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

Not Applicable

Terminated

• Conditions: No Hemorrhage; No Placental Abruption
• Interventions: Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)

• Registration Number: NCT01589744
• Lead Sponsor: AdministrateurCIC

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.

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Study Start: 2012-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suction cup Hemostatic Intra-Uterin	Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)	The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.	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.

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France