Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage

Conditions
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No Placental Abruption, No Hemorrhage

Intervention / Treatment
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* Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suction cup Hemostatic Intra-Uterin<br>The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage | Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical device