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Cooling the Uterus in C-section After Dysfunctional Labor

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ClinicalTrials.gov Identifier: NCT02910115
Recruitment Status : Unknown
Verified June 2017 by Baylor Research Institute.
Recruitment status was:  Enrolling by invitation
First Posted : September 21, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

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 for dysfunctional labor.

Condition or disease Intervention/treatment Phase
Blood Loss Dysfunctional Labor Uterine Atony Other: Cold laparotomy sponges Drug: Pitocin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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?
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Control Group
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.
Drug: Pitocin
Pitocin is administered intravenously according to the usual protocol.
Other Name: IV Oxytocin

Experimental: Study 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 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.

Other: Cold laparotomy sponges
Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline
Other Name: cold lap sponges

Drug: Pitocin
Pitocin is administered intravenously according to the usual protocol.
Other Name: IV Oxytocin




Primary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: up to 24 hours after surgery ]

Secondary Outcome Measures :
  1. Change in Hematocrit [ Time Frame: up to 24 hours after surgery ]
  2. Need for use of uterotonic medications [ Time Frame: during cesarean section ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910115


Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Jack Stecher, MD BUMC Labor and Delivery

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02910115     History of Changes
Other Study ID Numbers: 015-028
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Uterine Inertia
Dystocia
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs