Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Amount of Postpartum Hemorrhage
研究概览
简要总结
Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.
详细描述
Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.
The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.
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
- Single (Participant)
盲法说明
Patient will be blinded to the drug to be used
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:
- •History of postpartum hemorrhage.
- •Delivery of a macrosomic baby (> 4000 g).
- •Multiple gestation.
- •Polyhydramnios.
- •Grand Multiparity.
- •Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
- •Chorioamnionitis.
排除标准
- •• Patients without high risk for post-partum hemorrhage.
- •Patients at high risk for postpartum hemorrhage but will deliver vaginally.
- •Patients with medical disorders complicating pregnancy.
- •Patients with coagulation defects.
- •Preterm pregnancies.
研究组 & 干预措施
Oxytocin
the control group will be given 10 iu intravenously.
干预措施: Oxytocin (Drug)
Carbetocin
the treatment group will be given 100 microgram intravenously.
干预措施: Carbetocin (Drug)
结局指标
主要结局
Amount of Postpartum Hemorrhage
时间窗: First 24 hours after Delivery
Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood.
次要结局
未报告次要终点