Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE September 1, 2014
Results First Submitted Date  ICMJE October 28, 2015
Results First Posted Date  ICMJE January 13, 2016
Last Update Posted Date January 19, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02229513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • Change in Pre- vs Post-operative Hematocrit [ Time Frame: 48 hours post operative period ]
  • Use of Uterotonic Medications [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  • Use of Extra Oxytocin [ Time Frame: Intraoperatively ]
  • Use of Methergine [ Time Frame: Intraoperatively ]
  • Use of Hemabate [ Time Frame: Intraoperatively ]
  • Use of Cytotec [ Time Frame: Intraoperatively ]
  • Bakri Bulb Placement [ Time Frame: Intraoperatively ]
  • Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions [ Time Frame: Intraoperatively ]
  • Requirement of Blood Products [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  • Total Blood Loss Greater Than 1000 cc [ Time Frame: Intra-op, Post-Op ]
  • Requirement of Cesarean Hysterectomy [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
  • Use of Uterotonic Medications [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  • Requirement of Blood Products [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
  • Requirement of Cesarean Hysterectomy [ Time Frame: During surgery and in the PACU (approximately 3 total hours) ]
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2015)
  • Patient Temperature [ Time Frame: Pre-op, Intra-op, Post-Op ]
  • Total Time Uterus Wrapped [ Time Frame: During hysterotomy repair ]
  • Uterine Temperature After Wrap Removed [ Time Frame: Immediately following hysterotomy repair ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
Official Title  ICMJE Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
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.
Detailed Description

Study Design:

Patients will be randomly assigned to either the study group or the control group. Patients may receive regional (epidural or spinal/epidural) or general anesthesia.Initially, the investigators plan to enroll 200 subjects, 100 to the study group and 100 to the control group.

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 sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. 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.

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. The surface temperature of the uterus will be measured using an infrared thermometer prior to replacing the uterus into the abdomen.

Two surgical suction canisters will be available. Immediately after delivery of the fetus and prior to delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the first canister. The second suction canister will be used to aspirate blood and fluid until the conclusion of the operation.

At the conclusion of the surgery blood loss will be calculated by measuring the content of blood in the second canister minus the amount of irrigation fluid used, and by weighing the surgical sponges. Average blood loss during cesarean sections has previously been reported as 500 to 1000 cc.

The duration of cooling the uterus will be recorded.

Use and amount of uterotonic medications also will be recorded.

During the surgery the patient's vital signs will be monitored in the usual fashion. Particular attention will be paid to a change in her temperature. Warmed blankets and forced air warming blankets will be used to maintain normothermia, if required.

At the conclusion of the study the amount of blood loss between the control and study groups, and the amount of uterotonic drugs will be calculated and compared. The number of patients in each group who require additional surgeries, e.g. hysterectomy or D&C, will be monitored. Pre-op and post-op hemograms will be compared if obtained at the discretion of the attending obstetrician. Blood product administration will be recorded.

Determination of an ideal temperature of cooling towels is not an objective of the study. We're asking a qualitative question, not a quantitative question at this time.

Study Rationale: The uterus is a smooth muscle whose contraction is modulated most directly by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus and beneath the placenta enlarge to provide adequate perfusion to the placenta. After separation of the placenta the uterine smooth muscle cells contract in a pincer-like action to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately 4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000 cesarean sections require hysterectomy to control bleeding.

Release of calcium ions from sarcoplasmic reticulum stores is the immediate initiator of contraction, and calcium's diffusion from the muscle filaments and re-uptake by the sarcoplasmic reticulum results in relaxation of contraction. In some smooth muscles cold enhances contraction; perhaps by slowing the re-uptake of calcium. When the usual pharmacologic agents fail to induce adequate contraction of the uterine smooth muscle, the investigators suspect that application of cold may.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Postpartum Hemorrhage
  • Uterine Atony
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Uterine Cooling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229513
Other Study ID Numbers  ICMJE 013-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janice L Mitchell, MD Baylor University Medical Center Resident
PRS Account Baylor Research Institute
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP