Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of Related SAEs
研究概览
简要总结
Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.
In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.
The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
详细描述
A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.
Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.
The main questions are:
- Rate of device related SAEs up to six weeks following device treatment.
- Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
- Rate of occurrence of uterine inversion of folding during or immediately after device procedure.
Main tasks for participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult Female, 18 years of age or older at time of consent.
- •Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
- •Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum > = 500 ml and according to the Investigator's judgment, require an intervention.
- •Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
排除标准
- •Subjects who do not provide informed consent to participate in the clinical investigation.
- •Subjects who deliver at a uterus size < 34 weeks.
- •Subjects who have lost greater than 1000 ml of blood.
- •Subjects who have abnormal PT, PTT and INR
- •Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
- •PPH that the investigator determines to require more aggressive treatment, including any of the following:
- •Hysterectomy;
- •B-lynch suture;
- •Uterine artery embolization or ligation;
- •Hypogastric ligation.
- •Known uterine anomaly.
- •Ongoing intrauterine pregnancy.
- •Placental abnormality including any of the following:
- •Known placenta accreta;
- •Retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior c-section and placenta previa);
- •Retained placenta without easy manual removal.
- •Known uterine rupture.
- •Unresolved uterine inversion.
结局指标
主要结局
Rate of Related SAEs
时间窗: 6 weeks
Rate of device related SAEs up to six weeks following device treatment.
Rate of Damage to Cervix, Uterus or Vagina
时间窗: When removing the Alma System at the end of the procedure
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Rate of Occurrence of Uterine Inversion or Folding
时间窗: When removing the Alma System at the end of the procedure
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
次要结局
- Time to Visible Reduction in Blood Flow(When removing the Alma System at the end of the procedure)
- User Feedback on Placement of Alma(When removing the Alma System at the end of the procedure)
- User Feedback on Connection to Vacuum(When removing the Alma System at the end of the procedure)
- Rate of Uterine Contraction(When removing the Alma System at the end of the procedure)