Cooling the Uterus in C-section After Dysfunctional Labor

NCT ID: NCT02910115

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-14
• Study Completion Date: 2018-11-10

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Study Groups

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.

Group Type: OTHER

Pitocin

Intervention Type: DRUG

Pitocin is administered intravenously according to the usual protocol.

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.

Group Type: EXPERIMENTAL

Cold laparotomy sponges

Intervention Type: OTHER

Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline

Pitocin

Intervention Type: DRUG

Pitocin is administered intravenously according to the usual protocol.

Interventions

Cold laparotomy sponges

Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline

Intervention Type: OTHER

Pitocin

Pitocin is administered intravenously according to the usual protocol.

Intervention Type: DRUG

Other Intervention Names

cold lap sponges; IV Oxytocin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack Stecher, MD

Role: PRINCIPAL_INVESTIGATOR

BUMC Labor and Delivery

Other Identifiers

015-028

Identifier Type: -

Identifier Source: org_study_id