No Hemorrhage Clinical Trial
— HEMOGYNOfficial 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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - woman between 18 and 45 years old, - affiliation to the French social security system or equivalent, - volunteers signed a consent to participate, - volunteer is under loco-regional anaesthesia, - volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery. Exclusion Criteria: - volunteer carries uterine malformations, - volunteer with post-partum haemorrhage (blood loss> 500 ml), - volunteer allergic to silicon, - volunteer under general anaesthesia, - pregnancy not unique, - volunteer 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital Grenoble | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| AdministrateurCIC |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization. | Comparison of ultrasound images before and after depression in the suction cup. The joining of tissues on the suction cup is characterized by a better visualization of posterior structures following the depressurization by eliminating air in the haemostatic intra-uterine suction cup. | 18 month | No |
| Secondary | Number of participants for which the setting up of the suction cup in uterus is a successful. | Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale. | 18 month | No |
| Secondary | Number of participant for which there is a persistence of the joining walls of the uterus around the suction cup between 1 and 5 minutes at maximum after passage of the depression with Redon Drainobag®. | 18 month | No | |
| Secondary | Number of participants for which the withdrawal of the suction cup from the uterus is a successful. | Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale. | 18 month | No |