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Cooling the Uterus in C-section After Dysfunctional Labor

Primary Purpose

Blood Loss, Dysfunctional Labor, Uterine Atony

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold laparotomy sponges
Pitocin
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss

Eligibility Criteria

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

Inclusion criteria:

  • pregnant women of any age
  • gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.

Exclusion criteria:

  • Women who refuse to be in the study
  • women who are unable to consent due to emergent nature of the cesarean section
  • women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control Group

    Study Group

    Arm Description

    Following delivery of the fetus patients in the control group will have Pitocin® administered to them intravenously according to the usual protocol. The uterus may be wrapped lap sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. At the discretion of the attending obstetrician additional uterotonic medications (Pitocin®, Methergine® Cytotec® and/or Hemabate®) may be given to improve uterine contraction.

    Following delivery of the fetus, patients in the study group also will have Pitocin® administered to them according to the usual protocol. Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in cold laparotomy sponges saturated in sterile, iced normal saline. The skin of the abdomen will be draped to prevent contact with the cold towels. Additional uterotonic medications may be given at the discretion of the attending obstetrician.

    Outcomes

    Primary Outcome Measures

    Estimated Blood Loss

    Secondary Outcome Measures

    Change in Hematocrit
    Need for use of uterotonic medications

    Full Information

    First Posted
    January 14, 2016
    Last Updated
    June 9, 2017
    Sponsor
    Baylor Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02910115
    Brief Title
    Cooling the Uterus in C-section After Dysfunctional Labor
    Official Title
    Can Cooling the Uterus During Cesarean Delivery Reduce Blood Loss, Reduce Drug Use, and Decrease the Risk for Hysterectomy in Women With Dysfunctional Labor?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    September 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baylor Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section for dysfunctional labor.
    Detailed Description
    Two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor. Dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours. Patients will be randomly assigned to the study group or the control group, and each group will have 100 patients. Following the delivery of the fetus, patients in the control group will have IV Pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. Additional utero-tonic medications may be given to improve uterine contraction. In the study group, following the delivery of the fetus, the uterus will be externalized in the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile, iced normal saline. Additional utero-tonic medications may also be given in the study group to improve uterine contraction. Immediately after the delivery of the fetus and prior to the delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the suction canister. This amount of fluid in the suction canister will be noted and subtracted from the amount of fluid in the canister at the conclusion of the surgery. At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. Post surgical vaginal bleeding will be monitored and calculated until the patient is discharged from the labor and delivery unit. Use of utero-tonic medications will be recorded. At the conclusion of the study, the amount of blood loss and utero-tonic drugs between the control and study groups will be compared. The need for additional surgeries, such as a hysterectomy or D&C, will be compared between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss, Dysfunctional Labor, Uterine Atony

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    Following delivery of the fetus patients in the control group will have Pitocin® administered to them intravenously according to the usual protocol. The uterus may be wrapped lap sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. At the discretion of the attending obstetrician additional uterotonic medications (Pitocin®, Methergine® Cytotec® and/or Hemabate®) may be given to improve uterine contraction.
    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    Following delivery of the fetus, patients in the study group also will have Pitocin® administered to them according to the usual protocol. Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in cold laparotomy sponges saturated in sterile, iced normal saline. The skin of the abdomen will be draped to prevent contact with the cold towels. Additional uterotonic medications may be given at the discretion of the attending obstetrician.
    Intervention Type
    Other
    Intervention Name(s)
    Cold laparotomy sponges
    Other Intervention Name(s)
    cold lap sponges
    Intervention Description
    Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    Pitocin
    Other Intervention Name(s)
    IV Oxytocin
    Intervention Description
    Pitocin is administered intravenously according to the usual protocol.
    Primary Outcome Measure Information:
    Title
    Estimated Blood Loss
    Time Frame
    up to 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Change in Hematocrit
    Time Frame
    up to 24 hours after surgery
    Title
    Need for use of uterotonic medications
    Time Frame
    during cesarean section

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: pregnant women of any age gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study. Exclusion criteria: Women who refuse to be in the study women who are unable to consent due to emergent nature of the cesarean section women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jack Stecher, MD
    Organizational Affiliation
    BUMC Labor and Delivery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cooling the Uterus in C-section After Dysfunctional Labor

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