This trial is terminated!
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More info
You can access this
clinical trial
if you have
No Placental Abruption or No Hemorrhage
and you are
between 18 and 45
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01589744. The sponsor of the trial is AdministrateurCIC and it is looking for 1 volunteers for the current phase.
Official trial title:
Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage