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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Postpartum Hemorrhage
Uterine Atony
Intervention Procedure: Uterine Cooling
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description Normal cesarean technique. 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.
Period Title: Overall Study
Started 100 100
Completed 100 100
Not Completed 0 0
Arm/Group Title Control Uterine Cooling Total
Hide Arm/Group Description Normal cesarean technique. Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus 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. Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
30.1  (4.8) 31.7  (5.1) 30.9  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   4.0%
5
   5.0%
9
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  14.0%
17
  17.0%
31
  15.5%
White
82
  82.0%
78
  78.0%
160
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Height (ft)  
Mean (Standard Deviation)
Unit of measure:  Feet
Number Analyzed 100 participants 100 participants 200 participants
5.4  (0.2) 5.4  (0.3) 5.4  (0.3)
Weight (lbs)  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 100 participants 100 participants 200 participants
200  (49) 187  (39) 194  (45)
Gravidity  
Mean (Full Range)
Unit of measure:  Pregnancies
Number Analyzed 100 participants 100 participants 200 participants
2.5
(1 to 7)
2.4
(1 to 9)
2.5
(1 to 9)
Parity  
Mean (Full Range)
Unit of measure:  Births
Number Analyzed 100 participants 100 participants 200 participants
1.0
(0 to 5)
1.0
(0 to 4)
1.0
(0 to 5)
Gestational Age (wks)  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 100 participants 100 participants 200 participants
38.5  (2.2) 38.0  (4.2) 38.3  (3.4)
Fetal Presentation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Cephalic 84 83 167
Breech 14 14 28
Transverse 1 2 3
Oblique 1 0 1
Compound 0 1 1
Multiple Gestations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
yes 11 7 18
no 89 93 182
Fetal Weight (g)  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 100 participants 100 participants 200 participants
3504  (852) 3471  (822) 3488  (835)
Previous Cesareans  
Mean (Full Range)
Unit of measure:  Cesareans
Number Analyzed 100 participants 100 participants 200 participants
0.8
(0 to 3)
0.7
(0 to 3)
0.8
(0 to 3)
Trial of Labor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
yes 7 16 23
no 93 84 177
Pre-op Epidural  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
yes 9 17 26
no 91 83 174
1.Primary Outcome
Title Blood Loss
Hide Description 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.
Time Frame During surgery and in the PACU (approximately 3 total hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: cc
Intraoperative blood loss 616  (411) 418  (317)
PACU blood loss 141  (199) 106  (170)
Total blood loss 756  (462) 536  (429)
2.Secondary Outcome
Title Change in Pre- vs Post-operative Hematocrit
Hide Description [Not Specified]
Time Frame 48 hours post operative period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: percent
4.3  (3.6) 4.8  (3.1)
3.Secondary Outcome
Title Use of Uterotonic Medications
Hide Description [Not Specified]
Time Frame During surgery and in the PACU (approximately 3 total hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 5 4
no 95 96
4.Secondary Outcome
Title Use of Extra Oxytocin
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 1 1
no 99 99
5.Secondary Outcome
Title Use of Methergine
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 2 2
no 98 98
6.Secondary Outcome
Title Use of Hemabate
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 1 2
no 99 98
7.Secondary Outcome
Title Use of Cytotec
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 4 3
no 96 97
8.Secondary Outcome
Title Bakri Bulb Placement
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 3 0
no 97 100
9.Secondary Outcome
Title Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions
Hide Description [Not Specified]
Time Frame Intraoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 6 5
no 94 95
10.Secondary Outcome
Title Requirement of Blood Products
Hide Description [Not Specified]
Time Frame During surgery and in the PACU (approximately 3 total hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 2 3
no 98 97
11.Secondary Outcome
Title Total Blood Loss Greater Than 1000 cc
Hide Description [Not Specified]
Time Frame Intra-op, Post-Op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 21 9
no 79 91
12.Secondary Outcome
Title Requirement of Cesarean Hysterectomy
Hide Description [Not Specified]
Time Frame During surgery and in the PACU (approximately 3 total hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
yes 0 0
no 100 100
13.Other Pre-specified Outcome
Title Patient Temperature
Hide Description [Not Specified]
Time Frame Pre-op, Intra-op, Post-Op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: degrees Fahrenheit
Pre-operative 98.3  (0.4) 98.4  (0.7)
Intra-operative 97.7  (1.0) 97.9  (0.7)
Post-operative 97.8  (0.4) 97.9  (1.0)
14.Other Pre-specified Outcome
Title Total Time Uterus Wrapped
Hide Description [Not Specified]
Time Frame During hysterotomy repair
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: minutes
9.3  (4.3) 9.4  (4.0)
15.Other Pre-specified Outcome
Title Uterine Temperature After Wrap Removed
Hide Description [Not Specified]
Time Frame Immediately following hysterotomy repair
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description:
Normal cesarean technique.
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.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: degrees Fahrenheit
88.3  (3.0) 75.5  (7.8)
Time Frame Approximately 4 days
Adverse Event Reporting Description All patients received routine post-operative and postpartum care. Their vitals were monitored for evidence of hypothermia or infection, and they received both routine post-operative day 1 labs, including a CBC, as well as follow labs as indicated. They were monitored for evidence of delayed postpartum hemorrhage.
 
Arm/Group Title Control Uterine Cooling
Hide Arm/Group Description Normal cesarean technique. 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.
All-Cause Mortality
Control Uterine Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Uterine Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Uterine Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Janice Mitchell, PI
Organization: Baylor University Medical Center
Phone: 713-705-6240
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02229513     History of Changes
Other Study ID Numbers: 013-035
First Submitted: August 7, 2014
First Posted: September 1, 2014
Results First Submitted: October 28, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 19, 2018