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
  Purpose

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.


Condition Intervention
No Placental Abruption
No Hemorrhage
Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589744

Locations
France
University Hospital Grenoble
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
Investigators
Principal Investigator: Véronique Equy, MD Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France
  More Information

Additional Information:
No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01589744     History of Changes
Other Study ID Numbers: DCIC 11 24
Study First Received: April 25, 2012
Last Updated: April 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
medical device

Additional relevant MeSH terms:
Abruptio Placentae
Hemorrhage
Postpartum Hemorrhage
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Pathologic Processes
Puerperal Disorders
Uterine Hemorrhage
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014