Trial Outcomes & Findings for Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage (NCT NCT02229513)
NCT ID: NCT02229513
Last Updated: 2018-01-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
During surgery and in the PACU (approximately 3 total hours)
Results posted on
2018-01-19
Participant Flow
Participant milestones
| Measure |
Control
Normal cesarean technique.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
Baseline characteristics by cohort
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height (ft)
|
5.4 feet
STANDARD_DEVIATION 0.2 • n=5 Participants
|
5.4 feet
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.4 feet
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Weight (lbs)
|
200 pounds
STANDARD_DEVIATION 49 • n=5 Participants
|
187 pounds
STANDARD_DEVIATION 39 • n=7 Participants
|
194 pounds
STANDARD_DEVIATION 45 • n=5 Participants
|
|
Gravidity
|
2.5 pregnancies
n=5 Participants
|
2.4 pregnancies
n=7 Participants
|
2.5 pregnancies
n=5 Participants
|
|
Parity
|
1.0 births
n=5 Participants
|
1.0 births
n=7 Participants
|
1.0 births
n=5 Participants
|
|
Gestational Age (wks)
|
38.5 weeks
STANDARD_DEVIATION 2.2 • n=5 Participants
|
38.0 weeks
STANDARD_DEVIATION 4.2 • n=7 Participants
|
38.3 weeks
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Fetal Presentation
Cephalic
|
84 participants
n=5 Participants
|
83 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Fetal Presentation
Breech
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Fetal Presentation
Transverse
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Fetal Presentation
Oblique
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Fetal Presentation
Compound
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Multiple Gestations
yes
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Multiple Gestations
no
|
89 participants
n=5 Participants
|
93 participants
n=7 Participants
|
182 participants
n=5 Participants
|
|
Fetal Weight (g)
|
3504 grams
STANDARD_DEVIATION 852 • n=5 Participants
|
3471 grams
STANDARD_DEVIATION 822 • n=7 Participants
|
3488 grams
STANDARD_DEVIATION 835 • n=5 Participants
|
|
Previous Cesareans
|
0.8 cesareans
n=5 Participants
|
0.7 cesareans
n=7 Participants
|
0.8 cesareans
n=5 Participants
|
|
Trial of Labor
yes
|
7 participants
n=5 Participants
|
16 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Trial of Labor
no
|
93 participants
n=5 Participants
|
84 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Pre-op Epidural
yes
|
9 participants
n=5 Participants
|
17 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Pre-op Epidural
no
|
91 participants
n=5 Participants
|
83 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Blood Loss
Intraoperative blood loss
|
616 cc
Standard Deviation 411
|
418 cc
Standard Deviation 317
|
|
Blood Loss
PACU blood loss
|
141 cc
Standard Deviation 199
|
106 cc
Standard Deviation 170
|
|
Blood Loss
Total blood loss
|
756 cc
Standard Deviation 462
|
536 cc
Standard Deviation 429
|
SECONDARY outcome
Timeframe: 48 hours post operative periodOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Change in Pre- vs Post-operative Hematocrit
|
4.3 percent
Standard Deviation 3.6
|
4.8 percent
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: During surgery and in the PACU (approximately 3 total hours)Outcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Uterotonic Medications
yes
|
5 participants
|
4 participants
|
|
Use of Uterotonic Medications
no
|
95 participants
|
96 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Extra Oxytocin
yes
|
1 participants
|
1 participants
|
|
Use of Extra Oxytocin
no
|
99 participants
|
99 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Methergine
yes
|
2 participants
|
2 participants
|
|
Use of Methergine
no
|
98 participants
|
98 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Hemabate
no
|
99 participants
|
98 participants
|
|
Use of Hemabate
yes
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Cytotec
yes
|
4 participants
|
3 participants
|
|
Use of Cytotec
no
|
96 participants
|
97 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Bakri Bulb Placement
yes
|
3 participants
|
0 participants
|
|
Bakri Bulb Placement
no
|
97 participants
|
100 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions
yes
|
6 participants
|
5 participants
|
|
Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions
no
|
94 participants
|
95 participants
|
SECONDARY outcome
Timeframe: During surgery and in the PACU (approximately 3 total hours)Outcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Requirement of Blood Products
yes
|
2 participants
|
3 participants
|
|
Requirement of Blood Products
no
|
98 participants
|
97 participants
|
SECONDARY outcome
Timeframe: Intra-op, Post-OpOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Total Blood Loss Greater Than 1000 cc
yes
|
21 participants
|
9 participants
|
|
Total Blood Loss Greater Than 1000 cc
no
|
79 participants
|
91 participants
|
SECONDARY outcome
Timeframe: During surgery and in the PACU (approximately 3 total hours)Outcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Requirement of Cesarean Hysterectomy
yes
|
0 participants
|
0 participants
|
|
Requirement of Cesarean Hysterectomy
no
|
100 participants
|
100 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-op, Intra-op, Post-OpOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Patient Temperature
Pre-operative
|
98.3 degrees Fahrenheit
Standard Deviation 0.4
|
98.4 degrees Fahrenheit
Standard Deviation 0.7
|
|
Patient Temperature
Intra-operative
|
97.7 degrees Fahrenheit
Standard Deviation 1.0
|
97.9 degrees Fahrenheit
Standard Deviation 0.7
|
|
Patient Temperature
Post-operative
|
97.8 degrees Fahrenheit
Standard Deviation 0.4
|
97.9 degrees Fahrenheit
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hysterotomy repairOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Total Time Uterus Wrapped
|
9.3 minutes
Standard Deviation 4.3
|
9.4 minutes
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately following hysterotomy repairOutcome measures
| Measure |
Control
n=100 Participants
Normal cesarean technique.
|
Uterine Cooling
n=100 Participants
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.
|
|---|---|---|
|
Uterine Temperature After Wrap Removed
|
88.3 degrees Fahrenheit
Standard Deviation 3.0
|
75.5 degrees Fahrenheit
Standard Deviation 7.8
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Uterine Cooling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Janice Mitchell, PI
Baylor University Medical Center
Phone: 713-705-6240
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place