Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood loss (measured in cc)
研究概览
简要总结
Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 20-40 years.
- •Gestational age between 36-39 weeks.
- •Patients who will undergo an elective cesarean section.
- •Full-term alive baby.
- •Non-scarred uterus.
- •No obstetric or medical complications.
- •No bleeding tendency.
排除标准
- •Patients at less than 36 gestational weeks.
- •Patient refusal.
- •Patients who have thrombo-embolic complications.
- •Patients with obstetric and medical complications.
- •Patients with anomalous fetuses.
- •Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs.
- •Patients with obstetric cholestasis.
- •Patients with a previous history of preterm labor.
- •Patients with multiple pregnancies.
- •Gestational hypertension or preeclampsia.
- •Blood clotting disorders.
- •Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta.
- •Placental abruption and Placenta previa.
结局指标
主要结局
Blood loss (measured in cc)
时间窗: During Cesarean Section
Prothrombin time of the mother (measured in seconds)
时间窗: 6 hour postmartum
Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)
时间窗: 6 hour postmartum
Prothrombin Concentration (PC) of the mother (measured in %)
时间窗: 6 hour postmartum
Prothrombin time of the newborn (measured in seconds)
时间窗: immediately after birth
Prothrombin Concentration (PC) of the newborn (measured in %)
时间窗: immediately after birth
次要结局
未报告次要终点
研究者
Mazen Abdel Rasheed
Researcher
National Research Centre, Egypt