Ideal Time of Oxytocin Infusion During Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Total blood loss
研究概览
简要总结
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
详细描述
Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.
This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
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
- •Women undergoing cesarean section at Loyola Hospital
- •Women who read and speak the English and/or Spanish language
- •Women age 18 or older
排除标准
- •Women who deliver vaginally
- •Gestation under 37 weeks and 0 days
- •Women with coagulopathies
- •Multiple gestation pregnancies
- •Antepartum hemorrhage for example abruption
- •Placental abnormalities for example previa, accreta
研究组 & 干预措施
Control (Group A)
One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.
干预措施: Placebo (Drug)
Intervention (Group B)
One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Total blood loss
时间窗: At the completion of the surgery when patient is transferred to recovery from the operating room
Both the estimated blood loss and quantitative blood loss will be determined
次要结局
- Incidence of postpartum hemorrhage(At the completion of the surgery when patient is transferred to recovery from the operating room)
- Need for transfusion(In the immediate 24 hours post surgery)
- Change in pre-operative to post-operative hemoglobin levels(Baseline and Post operative day number 1)