No Hemorrhage, No Placental Abruption
Conditions
Keywords
medical device
Brief summary
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.
Detailed description
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.
Interventions
DEVICESuction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)
The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum.
Sponsors
AdministrateurCIC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization. | 18 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of participants for which the setting up of the suction cup in uterus is a successful. | 18 month | Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale. |
| Number of participants for which the withdrawal of the suction cup from the uterus is a successful. | 18 month | Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale. |
Countries
France
Outcome results
None listed