NCT06691945尚未招募3 期
Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年11月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Number of participants who have estimated or quantified blood loss of 1,500 mL or more
研究概览
简要总结
The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy
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 (Outcomes Assessor)
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
- •Singletons with a gestational age of 34.0 weeks or more
- •Labor (spontaneous or medical induction)
- •Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)
排除标准
- •Scheduled cesarean delivery
- •Multiple gestations
- •Delivery at < 34.0 weeks
- •Contraindication to place intrauterine pressure catheter (e.g. HIV)
- •Incarcerated subjects
- •Major fetal anomalies requiring neonatal surgical intervention
- •Stillbirth on admission
结局指标
主要结局
Number of participants who have estimated or quantified blood loss of 1,500 mL or more
时间窗: from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products
时间窗: from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy
时间窗: from delivery admission to discharge or up to 12 weeks post delivery
次要结局
- Number of mothers who use uterotonics, in addition to oxytocin(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Estimated blood loss(mL)(post delivery (from immediately after delivery to upto 2 hours after delivery))
- Quantitative blood loss(mL)(post delivery(from immediately after delivery to upto 2 hours after delivery))
- Delta change in hemoglobin of mothers(pre delivery, post partum day 1)
- Number of mothers who have cesarean deliveries(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who need Mechanical tamponade(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who have Chorioamnionitis(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who have endometritis(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who have wound complications (if cesarean delivery)(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of mothers who are admitted to intensive care unit(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of deaths(from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period)
- Number of neonates with Apgar < 7(at 5 minutes after delivery)
- Number of neonates that have a seizure(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of neonates that have meconium aspiration syndrome(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of neonates that have Ventilation > 6 hrs(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of neonates that have Bronchopulmonary dysplasia(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of neonates that have Necrotizing enterocolitis(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of neonates that have Sepsis(delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications)
- Number of stillbirths(at delivery)
- Number of deaths of neonates(within 27 days of birth)
研究者
Sarah Mehl
Fellow
The University of Texas Health Science Center, Houston
研究点 (2)
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