Postpartum HemorrhageNCT02229513
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
A study testing Uterine Cooling in people with Postpartum Hemorrhage and Uterine Atony, run by Baylor Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony
- What is being tested?
- Uterine Cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Being tested
- Uterine Cooling
- Keywords
- 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
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine CoolingProcedure or surgery
Also called Hush Slush Machine
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal cesarean technique. |
| Uterine Cooling | Experimental | 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. Receives: Procedure: Uterine Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
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.
Measured: During surgery and in the PACU (approximately 3 total hours)
Secondary outcomes (11)
Change in Pre- vs Post-operative Hematocrit
Measured: 48 hours post operative period
Use of Uterotonic Medications
Measured: During surgery and in the PACU (approximately 3 total hours)
Use of Extra Oxytocin
Measured: Intraoperatively
Use of Methergine
Measured: Intraoperatively
Use of Hemabate
Measured: Intraoperatively
Use of Cytotec
Measured: Intraoperatively
Bakri Bulb Placement
Measured: Intraoperatively
Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions
Measured: Intraoperatively
Requirement of Blood Products
Measured: During surgery and in the PACU (approximately 3 total hours)
Total Blood Loss Greater Than 1000 cc
Measured: Intra-op, Post-Op
Requirement of Cesarean Hysterectomy
Measured: During surgery and in the PACU (approximately 3 total hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice L Mitchell, MD, Principal investigator, Baylor University Medical Center Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229513
- Sponsor's protocol ID
- 013-035
- Status last verified
- Dec 2015
- First submitted
- 7 Aug 2014
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02229513
- Acronym / sponsor ID
- 013-035
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Keywords
- postpartum hemorrhage, uterine atony, cesarean section, cesarean hysterectomy, acute blood loss anemia, uterotonics, obstetric hemorrhage, severe hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 13 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal cesarean technique. |
| Uterine Cooling | Experimental | Procedure: Uterine CoolingImmediately 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine CoolingAlso: Hush Slush MachineImmediately 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 or surgery | Uterine Cooling |
Primary outcome
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.
11 secondary outcomes
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice L Mitchell, MD principal investigator
Baylor University Medical Center Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Cooling in people with Postpartum Hemorrhage and Uterine Atony, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: During surgery and in the PACU (approximately 3 total hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.