Blood LossNCT02910115
Cooling the Uterus in C-section After Dysfunctional Labor
A study testing Cold laparotomy sponges and Pitocin in people with Blood Loss and Dysfunctional Labor, run by Baylor Research Institute.
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 section… 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
- Blood Loss, Dysfunctional Labor, Uterine Atony
- What is being tested?
- Cold laparotomy sponges and Pitocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2015to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 women of any age
- gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.
Who cannot join
- Women who refuse to be in the study
- women who are unable to consent due to emergent nature of the cesarean section
- 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.
About this study
Official title: Can Cooling the Uterus During Cesarean Delivery Reduce Blood Loss, Reduce Drug Use, and Decrease the Risk for Hysterectomy in Women With Dysfunctional Labor?
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 for dysfunctional labor.
Read the detailed description
Two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor. Dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours. Patients will be randomly assigned to the study group or the control group, and each group will have 100 patients.
Following the delivery of the fetus, patients in the control group will have IV Pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. Additional utero-tonic medications may be given to improve uterine contraction.
In the study group, following the delivery of the fetus, the uterus will be externalized in the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile, iced normal saline. Additional utero-tonic medications may also be given in the study group to improve uterine contraction.
Immediately after the delivery of the fetus and prior to the delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the suction canister. This amount of fluid in the suction canister will be noted and subtracted from the amount of fluid in the canister at the conclusion of the surgery.
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. Post surgical vaginal bleeding will be monitored and calculated until the patient is discharged from the labor and delivery unit. Use of utero-tonic medications will be recorded.
At the conclusion of the study, the amount of blood loss and utero-tonic drugs between the control and study groups will be compared. The need for additional surgeries, such as a hysterectomy or D\&C, will be compared between the two groups.
- Conditions
- Blood Loss, Dysfunctional Labor, Uterine Atony
- Being tested
- Cold laparotomy sponges, Pitocin
- Medical subject headings
- Hemorrhage, Dystocia, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold laparotomy spongesOther
Also called cold lap sponges
Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline
PitocinDrug
Also called IV Oxytocin
Pitocin is administered intravenously according to the usual protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Following delivery of the fetus patients in the control group will have Pitocin® administered to them intravenously according to the usual protocol. The uterus may be wrapped lap sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. At the discretion of the attending obstetrician additional uterotonic medications (Pitocin®, Methergine® Cytotec® and/or Hemabate®) may be given to improve uterine contraction. Receives: Drug: Pitocin |
| Study Group | Experimental | 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 cold laparotomy sponges saturated in sterile, iced normal saline. 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. Receives: Other: Cold laparotomy sponges; Drug: Pitocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Measured: up to 24 hours after surgery
Secondary outcomes (2)
Change in Hematocrit
Measured: up to 24 hours after surgery
Need for use of uterotonic medications
Measured: during cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start14 May 2015
- Primary completion10 Nov 2017
- Study completion10 Nov 2018
Why it stopped: Difficulty in acquiring patients in a reasonable amount of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- 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
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack Stecher, MD, Principal investigator, BUMC Labor and Delivery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910115
- Sponsor's protocol ID
- 015-028
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2016
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cooling the Uterus During Cesarean Delivery Reduce Blood Loss, Reduce Drug Use, and Decrease the Risk for Hysterectomy in Women With Dysfunctional Labor?
- ClinicalTrials.gov ID
- NCT02910115
- Acronym / sponsor ID
- 015-028
- Conditions
- Blood Loss, Dysfunctional Labor, Uterine Atony
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in acquiring patients in a reasonable amount of time.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 14 May 2015 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
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 for dysfunctional labor.
Detailed description
Two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor. Dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours. Patients will be randomly assigned to the study group or the control group, and each group will have 100 patients.
Following the delivery of the fetus, patients in the control group will have IV Pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. Additional utero-tonic medications may be given to improve uterine contraction.
In the study group, following the delivery of the fetus, the uterus will be externalized in the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile, iced normal saline. Additional utero-tonic medications may also be given in the study group to improve uterine contraction.
Immediately after the delivery of the fetus and prior to the delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the suction canister. This amount of fluid in the suction canister will be noted and subtracted from the amount of fluid in the canister at the conclusion of the surgery.
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. Post surgical vaginal bleeding will be monitored and calculated until the patient is discharged from the labor and delivery unit. Use of utero-tonic medications will be recorded.
At the conclusion of the study, the amount of blood loss and utero-tonic drugs between the control and study groups will be compared. The need for additional surgeries, such as a hysterectomy or D\&C, will be compared between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Drug: PitocinFollowing delivery of the fetus patients in the control group will have Pitocin® administered to them intravenously according to the usual protocol. The uterus may be wrapped lap sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. At the discretion of the attending obstetrician additional uterotonic medications (Pitocin®, Methergine® Cytotec® and/or Hemabate®) may be given to improve uterine contraction. |
| Study Group | Experimental | Other: Cold laparotomy sponges, Drug: PitocinFollowing 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 cold laparotomy sponges saturated in sterile, iced normal saline. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pregnant women of any age
- gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.
Key exclusion criteria (3 listed)
- Women who refuse to be in the study
- women who are unable to consent due to emergent nature of the cesarean section
- 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.
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 |
|---|---|---|
| Cold laparotomy spongesAlso: cold lap spongesCold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline | Other | Study Group |
| PitocinAlso: IV OxytocinPitocin is administered intravenously according to the usual protocol. | Drug | Control Group, Study Group |
Primary outcome
Estimated Blood Loss
Time frame: up to 24 hours after surgery
2 secondary outcomes
Change in Hematocrit
Time frame: up to 24 hours after surgery
Need for use of uterotonic medications
Time frame: during cesarean section
Results and safety
The study was stopped early (reason given: Difficulty in acquiring patients in a reasonable amount of time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Jack Stecher, MD principal investigator
BUMC Labor and Delivery
Questions about this trial
What is this clinical trial studying?
A study testing Cold laparotomy sponges and Pitocin in people with Blood Loss and Dysfunctional Labor, run by Baylor Research Institute.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Difficulty in acquiring patients in a reasonable amount of time.). Results are not available in the source record.
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?
Estimated Blood Loss (time frame: up to 24 hours after surgery). 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 26 Jan 2026.