Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of the feasibility of using the hemostatic intrauterine suction cup in patients who present primary PPH (blood loss ≥ 500ml) after a vaginal childbirth requiring the administration of Nalador®.
研究概览
简要总结
Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.
In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.
Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.
Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.
详细描述
In this study, as a first pass in human of this innovative non CE marked medical device, we aim to demonstrate the feasibility of using the hemostatic intrauterine suction cup for patients who present primary PPH (blood loss ≥ 500ml) after a vaginal delivery requiring administration of Nalador®. We will evaluate the placement of hemostatic suction cup in the uterus, the application of vacuum and its removal from the uterus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 18 and 45 years old
- •patient under loco-regional anesthesia
- •patient who presents primary postpartum hemorrhage (blood loss ≥ 500ml) after a vaginal childbirth requiring administration of Nalador®.
- •affiliation to the French social security system or equivalent
- •patient who has signed a consent to participate
排除标准
- •patient with a uterine malformation
- •patient allergic to silicon
- •patient under general anesthesia
- •patient who delivered via caesarean section
- •patient with fever or suspected infection during labor
- •person deprived of freedom by judicial or administrative decision
- •person hospitalized without their consent
- •person under legal protection
- •person hospitalized for psychiatric care
结局指标
主要结局
Evaluation of the feasibility of using the hemostatic intrauterine suction cup in patients who present primary PPH (blood loss ≥ 500ml) after a vaginal childbirth requiring the administration of Nalador®.
时间窗: 36 month
The primary outcome is composite and consists of 3 the following component outcomes: 1. Qualification of success or failure of the introduction of the suction cup in the uterine cavity 2. Qualification of success or failure to create negative pressure in the suction cup. The negative pressure is validated if vacuum is maintained for at least 30 seconds. 3. Qualification of success or failure of removing the suction cup in its entirety. The feasibility of using the suction cup will be validated if success is obtained for the 3 component outcomes.
次要结局
- Evaluation of the ease of the placement of the suction cup by the clinician(36 month)
- Evaluation of whether the bleeding stops after each time the suction cup is put under vacuum. For each patient, the cup may be put once or twice under vacuum.(36 month)
- Evaluation of the ease of removal of the suction cup by the clinician(36 month)
- Quantification of blood loss during delivery(36 month)
- Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding(36 month)
- Assessment of the duration of time required to place and remove the suction cup(36 month)