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Vacuum Device for Hemostasis in Obstetrics and Gynecology

2016-06-28 21:23:21 | BioPortfolio

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.

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 its placement in the uterus, the application of vacuum and its removal from the uterus.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Primary Postpartum Hemorrhage

Intervention

Hemostatic Intra-Uterine suction cup

Location

University Hospital Grenoble
Grenoble
France
38043

Status

Not yet recruiting

Source

University Hospital, Grenoble

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-28T21:23:21-0400

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Severe Delayed Postpartum Hemorrhage after Cesarean Section.

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Medical and Biotech [MESH] Definitions

Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum).

A complication of OBSTETRIC LABOR in which the corpus of the UTERUS is forced completely or partially through the UTERINE CERVIX. This can occur during the late stages of labor and is associated with IMMEDIATE POSTPARTUM HEMORRHAGE.

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Antifibrinolytic hemostatic used in severe hemorrhage.

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