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

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.

Study Overview

• Status: Terminated
• Conditions: No Placental Abruption; No Hemorrhage
• Intervention / Treatment: Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Suction cup Hemostatic Intra-Uterin; The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization.	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.	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants for which the setting up of the suction cup in uterus is a successful.	Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale.	18 month
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.	Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale.	18 month

Collaborators and Investigators

• Sponsor: AdministrateurCIC
• Investigators: Principal Investigator: Véronique Equy, MD, Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: April 30, 2012
• First Posted (ESTIMATE): May 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: medical device
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Hemorrhage; Abruptio Placentae; Coagulants; Hemostatics
• Other Study ID Numbers: DCIC 11 24