A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries - Hemoglobin Screening in High Risk Population Versus by Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,679
- 试验地点
- 1
- 主要终点
- The rate of patients diagnosed with anemia
研究概览
简要总结
Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms versus screening of women at increased risk for post-partum anemia.
详细描述
Anemia is common following delivery. It is associated with some serious complications including increased risk for syncope and in severe cases even cardiogenic shock. Yet, anemia-associated symptoms might manifest relatively late after the patient have lost a fair amount of blood, which was not diagnosed early enough. To date, there are not acceptable guidelines for monitoring hemoglobin levels after delivery. Theoretically, there are 2 approaches for hemoglobin monitoring - one by taking hemoglobin levels in order to diagnose anemia in patients reporting anemia-associated symptoms. The other approach is by screening of women at increased risk for post-partum anemia. In the present study we aimed to compare those 2 approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women after vaginal delivery
排除标准
- •pregnant women with known sensitivity to the product iron sucrose
- •pregnant women after cesarean section
研究组 & 干预措施
Postpartum anemia diagnosis following symptoms
Post partum anemia will be assessed by taking hemoglobin level following symptoms consistent with anemia, severe postpartum hemorrhage or hemoglobin level below 8 g/dL in the first 5 days following delivery
干预措施: Monitoring hemoglobin levels following anemia associated symptoms (Other)
Postpartum anemia diagnosis following patients screening
Post partum anemia will be assessed by taking hemoglobin level in patients at increased risk to develop post-partum anemia in the first 5 days following delivery, defined as patients with initial (before or immediately after delivery) hemoglobin level of 10.5 g/dl or less regardless of symptoms, or in cases of severe post partum hemorrhage.
干预措施: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia (Other)
结局指标
主要结局
The rate of patients diagnosed with anemia
时间窗: Up to 3 days postpartum
Hemoglobin of 10 g/dl or below
The rate of patients who received treatment with intravenous iron sucrose
时间窗: Up to 3 days postpartum
次要结局
- The rate of patients who received blood transfusion(From delivery and up to 5 days)
- The rate of women with post-partum hemorrhage(From delivery and up to 5 days)
- The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward(From delivery and up to 5 days)
- The rate of women who needed uterotonic agents after their arrival to the maternity ward(From delivery and up to 5 days)
- The average blood tests number that was performed(From delivery and up to 5 days)
- Minimal and average hemoglobin level(From delivery and up to 5 days)
- The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire(6 weeks postpartum)
- Hemoglobin level 6 weeks postpartum(6 weeks postpartum)
研究者
enav yefet
MD/PhD
HaEmek Medical Center, Israel