NCT04409015已完成不适用
ROTEM® Obstetric Hemorrhage Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
研究概览
简要总结
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor &Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age ≥ 18 years and able to provide consent
- •Gestational age ≥ 34 weeks
- •≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
- •Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score <5)
- •Prior uterine surgery (> 1 prior cesarean or myomectomy)
- •Patients undergoing trial of labor after cesarean delivery
- •History of postpartum hemorrhage
- •≥4 previous vaginal deliveries
- •Multiple gestation
- •The presence of > 2 uterine fibroids or fibroid > 5 cm on any ultrasound during the pregnancy
- •Planned magnesium sulfate use
- •Placenta previa/accreta/increta/percreta
排除标准
- •Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
- •Antepartum hemorrhage present on admission (>500cc Estimated Blood Loss (EBL))
- •Coagulation defects
- •Thrombocytopenia with platelets count <100,000
- •Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.
结局指标
主要结局
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
时间窗: After delivery through study completion, an average of 2 years
次要结局
- Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating volume of estimated and quantitative blood loss(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating frequency of blood transfusion and related morbidities(Pre and post-delivery through study completion, an average of 2 years)
- Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery(Pre and post-delivery through study completion, an average of 2 years)
研究者
Michael Cackovic
MD, Associate Professor
Ohio State University
研究点 (1)
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