Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blood Loss
研究概览
简要总结
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. The investigators suspect that it may.
详细描述
Study Design:
Patients will be randomly assigned to either the study group or the control group. Patients may receive regional (epidural or spinal/epidural) or general anesthesia.Initially, the investigators plan to enroll 200 subjects, 100 to the study group and 100 to the control 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 sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. 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.
Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen. The surface temperature of the uterus will be measured using an infrared thermometer prior to replacing the uterus into the abdomen.
Two surgical suction canisters will be available. Immediately after delivery of the fetus and prior to delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the first canister. The second suction canister will be used to aspirate blood and fluid until the conclusion of the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant adult women of any gravidity, and gestational duration who present for cesarean section at Baylor University Medical Center in Dallas and who have given informed consent to be in the study.
排除标准
- •Women who refuse to be in the study, and women who are unable to consent due to emergent nature of the cesarean section will be excluded. 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.
- •Inability to exteriorize the uterus during c-section.
研究组 & 干预措施
Control
Normal cesarean technique.
Uterine Cooling
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 sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
干预措施: Uterine Cooling (Procedure)
结局指标
主要结局
Blood Loss
时间窗: During surgery and in the PACU (approximately 3 total hours)
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. The amount of blood loss in the PACU will be measured by weighing pads.
次要结局
- Bakri Bulb Placement(Intraoperatively)
- Total Blood Loss Greater Than 1000 cc(Intra-op, Post-Op)
- Use of Cytotec(Intraoperatively)
- Use of Extra Oxytocin(Intraoperatively)
- Requirement of Blood Products(During surgery and in the PACU (approximately 3 total hours))
- Change in Pre- vs Post-operative Hematocrit(48 hours post operative period)
- Use of Methergine(Intraoperatively)
- Use of Hemabate(Intraoperatively)
- Use of Uterotonic Medications(During surgery and in the PACU (approximately 3 total hours))
- Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions(Intraoperatively)
- Requirement of Cesarean Hysterectomy(During surgery and in the PACU (approximately 3 total hours))