No Hemorrhage Clinical Trial
Official title:
Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical
practice, if after giving birth, the placenta is not expelled naturally, an active
management should be triggered. Escalating therapy after obstetric maneuvers (placenta,
uterus, examination of the birth canal), begins with uterotonic treatments for invasive
treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of
these techniques and the desire to preserve fertility required to devise new therapeutic
solutions, which have recently led to the development of an innovative medical device
intrauterine hemostasis.
The postpartum haemorrhage are mainly the result of weak and bleeding from the surface
corresponds to the placental insertion, which is no longer localized. With the innovative
medical device, our main hypothesis is that the uterine walls will append to the walls of
the cup after depressurization of the latter. The actuation of the suction cup will lead to
aspiration of all sides of the uterus (it is mostly the anterior and posterior that are
important). The suction cup is flexible to adapt to the size of the uterus in order to be
placed and removed easily from the uterine cavity.
In this study, as a first pass in Human, innovative medical device not CE marked, we did not aim to show control of the bleeding stops in the case of PPH but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the Intra uterine Haemostatic vacuum and thus a joining of the walls of the uterus. This first step seems essential in order to effectively implement this medical device with serenity in emergency situations of PPH. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research