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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01589744
First received: April 25, 2012
Last updated: April 10, 2014
Last verified: April 2014

April 25, 2012
April 10, 2014
July 2012
November 2015   (final data collection date for primary outcome measure)
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization. [ Time Frame: 18 month ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01589744 on ClinicalTrials.gov Archive Site
  • Number of participants for which the setting up of the suction cup in uterus is a successful. [ Time Frame: 18 month ] [ Designated as safety issue: No ]
    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®. [ Time Frame: 18 month ] [ Designated as safety issue: No ]
  • Number of participants for which the withdrawal of the suction cup from the uterus is a successful. [ Time Frame: 18 month ] [ Designated as safety issue: No ]
    Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale.
Same as current
Not Provided
Not Provided
 
Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • No Placental Abruption
  • No Hemorrhage
Device: Suction 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01589744
DCIC 11 24
Yes
AdministrateurCIC, University Hospital, Grenoble
AdministrateurCIC
Not Provided
Principal Investigator: Véronique Equy, MD Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France
University Hospital, Grenoble
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP