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Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT02229513
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : January 13, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

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. The investigators suspect that it may.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Uterine Atony Procedure: Uterine Cooling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Normal cesarean technique.
Experimental: Uterine Cooling
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 sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
Procedure: Uterine Cooling
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 sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
Other Name: Hush Slush Machine




Primary Outcome Measures :
  1. Blood Loss [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
    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. The amount of blood loss in the PACU will be measured by weighing pads.


Secondary Outcome Measures :
  1. Change in Pre- vs Post-operative Hematocrit [ Time Frame: 48 hours post operative period ]
  2. Use of Uterotonic Medications [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  3. Use of Extra Oxytocin [ Time Frame: Intraoperatively ]
  4. Use of Methergine [ Time Frame: Intraoperatively ]
  5. Use of Hemabate [ Time Frame: Intraoperatively ]
  6. Use of Cytotec [ Time Frame: Intraoperatively ]
  7. Bakri Bulb Placement [ Time Frame: Intraoperatively ]
  8. Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions [ Time Frame: Intraoperatively ]
  9. Requirement of Blood Products [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  10. Total Blood Loss Greater Than 1000 cc [ Time Frame: Intra-op, Post-Op ]
  11. Requirement of Cesarean Hysterectomy [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]

Other Outcome Measures:
  1. Patient Temperature [ Time Frame: Pre-op, Intra-op, Post-Op ]
  2. Total Time Uterus Wrapped [ Time Frame: During hysterotomy repair ]
  3. Uterine Temperature After Wrap Removed [ Time Frame: Immediately following hysterotomy repair ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant adult women of any gravidity, and gestational duration who present for cesarean section at Baylor University Medical Center in Dallas and who have given informed consent to be in the study.

Exclusion Criteria:

  • Women who refuse to be in the study, and women who are unable to consent due to emergent nature of the cesarean section will be excluded. 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.
  • Inability to exteriorize the uterus during c-section.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229513


Locations
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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Janice L Mitchell, MD Baylor University Medical Center Resident

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02229513     History of Changes
Other Study ID Numbers: 013-035
First Posted: September 1, 2014    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: January 19, 2018
Last Verified: December 2015
Keywords provided by Baylor Research Institute:
postpartum hemorrhage
uterine atony
cesarean section
cesarean hysterectomy
acute blood loss anemia
uterotonics
obstetric hemorrhage
severe hemorrhage
blood transfusion
obstetric emergencies
obstetrics
massive hemorrhage
hemorrhage
uterine cooling
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Uterine Inertia
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Dystocia