Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Blood loss in postpartum period defined by grams/hour
研究概览
简要总结
Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.
详细描述
The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time.
We hypothesize that:
- Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR.
- Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.
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
- Double (Participant, Investigator)
盲法说明
Covering of labels on IV fluids
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
- •Planned cesarean sections for singletons at or greater than 37 weeks gestational age
- •Primary or repeat cesarean section will be included
排除标准
- •Multiple fetal pregnancies
- •Hematologic disorders
- •Fetal anomalies
- •Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period.
- •Known contraindication to oxytocin
- •Hypersensitivity to oxytocin
- •Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.
研究组 & 干预措施
Control
Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
干预措施: Oxytocin (Drug)
Treatment
Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Blood loss in postpartum period defined by grams/hour
时间窗: 3-4 days after delivery
Measure pads used post-partum
次要结局
- Edinburgh post-partum depression scale >10(6 weeks)
- Need for additional uterotonics(24 hours after delivery)
- Change in Hemoglobin(24 hours)
- Quantity of narcotic pain medications(3-4 days after delivery)
- Attendance at post-partum visit(6 weeks)
- Post-partum complications(6 weeks)
- Change in Hematocrit(24 hours)
- Length of hospital stay(3-4 days after delivery)
- Continuation of breastfeeding(6 weeks)
- Need for blood transfusion(3-4 days after delivery)
研究者
Helana Pietragallo
Assistant Professor
Milton S. Hershey Medical Center