NCT02816203

Vacuum Device for Hemostasis in Obstetrics and Gynecology

Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Postpartum Hemorrhage
• Administration of Sulprostone
• Vaginal Childbirth

Interventions

Type	Name	Description
DEVICE	Hemostatic Intra-Uterine suction cup	The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-06-28
• Last updated: 2023-03-03

Locations

1 site across 1 country: France