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Cooling the Uterus in C-section After Dysfunctional Labor

2016-09-21 20:23:21 | BioPortfolio

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.

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Blood Loss

Intervention

Cold laparotomy sponges, Pitocin

Status

Enrolling by invitation

Source

Baylor Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-21T20:23:21-0400

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Medical and Biotech [MESH] Definitions

The chilling of a tissue or organ during decreased BLOOD perfusion or in the absence of blood supply. Cold ischemia time during ORGAN TRANSPLANTATION begins when the organ is cooled with a cold perfusion solution after ORGAN PROCUREMENT surgery, and ends after the tissue reaches physiological temperature during implantation procedures. WARM ISCHEMIA TIME starts then and ends with completion of SURGICAL ANASTOMOSIS.

Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum).

A condition characterized by the presence of abnormal quantities of CRYOGLOBULINS in the blood. Upon cold exposure, these abnormal proteins precipitate into the microvasculature leading to restricted blood flow in the exposed areas.

Loss of blood during a surgical procedure.

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