A Phase III, Open-label, Randomized Clinical Trial to Evaluate Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Life-threatening Postpartum Hemorrhage in Reducing Adverse Maternal Outcome in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Adverse outcome
研究概览
简要总结
Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations.
Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size.
Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.
详细描述
Background
Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum hemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labor is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. In this trial, it is done by an anesthesiologist where a balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of inflation.
Objective
To assess the efficacy and safety of the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum hemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study statistician will be masked.
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with life-threatening PPH, defined as either:
- •Ongoing PPH and a systolic blood pressure equal to or less than 80 mm Hg, or
- •Ongoing PPH, a systolic blood pressure equal to or less than 90 mg Hg and the administration of vasoactive drugs, or
- •Ongoing PPH and a systolic blood pressure equal to or less than 90 mg Hg as well as a pulse greater than or equal to 120 beats per minute recorded simultaneously
- •Consent, Deferred consent since 3rd September 2024
排除标准
- •Prior cardiac arrest
- •Intra-abdominal pregnancy
结局指标
主要结局
Adverse outcome
时间窗: 42 days
The proportion of participants with a composite outcome of either maternal death (=death within 42 days post-partum) or emergency hysterectomy
次要结局
- Maternal death(42 days)
- Emergency hysterectomy(42 days)
- Acute kidney injury(42 days)
- Adverse outcome excluding 'inevitable' hysterectomies(42 days)
- Number of AEs and SAEs(42 days)
- Hemoglobin(42 days)
- Transfusions(42 days)