Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Uterine Tone
研究概览
简要总结
Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.
It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).
The primary objectives of the study include:
- Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
- Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
- Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.
The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy Parturients
- •Elective cesarean Delivery
- •Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
- •Singleton fetus
- •Vertex presentation
- •Age > 18
- •BMI < 40
- •Height > 5'2" and < 5"8"
- •Written informed consent
排除标准
- •Placenta previa
- •Multiple gestation
- •Preeclampsia
- •Gestational Diabetes or pre-existing diabetes
- •Macrosomia (estimated fetal weight prior to delivery)
- •Polyhydramnios
- •Oligohydramnios
- •Uterine fibroids
- •More than 2 previous cesarean deliveries
- •Suspected adherent placenta (acreta/increta/percreta)
- •Planned general anesthesia
研究组 & 干预措施
Intramyometrial oxytocin
干预措施: Oxytocin (Drug)
Intramyometrial Saline
干预措施: Saline (Drug)
结局指标
主要结局
Uterine Tone
时间窗: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
次要结局
- Estimated Blood Loss(Immediately Post-operatively)
- Pre-operative to post-operative change in hematocrit(24 hrs post-operative)
- Need for additional unterotonics(Immediately post delivery)
- Need for blood pressure support(Intra-operative period following administration of oxytocin)