Vacuum Device for Hemostasis in Obstetrics and Gynecology

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Jun 24, 2016

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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