Efficacy and safety of carbetocin versus oxytocin in prevention of post partum hemorrhage in high risk women.
An Open label randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The total amount of blood loss within 24 hours postpartum measured by V drapes
研究概览
简要总结
Ethical clearance and informed consent will be done.
Information on age, education, parity, occupation and obstetric history was obtained from the mother using a questionnaire
Using a computer generated randomisation sequence, women eligible in the study will be randomly divided into two equal groups with at least one risk factor and a prospective open blinded randomised study will be conducted on 120 (60 in each group) pregnant women divided equally between two groups
- Group 1- Oxytocin group
- Group 2 - Carbetocin group
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
- •Women of age between 18-35 years of Gestational age of 37-42 weeks Patients who have given written informed consent Women at risk of PPH including Factors resulting in overdistention of the uterus Multiple gestation (eg, twins) Fetal macrosomia Polyhydramnios Nature of labor and delivery Induced labor Precipitous labor (lasting less than 3 hours) Prolonged labor Forceps or vacuum-assisted delivery Cesarean delivery Factors relating to the placenta Abruptio placentae Placenta previa Abnormal implantation High multiparity 
 Preeclampsia Chorioamnionitis  Amniotic fluid embolism May precipitate disseminated intravascular coagulation, resulting in consumptive coagulopathy and uncontrolled blood loss Under general Anesthesia Medications Prolonged oxytocin use Magnesium sulfate Anticoagulants.
排除标准
- •Gestational age less than 37 or more than 42 weeks History of thromboembolic disorders, Cases suffering from chronic medical diseases (cardiac, hepatic, renal), Not giving consent.
结局指标
主要结局
The total amount of blood loss within 24 hours postpartum measured by V drapes
时间窗: The total amount of blood loss within 24 hours postpartum measured by V drapes
Adverse maternal events like nausea vomiting tachycardia flushing dizziness headache shivering metallic taste dyspnea palpitations itching
时间窗: The total amount of blood loss within 24 hours postpartum measured by V drapes
Hemodynamic status will be measured at 0 min 30 min 60min 120 min
时间窗: The total amount of blood loss within 24 hours postpartum measured by V drapes
次要结局
- Need for second line uterotonics and interventions(Need of blood and blood products)
研究者
SMRITI BAG
KING GEORGE MEDICAL COLLEGE AND UNIVERSITY