Clinical trial NCT01589744: Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted
Official title: Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: No Placental Abruption
No Hemorrhage
Keywords: medical device
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization.
timeFrame: 18 month
Secondary outcomes:
measure: Number of participants for which the setting up of the suction cup in uterus is a successful.
timeFrame: 18 month
measure: 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®.
timeFrame: 18 month
measure: Number of participants for which the withdrawal of the suction cup from the uterus is a successful.
timeFrame: 18 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France
name: Véronique Equy, MD
role: PRINCIPAL_INVESTIGATOR
References: