Cooling the Uterus in C-section After Dysfunctional Labor

Not Applicable

• Conditions: Blood Loss; Uterine Atony; Dysfunctional Labor
• Interventions: Other: Cold laparotomy sponges; Drug: Pitocin

• Registration Number: NCT02910115
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-14
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12
• Primary Completion: 2017-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Cold laparotomy sponges	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.
Control Group	Pitocin	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.
Study Group	Pitocin	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.

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	up to 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Need for use of uterotonic medications	during cesarean section
Change in Hematocrit	up to 24 hours after surgery