The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures: A Multi-Site Longitudinal Study An Initiative Under the East African Women's Health Network (EAWoHNet)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Composite clinical outcome
研究概览
简要总结
The broad objective of the study is to determine if the Bakri Postpartum Balloon is effective in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of a standardized management algorithm.
Specific Objectives
- To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, but prior to the inclusion of the Bakri Postpartum Balloon as part of the protocol.
- To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, after the inclusion of the Bakri Postpartum Balloon as part of the protocol.
- To compare morbidity
- To generate preliminary data for (a) a larger confirmatory study of the use of the Bakri Postpartum Balloon in centers with surgical and blood transfusion services, and (b) design of a pilot study of the use of the Bakri device of temporary control of PPH in settings outside of surgical centers (such as by trained midwives or emergency transport personnel).
详细描述
Phase I: Development and training of staff in standardized algorithm for management of PPH using available local resources (not including Bakri balloon).
Phase II: Data collection after introduction of the standardized algorithm.
Phase III: Revision of protocol to include the Bakri Postpartum Device
Phase IV: Data collection after introduction of the Bakri device
Bakri Postpartum Balloon 510K Premarket Notification/Cook OBGYN #K062438
研究设计
- 研究类型
- Observational
- 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
- •Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage, defined as
- •Clinically estimated blood loss of greater than 500 ml for a vaginal delivery, or
- •Clinically estimated blood loss of greater than 1000 ml for a cesarean delivery, or
- •Hemodynamic changes that, in the opinion of the care team, require interventions beyond routine postpartum or postdelivery care (such as intravenous fluids or the use of more than one uterotonic agent).
排除标准
- •Minors (less than 18 years of age)
- •Arterial bleeding requiring surgical exploration or angiographic embolization
- •Cases requiring immediate lifesaving hysterectomy
- •Ongoing intrauterine pregnancy
- •Cervical cancer
- •Purulent infections of the vagina, cervix or uterus
- •Untreated uterine anomaly
- •Disseminated intravascular coagulation
- •A surgical site which would prohibit the device from effectively controlling bleeding
- •Patients who are referred for obstructed labor
- •Patients with signs, symptoms or other evidence of ruptured uterus
结局指标
主要结局
Composite clinical outcome
时间窗: 24 hours
The primary outcome of the study is a composite clinical outcome consisting of: * Blood transfusion * Renal failure (creatinine \>1.5 mg/dL or increased \>1.0 mg/dL above baseline, oliguria \<120 ml output in 4 hour intervals) * Respiratory impairment (impairment of respiratory function requiring ventilation, oxygen supplementation, or decreased physical activity compared to pre-pregnancy levels) * Central nervous system impairment (seizures, loss of consciousness, or cognitive/motor loss) * Heart failure (NYHA class III or IV) * Disseminated intravascular coagulation (DIC) based on clinical and laboratory assessment if available. * Abdominal surgery to control hemorrhage in non-cesarean patients * Emergency hysterectomy. Outcomes and definitions are similar to those used in other studies of PPH management in Africa.
次要结局
- Unit of estimated blood loss(24 hours)