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Vacuum Device for Hemostasis in Obstetrics and Gynecology (HEMOGYN2)

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ClinicalTrials.gov Identifier: NCT02816203
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Clinical Investigation Centre for Innovative Technology Network
HEMOSQUID
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.

In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.

Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.

Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.


Condition or disease Intervention/treatment Phase
Primary Postpartum Hemorrhage Administration of Sulprostone Vaginal Childbirth Device: Hemostatic Intra-Uterine suction cup Not Applicable

Detailed Description:
In this study, as a first pass in human of this innovative non CE marked medical device, we aim to demonstrate the feasibility of using the hemostatic intrauterine suction cup for patients who present primary PPH (blood loss ≥ 500ml) after a vaginal delivery requiring administration of Nalador®. We will evaluate the placement of hemostatic suction cup in the uterus, the application of vacuum and its removal from the uterus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Hemostatic Intra-Uterine suction cup
Patients who present primary postpartum hemorrhage requiring administration of Nalador and the suction cup placed in the uterine cavity
Device: Hemostatic Intra-Uterine suction cup
The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.




Primary Outcome Measures :
  1. Evaluation of the feasibility of using the hemostatic intrauterine suction cup in patients who present primary PPH (blood loss ≥ 500ml) after a vaginal childbirth requiring the administration of Nalador®. [ Time Frame: 36 month ]

    The primary outcome is composite and consists of 3 the following component outcomes:

    1. Qualification of success or failure of the introduction of the suction cup in the uterine cavity
    2. Qualification of success or failure to create negative pressure in the suction cup. The negative pressure is validated if vacuum is maintained for at least 30 seconds.
    3. Qualification of success or failure of removing the suction cup in its entirety.

    The feasibility of using the suction cup will be validated if success is obtained for the 3 component outcomes.



Secondary Outcome Measures :
  1. Evaluation of the ease of the placement of the suction cup by the clinician [ Time Frame: 36 month ]
    Visual quantitative satisfaction scale

  2. Evaluation of whether the bleeding stops after each time the suction cup is put under vacuum. For each patient, the cup may be put once or twice under vacuum. [ Time Frame: 36 month ]
    Subjective evaluation of whether bleeding stops by the clinician after each time the suction cup is put under vacuum.

  3. Evaluation of the ease of removal of the suction cup by the clinician [ Time Frame: 36 month ]
    Visual quantitative satisfaction scale

  4. Quantification of blood loss during delivery [ Time Frame: 36 month ]
    Volume of blood collected in the container of the pump and in the collection bag from the beginning of the delivery until the removal of the suction cup

  5. Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding [ Time Frame: 36 month ]
    Number of patients for whom embolization or surgery is indicated

  6. Assessment of the duration of time required to place and remove the suction cup [ Time Frame: 36 month ]
    Time duration for the placement and removal of the suction cup



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women between 18 and 45 years old
  • patient under loco-regional anesthesia
  • patient who presents primary postpartum hemorrhage (blood loss ≥ 500ml) after a vaginal childbirth requiring administration of Nalador®.
  • affiliation to the French social security system or equivalent
  • patient who has signed a consent to participate

Exclusion Criteria:

  • patient with a uterine malformation
  • patient allergic to silicon
  • patient under general anesthesia
  • patient who delivered via caesarean section
  • patient 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816203


Contacts
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Contact: Véronique Equy, MD +33 476 765 400 VEquy@chu-grenoble.fr
Contact: Emilie Chipon, PhD +33 476 767 313 echipon@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: Véronique Equy, MD    +33 476 765 400    VEquy@chu-grenoble.fr   
Contact: Isabelle Boudry, PhD    +33 476 766 645    iboudry@chu-grenoble.fr   
Sub-Investigator: Coston Anne-Laure, MD         
Sub-Investigator: Dunand-Faure Camille, MD         
Sub-Investigator: Gueniffey Aurore, MD         
Sub-Investigator: Guigue Virginie, MD         
Sub-Investigator: Hoffmann Pascale, MD         
Sub-Investigator: Istasse François, MD         
Sub-Investigator: Michy Thierry, MD         
Sub-Investigator: Philippe Anne-Cécile, MD         
Sub-Investigator: Gobillot Sophie, MD         
Sub-Investigator: Thong-Vanh Catherine, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network
HEMOSQUID
Investigators
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Principal Investigator: Véronique Equy, MD Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02816203    
Other Study ID Numbers: 38RC15.060
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Hemostatics
Coagulants