Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Hemoglobin drop of 2g% or more within 24 - 36 hours
研究概览
简要总结
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are particularly important during the critical period of mother-child bonding. Hemoglobin levels in the first 24 hours after delivery do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after delivery due to the initial redistribution of plasma volume. The aim of this study was to examine whether postpartum ultrasound examination precedes laboratory test results in the diagnosis of anemia due to blood loss after cesarean section.
详细描述
According to the World Health Organization, postpartum anemia should be recognized as a major health concern, as it affects the quality of life, cognitive and emotional function of the mother, which are particularly important during the critical period of mother-child bonding. Additionally, anemia may impact mother-infant interaction, potentially leading to cognitive delays in infants. Furthermore, postpartum anemia increases the risk of postpartum depression, the need for blood transfusions, length of hospital stays, and hospitalization costs.
Hemoglobin (HB) levels within the first 24 hours postpartum do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after birth due to initial plasma volume redistribution. Diagnosis is made by measuring HB levels, and anemia is defined when HB is below 10 g at 48 hours postpartum. Postpartum anemia requires immediate treatment upon diagnosis and preferably before discharge.
The incidence of postpartum anemia in developing countries is 50-80%. This high incidence reflects a combination of reasons including under or late diagnosis, lack of awareness, and early hospital discharge.
Postpartum hemorrhage, particularly after cesarean section (CS), is a leading cause of postpartum anemia (HB <10 g%) as well as significant morbidity and mortality. When bleeding occurs into the abdominal cavity, diagnosis is more difficult and delayed, often only detected when vital signs become unstable. Early diagnosis is crucial for proper management of blood loss and life-saving interventions. Diagnosis includes laboratory tests and imaging modalities, and treatment is determined based on severity, ranging from iron supplementation, blood transfusions, and even surgical interventions if necessary.
A certain amount of intra-abdominal fluid is common after most CS. However, there is no standardized reference in gynecological literature regarding what fluid volume is considered normal or pathological after surgery, nor its association with complications such as pain, infection, or prolonged hospitalization. Studies have shown that free intra-abdominal fluid was detected in 73% of patients after CS using CT scans, whereas ultrasound (US) detected fluid in less than 5% of women.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who delivered by a cesarean section.
- •Fluent in Hebrew or Arabic.
- •Signed informed consent form.
排除标准
- •Lack of consent or inability to provide informed consent.
- •Inability to perform a post-surgical ultrasound, such as post-surgery hospitalization in the intensive care unit.
- •Women with preoperative coagulation disorders.
- •Women whose clinical condition requires a post-cesarean ultrasound examination.
研究组 & 干预措施
Ultrasound group
Group 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery.
干预措施: Ultrasound (Diagnostic Test)
Standard care group
Group 2: Candidates will be managed according to the standard care, i.e., without a routine postpartum ultrasound.
干预措施: Standard care (Other)
结局指标
主要结局
Hemoglobin drop of 2g% or more within 24 - 36 hours
时间窗: 24 -72 hours
The proportion of women with a decrease in Hb levels of over 2 g% identified within 24 hours of surgery in both groups.
次要结局
- HB levels after 4 - 6 weeks(6 weeks postpartum)
- Urine volume in the bladder(up to 72 hours postpartum)
- Rate of women in the study group with intra-abdominal fluid(up to 72 hours postpartum)
- Intra-abdominal fluid volume(up to 72 hours postpartum)
- Presence of intra-abdominal hematomas(up to 72 hours postpartum)
- Postoperative fever(up to 72 hours postpartum)
- Incidence of women with surgical site infection(Postoperative day 2 to day 7.)
- Length of hospital stay(up to 10 days postpartum)
- Maternal discomfort during the ultrasound examination(up to 72 hours postpartum)
- Uterine endometrial diameter(up to 72 hours postpartum)
- Uterine length(up to 72 hours postpartum)
- Maximum vertical depth of intra-abdominal fluid(up to 72 hours postpartum)
- Inferior Vena Cava (IVC) diameter(up to 72 hours postpartum)
- IVC collapsibility index(up to 72 hours postpartum)
- Uterine walls diameter(up to 72 hours postpartum)
- HB levels after 48-72(72 hours postpartum)
- Objective assessment of intraoperative blood loss(up to 72 hours postpartum)
- Administration of blood products(up to 72 hours postpartum)
研究者
Raed Salim, MD
Head of obstetrics and gynecology departement
Holy Family Hospital, Nazareth, Israel