Carbetocin versus oxytocin in the prevention of atonic postpartum hemorrhage following normal vaginal delivery - An interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Uterine tone and vaginal bleeding immediately and at 1, 2, 3 hours post delivery in both the
研究概览
简要总结
The most important step in the active management of third stage of labour is the use of uterotonic agent.conventionally we have been using oxytocin as the uterotonic agent.however it has to be kept under refrigeration during transport and storage for maintaining its potency.carbetocin is an oxytocin analogue which doesnot require refrigeration.In our study we aim to compare the efficacy of both these agents in the prevention of atonic postpartum hemorrhage following normal vaginal delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women in age group 18-35 years
- •Singleton pregnancy
- •Term (37-42 weeks of gestation)
- •Women who undergo vaginal delivery
- •Patients willing to give informed consent.
排除标准
- •High risk pregnant women including: antepartum hemorrhage- placenta previa, abruptio placentae, preeclampsia, eclampsia, GDM A2, multiple pregnancies, post cesarean pregnancy, polyhydramnios, macrosomia, patients with gynecological disorders such as myomas â— Medical disorders: coagulation disorders, thrombocytopenia (platelets <1.5 lakh), renal disorders, hepatic disorders, heart disease, asthma, epilepsy, women with HIV â— Intellectual challenged women â— Known allergy to carbetocin â— Patients not willing to sign informed consent.
结局指标
主要结局
Uterine tone and vaginal bleeding immediately and at 1, 2, 3 hours post delivery in both the
时间窗: 1-3 Days after Randomization
groups
时间窗: 1-3 Days after Randomization
1.Estimated blood loss (ml) and PPH (blood loss 500 ml) in both study groups
时间窗: 1-3 Days after Randomization
2. Need for use of additional uterotonic drugs and/or blood transfusion in both the groups
时间窗: 1-3 Days after Randomization
次要结局
- Change in value of hemoglobin, Hematocrit and Packed cell volume (PCV)Pre and 24 -hour(post-delivery in both the groups)
研究者
Kondamudi Saranya
AIIMS Mangalagiri