Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Postoperative change in hemoglobin at 24 hours
研究概览
简要总结
This study will be conducted to compare the effects of pabal and oxytocin administered to prevent postpartum hemorrhage in patients who were followed in the delivery room due to vaginal labor but underwent cesarean section due to emergency situations.
详细描述
The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery.
The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs.
The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs.
According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included.
The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term pregnancy (>37 weeks gestation)
- •Singleton pregnancy
- •Vertex presentation
- •not having had a cesarean section before
- •emergency cesarean delivery (category 1)
- •low risk for postpartum hemorrhage
- •Vaginal labor has started (> 4 cm cervical dilatation) or a decision has been made (rupture of membranes, Abnormal findings on NST or other signs of fetal compromise.)
排除标准
- •Non-term pregnancy (< 37 weeks gestation)
- •Non- vertex presentation
- •antenatal high risk pregnancy for postpartum hemorrhage (preeclampsia/eclampsia, previous uterine surgery, placental anomalies)
- •Twin pregnancy
- •Elective cesarean section planned
研究组 & 干预措施
Oxytocin
Standard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean)
干预措施: Oxytocin (Drug)
carbetocin
Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
干预措施: Carbetocin (Drug)
结局指标
主要结局
Postoperative change in hemoglobin at 24 hours
时间窗: Baseline (preoperative) and within 24 hours after emergency cesarean delivery
Change in hemoglobin (g/dL) from preoperative baseline to the lowest hemoglobin value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups.
次要结局
- Need for additional uterotonic agents(Within 24 hours after cesarean delivery)
- Postoperative change in hematocrit at 24 hours(Baseline (preoperative) and within 24 hours after emergency cesarean delivery)
研究者
Tahir Eryılmaz
Gynecology and Obstetrics M.D. specialist
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi