum visit
    Did patient attend post-partum visit?
    Post-partum complications
    Did patient have surgical wound infection, endometritis?
    Need for blood transfusion
    Did the patient require blood transfusion?
    Edinburgh post-partum depression scale >10
    Did the patient score greater than 10 points on Edinburgh post-partum depression scale?

    Full Information

    First Posted
    August 1, 2017
    Last Updated
    February 19, 2019
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03361124
    Brief Title
    Oxytocin Dosing at Planned Cesarean Section and Anemia
    Official Title
    Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator no longer interested in proceeding with study
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    March 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    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.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.
    Detailed Description
    The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time. We hypothesize that: Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR. Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss Anemia, Uterine Atony With Hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized double-blinded controlled
    Masking
    ParticipantInvestigator
    Masking Description
    Covering of labels on IV fluids
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    Pitocin
    Intervention Description
    Administration of additional 20 mU Oxytocin
    Primary Outcome Measure Information:
    Title
    Blood loss in postpartum period defined by grams/hour
    Description
    Measure pads used post-partum
    Time Frame
    3-4 days after delivery
    Secondary Outcome Measure Information:
    Title
    Change in Hemoglobin
    Description
    Pre-op hemoglobin and post-op hemoglobin
    Time Frame
    24 hours
    Title
    Change in Hematocrit
    Description
    Pre-op hematocrit and post-op hematocrit
    Time Frame
    24 hours
    Title
    Length of hospital stay
    Description
    Start of surgery to discharge (hours)
    Time Frame
    3-4 days after delivery
    Title
    Need for additional uterotonics
    Description
    Use of uterotonics
    Time Frame
    24 hours after delivery
    Title
    Continuation of breastfeeding
    Description
    Is patient breastfeeding at 6 week post-partum visit
    Time Frame
    6 weeks
    Title
    Quantity of narcotic pain medications
    Description
    Number of narcotic tablets used from time of surgery to discharge
    Time Frame
    3-4 days after delivery
    Title
    Attendance at post-partum visit
    Description
    Did patient attend post-partum visit?
    Time Frame
    6 weeks
    Title
    Post-partum complications
    Description
    Did patient have surgical wound infection, endometritis?
    Time Frame
    6 weeks
    Title
    Need for blood transfusion
    Description
    Did the patient require blood transfusion?
    Time Frame
    3-4 days after delivery
    Title
    Edinburgh post-partum depression scale >10
    Description
    Did the patient score greater than 10 points on Edinburgh post-partum depression scale?
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Planned cesarean sections for singletons at or greater than 37 weeks gestational age Primary or repeat cesarean section will be included Exclusion Criteria: Multiple fetal pregnancies Hematologic disorders Fetal anomalies Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period. Known contraindication to oxytocin Hypersensitivity to oxytocin Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helana Pietragallo, MD
    Organizational Affiliation
    Penn State College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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